[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

Exhibit 10.17

LICENSE AND RESEARCH AGREEMENT

BY AND BETWEEN

CALITHERA BIOSCIENCES INC.

AND

HIGH POINT PHARMACEUTICALS, LLC
TRANSTECH PHARMA LLC

DATED AS OF MARCH 5, 2015

 

 

 

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

 

TABLE OF CONTENTS

 

 

 

 

 

Page

 

ARTICLE I.

 

 

DEFINITIONS

 

1

 

1.1.

 

 

“Acceptable Human Exposure”

 

1

1.2.

 

“Act”

 

1

1.3.

 

“Affiliate”

 

1

1.4.

 

“Bankruptcy Code”

 

1

1.5.

 

“Business Day”

 

1

1.6.

 

“Calendar Quarter”

 

1

1.7.

 

“Calendar Year”

 

1

1.8.

 

“Calithera-Derived Molecule”

 

1

1.9.

 

“Calithera Intellectual Property”

 

1

1.10.

 

“Calithera Know-How”

 

2

1.11.

 

“Calithera Patent Rights”

 

2

1.12.

 

“Clinical Candidate”

 

2

1.13.

 

“Combination Product”

 

2

1.14.

 

“Commercialization” or “Commercialize”

 

2

1.15.

 

“Commercially Reasonable Efforts”

 

2

1.16.

 

“Control” or “Controlled”

 

2

1.17.

 

“Cover”, “Covering” or “Covered”

 

2

1.18.

 

“Covered Period”

 

2

1.19.

 

“Development” or “Develop”

 

2

1.20.

 

“Development Plan”

 

3

1.21.

 

“Development Term”

 

3

1.22.

 

“EMA”

 

3

1.23.

 

“EU”

 

3

1.24.

 

“FDA”

 

3

1.25.

 

“Field”

 

3

1.26.

 

“First Commercial Sale”

 

3

1.27.

 

“FTE”

 

3

1.28.

 

“FTE Rate”

 

3

1.29.

 

“GAAP”

 

3

1.30.

 

“Generic Competition”

 

3

1.31.

 

“Generic Product”

 

3

1.32.

 

“Governmental Authority”

 

3

1.33.

 

“Hexokinase Inhibitor”

 

3

1.34.

 

“High Point Intellectual Property”

 

3

1.35.

 

“High Point Know-How”

 

4

1.36.

 

“High Point Molecule”

 

4

1.37.

 

“High Point Patent Rights”

 

4

1.38.

 

“HPP399”

 

4

1.39.

 

“IND”

 

4

1.40.

 

“IND Enabling GLP Toxicology Study”

 

4

1.41.

 

“Indication”

 

4

1.42.

 

“Initiation”

 

4

1.43.

 

“Know-How”

 

4

 

- i -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

1.44.

 

“Law” or “Laws”

 

4

1.45.

 

“Legal Exclusivity”

 

4

1.46.

 

“Licensed Product”

 

4

1.47.

 

“Losses”

 

4

1.48.

 

“Major EU Country”

 

5

1.49.

 

“Major Markets”

 

5

1.50.

 

“Manufacture” or “Manufacturing”

 

5

1.51.

 

“Marketing Authorization”

 

5

1.52.

 

“MHLW”

 

5

1.53.

 

“NDA”

 

5

1.54.

 

“Net Sales”

 

5

1.55.

 

“Objective Response”

 

6

1.56.

 

“Party”

 

6

1.57.

 

“Patent Rights”

 

6

1.58.

 

“Person”

 

6

1.59.

 

“Phase I Clinical Trial”

 

6

1.60.

 

“Phase II Clinical Trial”

 

6

1.61.

 

“Phase III Clinical Trial”

 

6

1.62.

 

“Program Molecule”

 

7

1.63.

 

“Program Patent Rights”

 

7

1.64.

 

“Regulatory Approval”

 

7

1.65.

 

“Regulatory Authority”

 

7

1.66.

 

“Research Plan”

 

7

1.67.

 

“Research Program”

 

7

1.68.

 

“Research Program Term”

 

7

1.69.

 

“ROW”

 

7

1.70.

 

“Small Molecule”

 

7

1.71.

 

“Sublicensee”

 

7

1.72.

 

“Territory”

 

7

1.73.

 

“Third Party”

 

7

1.74.

 

“Valid Claim”

 

7

1.75.

 

Additional Definitions

 

8

 

ARTICLE II.

 

 

GRANTS OF RIGHTS

 

9

 

2.1.

 

 

High Point Grants of Rights

 

9

2.2.

 

Calithera Grants of Rights

 

9

2.3.

 

Rights Retained by the Parties

 

9

2.4.

 

Section 365(n) of the Bankruptcy Code

 

9

2.5.

 

Exclusivity

 

9

 

ARTICLE III.

 

 

RESEARCH

 

10

3.1.

 

General

 

10

3.2.

 

High Point FTE Commitments

 

10

3.3.

 

Research Program Coordinators

 

10

3.4.

 

Calithera Contributions

 

10

3.5.

 

High Point Assistance

 

10

 

ARTICLE IV.

 

 

DEVELOPMENT

 

11

 

4.1.

 

 

General

 

11

 

- ii -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

4.2.

 

Development Forum

 

11

4.3.

 

Exchange of Information Regarding Development

 

11

 

ARTICLE V.

 

 

COMMERCIALIZATION

 

11

 

5.1.

 

 

General

 

11

5.2.

 

Commercialization Plans

 

11

 

ARTICLE VI.

 

 

DILIGENCE

 

12

 

6.1.

 

 

Commercially Reasonable Efforts

 

12

6.2.

 

Specific Efforts with Respect to Program Molecules and Licensed Products

 

12

6.3.

 

Failure to Meet Diligence Obligations

 

12

 

ARTICLE VII.

 

FINANCIAL PROVISIONS

 

12

 

7.1.

 

 

Initial License Payment

 

12

7.2.

 

Research Program

 

12

7.3.

 

Development, Manufacturing and Commercialization Costs

 

13

7.4.

 

Event Milestone Payments

 

13

7.5.

 

Sales Milestone Payments

 

14

7.6.

 

Licensed Product Royalties

 

14

7.7.

 

Reports; Payments

 

15

7.8.

 

Books and Records; Audit Rights

 

15

7.9.

 

Taxes

 

15

7.10.

 

Payment Method and Currency Conversion

 

16

7.11.

 

Blocked Payments

 

16

7.12.

 

Late Payments

 

16

 

ARTICLE VIII.

 

INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION

AND RELATED MATTERS

 

16

 

8.1.

 

 

Ownership of Inventions

 

16

8.2.

 

Prosecution and Maintenance of Patent Rights

 

17

8.3.

 

Third Party Infringement

 

18

8.4.

 

Patent Invalidity Claim

 

19

8.5.

 

Patent Term Extensions

 

19

8.6.

 

Patent Marking

 

19

8.7.

 

Interpretation of Patent Judgments

 

19

8.8.

 

Certification under Drug Price Competition and Patent Restoration Act

 

19

8.9.

 

Consents as to Joint Inventions and Joint Patents

 

19

 

ARTICLE IX.

 

 

CONFIDENTIAL INFORMATION

 

20

 

9.1.

 

 

Treatment of Confidential Information

 

20

9.2.

 

Confidential Information

 

20

9.3.

 

Publication Rights

 

21

9.4.

 

Restrictions on Material Non-Public Information

 

21

 

ARTICLE X.

 

 

REPRESENTATIONS, WARRANTIES AND COVENANTS

 

21

 

10.1.

 

 

High Point’s Representations

 

21

10.2.

 

Calithera’s Representations

 

22

10.3.

 

Mutual Covenant

 

23

10.4.

 

No Warranty

 

23

 

- iii -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

 

ARTICLE XI.

 

 

INDEMNIFICATION

 

23

 

11.1.

 

 

Indemnification in Favor of High Point

 

23

11.2.

 

Indemnification in Favor of Calithera

 

23

11.3.

 

General Indemnification Procedures

 

24

 

ARTICLE XII.

 

 

TERM AND TERMINATION

 

24

 

12.1.

 

 

Term

 

24

12.2.

 

Termination for Convenience

 

25

12.3.

 

Termination for Breach

 

25

12.4.

 

Termination for Insolvency

 

25

12.5.

 

Consequences of Certain Terminations by the Parties

 

25

12.6.

 

Payment of Balance of Quarterly Research Fees

 

27

12.7.

 

Unblock License

 

28

12.8.

 

Effect of Termination and Expiration; Accrued Rights and Obligations

 

28

12.9.

 

Survival

 

28

 

ARTICLE XIII.

 

 

MISCELLANEOUS

 

28

 

13.1.

 

 

Governing Law

 

28

13.2.

 

Jurisdiction

 

28

13.3.

 

Waiver

 

28

13.4.

 

Notices

 

28

13.5.

 

Entire Agreement

 

29

13.6.

 

Headings

 

30

13.7.

 

Severability

 

30

13.8.

 

Registration and Filing of the Agreement

 

30

13.9.

 

Assignment

 

30

13.10.

 

Counterparts

 

30

13.11.

 

Force Majeure

 

30

13.12.

 

Press Releases and Other Disclosures

 

30

13.13.

 

Third Party Beneficiaries

 

31

13.14.

 

Relationship of the Parties

 

31

13.15.

 

Performance by Affiliates

 

31

13.16.

 

Construction

 

31

13.17.

 

No Consequential or Punitive Damages

 

31

 

 

 

 

- iv -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

LICENSE AND RESEARCH AGREEMENT

THIS LICENSE AND RESEARCH AGREEMENT is entered into this 5th day of March, 2015
(the “Effective Date”) by and between Calithera Bioscience Inc., a corporation
organized under the laws of the State of Delaware, having a business address at
343 Oyster Point Blvd #200, South San Francisco, CA 94080 (“Calithera”), on the
one hand, and High Point Pharmaceuticals, LLC, a company organized under the
laws of the State of Delaware, having a business address at 4170 Mendenhall Oaks
Parkway, High Point, NC 27265 (“HPP”) and TransTech Pharma LLC, a company
organized under the laws of the State of Delaware, having a business address at
4170 Mendenhall Oaks Parkway, High Point, NC 27265 (“TransTech” and collectively
with HPP, “High Point”), on the other hand.

WHEREAS, High Point has developed or obtained rights to High Point Patent Rights
(as hereinafter defined) and High Point Know-How (as hereinafter defined);

WHEREAS, High Point has developed certain Hexokinase Inhibitors (as hereinafter
defined), and Calithera wishes to fund a research program that will include the
development of additional Hexokinase Inhibitors by High Point; and

WHEREAS, Calithera desires to obtain an exclusive license under the High Point
Patent Rights and the High Point Know-How to make and use such Hexokinase
Inhibitors, and to develop and commercialize Licensed Products (as hereinafter
defined), under the terms and conditions set forth herein, and High Point
desires to grant such a license.

NOW, THEREFORE, the Parties agree as follows:

ARTICLE I.

DEFINITIONS

The following terms, whether used in the singular or plural, shall have the
following meanings:

1.1. “Acceptable Human Exposure”. Acceptable Human Exposure means the
demonstration of all of the following in a clinical trial of a Licensed Product:
(a) [*]; (b) [*]; and (c) [*].

1.2. “Act”. Act means both the United States Federal Food, Drug, and Cosmetic
Act, as amended from time to time, and the regulations promulgated under the
foregoing.

1.3. “Affiliate”. Affiliate means any Person directly or indirectly controlled
by, controlling or under common control with, a Party, but only for so long as
such control shall continue. For purposes of this definition, “control”
(including, with correlative meanings, “controlled by”, “controlling” and “under
common control with”) means, with respect to a Person, possession, direct or
indirect, of (a) the power to direct or cause direction of the management and
policies of such Person (whether through ownership of securities or partnership
or other ownership interests, by contract or otherwise), or (b) at least 50% of
the voting securities or other comparable equity interests of such Person.

1.4. “Bankruptcy Code”. Bankruptcy Code means Title 11 of the United States
Code, as amended from time to time.

1.5. “Business Day”. Business Day means a day that is not a Saturday, Sunday or
a day on which banking institutions in New York City, New York are authorized or
required by Law to remain closed.

1.6. “Calendar Quarter”. Calendar Quarter means each of the periods ending on
March 31, June 30, September 30 and December 31 of any year.

1.7. “Calendar Year”. Calendar Year means each calendar year during the Term.

1.8. “Calithera-Derived Molecule”. Calithera-Derived Molecule means any
Hexokinase Inhibitor that is (a) [*] or [*], (b) [*] or [*] or [*], or (c) [*]
or [*]. Notwithstanding the foregoing, Calithera-Derived Molecule [*] either [*]
or [*].

1.9. “Calithera Intellectual Property”. Calithera Intellectual Property means
the Calithera Know-How and the Calithera Patent Rights.

 

- 1 -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

1.10. “Calithera Know-How”. Calithera Know-How means all Know-How that is
Controlled by Calithera as of the Effective Date or thereafter during the Term
and that is necessary or reasonably needed to research, Develop or Manufacture
any Program Molecule or any Licensed Product.

1.11. “Calithera Patent Rights”. Calithera Patent Rights means (a) all Patent
Rights that are Controlled by Calithera as of the Effective Date or thereafter
during the Term and that is necessary or reasonably needed to research, Develop
or Manufacture any Program Molecule or any Licensed Product and (b) Program
Patent Rights.

1.12. “Clinical Candidate”. Clinical Candidate means a Program Molecule that:

(a) is shown to have the following profile:

(i) [*]; or

(b) is selected by Calithera as, or otherwise is, the subject of [*].

1.13. “Combination Product”. Combination Product means (a) any pharmaceutical
product that is a single formulation consisting of a Program Molecule and one or
more other active compounds or active ingredients, which other active compounds
or active ingredients are not another Program Molecule, are not Covered by a
High Point Patent Right or Program Patent Right, and do not embody any High
Point Know-How, in all such cases prior to such other active compound or active
ingredient (“Other API”) being combined with such Program Molecule or (b) any
combination of a Program Molecule sold together with any separately formulated
Other API for a single invoiced price.

1.14. “Commercialization” or “Commercialize”. Commercialization or Commercialize
means activities directed to obtaining pricing and reimbursement approvals,
marketing, promoting, distributing, importing or selling a product. For purposes
of clarity, Commercialization shall not include any activities related to
Manufacturing.

1.15. “Commercially Reasonable Efforts”. Commercially Reasonable Efforts means,
with respect to a Program Molecule or Licensed Product, the carrying out of
obligations under this Agreement with those efforts and resources that a
biotechnology company of similar size and resources to Calithera would use were
it Developing or Commercializing its own pharmaceutical products that are of
similar stage of Development or Commercialization or market potential as the
Licensed Product, taking into account product profile, product labeling or
anticipated labeling, present and future market potential, strength and duration
of patent protection and anticipated exclusivity, past performance of Licensed
Products, financial return, safety, efficacy and other medical and clinical
considerations, present and future regulatory environment and competitive market
conditions, launching strategy and other relevant scientific, technical, legal,
operational and commercial factors, all as measured by the facts and
circumstances at the time such efforts are due.

1.16. “Control” or “Controlled”. Control or Controlled means, with respect to
any intellectual property right or other intangible or tangible property, the
possession (whether by ownership or license (other than pursuant to this
Agreement)) by a Party of the ability to grant to the other Party a license or
sublicense or access as provided herein without violating the terms of any
agreement with any other Person.

1.17. “Cover”, “Covering” or “Covered”. Cover, Covering or Covered means, with
respect to a product, technology, process or method that, in the absence of
ownership of or a license granted under a Valid Claim, the manufacture, use,
offer for sale, sale or importation of such product or the practice of such
technology, process or method would infringe such Valid Claim (or, in the case
of a Valid Claim that has not yet issued, would infringe such Valid Claim if it
were to issue).

1.18. “Covered Period”. Covered Period means the period commencing on the
Effective Date and ending on [*].

1.19. “Development” or “Develop”. Development or Develop means pre-clinical and
clinical research and drug development activities, including toxicology and
other pre-clinical development efforts, stability testing, process development,
formulation development, delivery system development, quality assurance and
quality control development, statistical analysis, clinical pharmacology,
clinical studies (including pre- and post-approval studies and investigator
sponsored clinical studies), regulatory affairs, and Regulatory Approval and
clinical study regulatory activities (excluding regulatory activities directed
to obtaining pricing and reimbursement approvals). For purposes of clarity,
“Development” and “Develop” excludes basic research, screening and

 

- 2 -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

discovery activities, including molecular biology, biochemistry and pre-clinical
pharmacology, directed to the identification of new compounds or molecules.

1.20. “Development Plan”. Development Plan means the plan for the clinical
Development of Licensed Products in the Field in the Territory as it may be
modified from time to time, from which Calithera may redact proprietary
information as well as information that is not relevant to Licensed Products.

1.21. “Development Term”. Development Term means, with respect to a Program
Molecule, the period commencing on the Effective Date and ending as of the date
of the First Commercial Sale of a Licensed Product containing such Program
Molecule to occur for any Indication in any Major Market.

1.22. “EMA”. EMA means The European Medicines Agency and any successor agency
thereto.

1.23. “EU”. EU means the European Union, as it may be redefined from time to
time.

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

1.25. “Field”. Field means any therapeutic, prophylactic, preventative or
diagnostic use.

1.26. “First Commercial Sale”. First Commercial Sale means, with respect to a
Licensed Product in a country, the earlier of the issuance of the first invoice
or the receipt of the first payment for a shipment of a Licensed Product in
commercial quantities for commercial sale by Calithera, its Affiliates or its
Sublicensees to a Third Party after receipt of the first Regulatory Approval for
such Licensed Product in such country.

1.27. “FTE”. FTE means a full-time equivalent person year (consisting of a total
of [*] hours per year) of scientific, technical or managerial (but not
administrative) research work. An individual who works more than [*] hours in a
year will be treated as one FTE regardless of the number of hours worked.

1.28. “FTE Rate”. FTE Rate means $275,000 per FTE.

1.29. “GAAP”. GAAP means accounting principles generally accepted in the United
States of America, as in effect from time to time.

1.30. “Generic Competition”. Generic Competition exists, with respect to a
Licensed Product in any country in the Territory in a given Calendar Quarter,
if, during such Calendar Quarter, one or more Generic Products are commercially
available in such country.

1.31. “Generic Product”. Generic Product means, with respect to a given Licensed
Product, any pharmaceutical product sold by a Third Party, not authorized by
Calithera, its Affiliates or Sublicensees, that (a) contains as an active
pharmaceutical ingredient a Program Molecule included in such Licensed Product
or a prodrug, metabolite, salt, ester, hydrate, solvate, polymorph,
stereoisomer, enantiomer, free acid form, crystal form, free base form, or
racemate of such Program Molecule, and (b) is either (i) approved for sale in
reliance on, in whole or in part, the prior approval of such Licensed Product as
determined by the applicable Regulatory Authority, or (ii) is otherwise
substitutable for such Licensed Product under applicable Laws by a pharmacist
without the intervention of the prescribing physician.

1.32. “Governmental Authority”. Governmental Authority means any United States
federal, state or local or any foreign government, or political subdivision
thereof, or any multinational organization or authority or any authority, agency
or commission entitled to exercise any administrative, executive, judicial,
legislative, police, regulatory or taxing authority or power, any court or
tribunal (or any department, bureau or division thereof), or any governmental
arbitrator or arbitral body.

1.33. “Hexokinase Inhibitor”. Hexokinase Inhibitor means any Small Molecule
having the following characteristic: [*] assay described in Schedule 1.33.

1.34. “High Point Intellectual Property”. High Point Intellectual Property means
the High Point Know-How and the High Point Patent Rights and all of High Point’s
rights in the Joint Inventions and Joint Patents.

 

- 3 -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

1.35. “High Point Know-How”. High Point Know-How means any Know-How that is
Controlled by High Point as of the Effective Date or thereafter during the Term
and that is necessary or reasonably needed to Develop, make, have made, use,
sell, offer for sale or import Program Molecules or Licensed Products.

1.36. “High Point Molecule”. High Point Molecule means (a) any Hexokinase
Inhibitor that is (i) Controlled by High Point as of the Effective Date, (ii)
disclosed or claimed in the High Point Patent Rights, or (iii) invented solely
by or on behalf of High Point in the conduct of the Research Program or (b) any
other Small Molecule disclosed or claimed in the High Point Patent Rights
existing as of the Effective Date. For clarity, HPP399 is a High Point Molecule.

1.37. “High Point Patent Rights”. High Point Patent Rights means (a) all Patent
Rights that are Controlled by High Point as of the Effective Date or thereafter
during the Term that are necessary or reasonably needed to Develop, make, have
made, use, sell, offer for sale or import Program Molecules or Licensed Products
and (b) High Point’s interest in the Joint Patents. The High Point Patent Rights
existing as of the Effective Date are set forth on Schedule 1.37.

1.38. “HPP399”. HPP399 means the molecule identified by High Point using High
Point’s internal reference number 00309399, the structure of which High Point
has disclosed to Calithera as of the Effective Date. For purposes of clarity,
HPP399 shall be deemed to be a Hexokinase Inhibitor.

1.39. “IND”. IND means an investigational new drug application filed with the
FDA with respect to a Licensed Product, or equivalent application filed with the
Regulatory Authority of a country in the Territory other than the United States.

1.40. “IND Enabling GLP Toxicology Study”. IND Enabling GLP Toxicology Study
means a toxicology (acute or sub-chronic), genotoxicity, or safety pharmacology
study that meets the requirements set forth in 21 C.F.R. Part 58 or comparable
regulations in countries outside the United States pertaining to good laboratory
practice for use or intended for use in an IND, but excluding any toxicology
study performed in the course of evaluating compounds prior to the selection of
a Clinical Candidate.

1.41. “Indication”. Indication means the description of use of a Licensed
Product in the treatment, prevention or diagnosis of a recognized disease or
condition as provided for in the Code of Federal Regulations (CFR) labeling
requirements in 21 CFR Part 201 – Labeling. For the purposes of this Agreement,
a new Indication [*] or [*].

1.42. “Initiation”. Initiation means, with respect to any Phase I Clinical
Trial, Phase II Clinical Trial or Phase III Clinical Trial, the date on which
the first volunteer or patient in such trial has received his or her initial
dose.

1.43. “Know-How”. Know-How means proprietary, non-public information and
materials, whether patentable or not, including (a) ideas, discoveries,
inventions, improvements or trade secrets, (b) pharmaceutical, chemical and
biological materials, products and compositions, (c) tests, assays, techniques,
data, methods, procedures, formulas, or processes, (d) technical, medical,
clinical, toxicological and other scientific data and other information relating
to any of the foregoing, and (e) drawings, plans, designs, diagrams, sketches,
specifications or other documents containing or relating to such information or
materials.

1.44. “Law” or “Laws”. Law or Laws means all laws, statutes, rules, regulations,
orders, judgments or ordinances of any Governmental Authority.

1.45. “Legal Exclusivity”. Legal Exclusivity means, with respect to a Licensed
Product and a country or region, the right to exclude any Person who is not a
Calithera Affiliate or a Sublicensee from Commercializing a product that could
compete with such Licensed Product in such country or region, either through (a)
a Valid Claim included within a High Point Patent Right Covering such Licensed
Product in such country or region, or (b) data exclusivity rights, orphan drug
designation, or such other rights conferred by a Regulatory Authority or other
applicable Governmental Authority in such country or region.

1.46. “Licensed Product”. Licensed Product means any pharmaceutical preparation
containing a Program Molecule, including any Combination Product.

1.47. “Losses”. Losses means any and all (a) claims, losses, liabilities,
damages, fines, royalties, governmental penalties, deficiencies, interest,
awards, and judgments, (b) with respect to Third Parties, settlement amounts and
all of the items referred to in clause (a), and (c) in connection with all of
the items referred to in clauses (a) and (b) above, any and all costs and
expenses (including reasonable attorney fees and all other out-of-pocket
expenses reasonably incurred in investigating, preparing or defending any
litigation or proceeding, commenced or threatened).

 

- 4 -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

1.48. “Major EU Country”. Major EU Country means France, Germany, Italy, Spain
or the United Kingdom.

1.49. “Major Markets”. Major Markets means, collectively, the United States, the
Major EU Countries and Japan, and Major Market means any one of them.

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

1.51. “Marketing Authorization”. Marketing Authorization means the act of a
Regulatory Authority or other Governmental Authority necessary for the marketing
and sale of a Licensed Product in a particular Indication or Indications in a
country in the Territory, including, (a) in the case of the United States, the
granting of Regulatory Approval, and, (b) in the case of a country in the
Territory other than the United States in which Pricing Approval is required,
the granting of both Regulatory Approval and Pricing Approval by the applicable
Regulatory Authority or other Governmental Authority in such country. As used in
this definition, “Pricing Approval” means the approval or governmental decision
establishing a price for a Licensed Product that can be charged to consumers and
will be reimbursed by the applicable Governmental Authority(ies) in such
country.

1.52. “MHLW”. MHLW means the Japanese Ministry of Health, Labour and Welfare and
any successor agency thereto.

1.53. “NDA”. NDA means a New Drug Application, as the case may be, as defined in
the Act, filed with the FDA with respect to a Licensed Product, or an equivalent
application filed with the Regulatory Authority of a country in the Territory
other than the United States.

1.54. “Net Sales”. Net Sales means the gross amounts invoiced (or, in the
absence of an invoice, received) by Calithera, its Affiliates and Sublicensees
(each, a “Selling Party”) to any Third Party that is not a Sublicensee with
respect to sales of Licensed Products in the Territory, calculated in the same
manner as reported in its audited financial statements, less the sum of the
following to the extent attributable to such sales:

(a) Discounts, credits, refunds, adjustments, retroactive price reductions,
chargebacks and rebates actually allowed by Calithera, its Affiliates or their
Sublicensees directly for a Licensed Product, including those granted to managed
healthcare organizations, institutions or other buying groups, providers of
healthcare or social and welfare systems;

(b) Sales, import, export, customs, value added taxes, tariffs, duties and other
governmental charges and fees (including annual fees due under Section 9008 of
the United States Patient Protection and Affordable Care Act of 2010 (Pub. L.
No. 111-148)) directly imposed on the Licensed Products without reimbursement
from any Third Party;

(c) Freight and insurance costs actually incurred by Calithera, its Affiliates
or their Sublicensees directly on outbound shipping of Licensed Products;

(d) Amounts actually allowed or credited on rejections or returns of sales of
Licensed Products by Calithera, its Affiliates or their Sublicensees, including
returns by reason of a recall or corrective action;

(e) Amounts paid or credited to customers or third party distributors for
inventory management, distribution, warehousing, and related services to the
extent consistent with industry standards;

(f) arm’s-length fees paid to Third Party consignees or agents in connection
with the sale of the Licensed Product; and

(g) Amounts previously included in Net Sales of such Licensed Product that are
written-off by Calithera, its Affiliates or Sublicensees as uncollectible in
accordance with GAAP.

Even if there is an overlap between any of the deductions described in (a)
through (g) above, each individual item shall only be deducted once in the
overall Net Sales calculation.

Net Sales shall be determined from books and records maintained in accordance
with GAAP, consistently applied throughout the organization and across all
products of the entity whose sales of Licensed Product are giving rise to Net
Sales. Licensed Products transferred for use in clinical or non-clinical
research and trials shall be excluded from Net Sales. Licensed Products sold or
transferred in connection with compassionate sales or use or indigent programs
and Licensed Product samples shall not be counted

 

- 5 -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

toward Net Sales to the extent that such Licensed Products are sold or
transferred at or below fully burdened manufacturing and distribution costs.
Licensed Products transferred between Selling Parties shall not count toward Net
Sales unless such Selling Party is an end-user of such Licensed Product.

In the event that Program Molecules are sold or otherwise commercially disposed
of as part of Combination Products, the Net Sales of such Combination Products,
for purposes of determining royalty payments, shall be determined, as to each
unit of Combination Product sold or otherwise disposed of, by multiplying (x)
the Net Sales of the Combination Product (determined according to the method set
forth above in this Section 1.54) and (y) the Applicable Fraction determined in
accordance with the following:

(i) Except as otherwise set forth in this Section 1.54, the “Applicable
Fraction” shall be A/(A+B), where A is the average wholesale price of the
Product containing such Program Molecule as its only active ingredient when sold
separately in finished form and B is the average wholesale price of the other
product containing Other API and not the Program Molecule (the “Other Product”)
sold separately in finished form.

(ii) In the event that the average wholesale price of the Licensed Product
containing such Program Molecule as its only active ingredient when sold
separately in finished form can be determined but the average wholesale price of
the Other Product when sold separately in finished form cannot be determined,
the “Applicable Fraction” shall be A/C, where A is the average wholesale price
of the Licensed Product containing such Program Molecule when sold separately in
finished form and C is the average wholesale price of the Combination Product.

(iii) In the event that the average wholesale price of the Other Product when
sold separately in finished form can be determined but the average wholesale
price of the Licensed Product containing such Program Molecule as its only
active ingredient when sold separately in finished form cannot be determined,
the “Applicable Fraction” shall be (C-D)/C, where D is the average wholesale
price of the Other Product when sold separately in finished form and C is the
average wholesale price of the Combination Product.

(iv) In the event that the average wholesale price of neither the Licensed
Product containing such Program Molecule as its only active ingredient when sold
separately in finished form nor the Other Product when sold separately in
finished form can be determined, the “Applicable Fraction” shall be F/(F+G),
where F is the fair market value of the Licensed Product containing such Program
Molecule as its only active ingredient contained in the Combination Product and
G is the fair market value of all Other APIs contained in the Combination
Product, as reasonably determined in good faith by the Parties.

1.55. “Objective Response”. Objective Response means the demonstration of [*] or
[*] or [*] or [*] or [*]. For the purposes of this Section 1.55, [*] will be
based on [*] and [*] and [*]. For the avoidance of doubt, any [*], or [*] will
not be considered to have demonstrated [*] for the purposes of this Section
1.55.

1.56. “Party”. Party means either HPP or TransTech, on the one hand or
Calithera, on the other hand; “Parties” means both HPP and TransTech, on the one
hand and Calithera, on the other hand.

1.57. “Patent Rights”. Patent Rights means the rights and interest in and to all
issued patents and pending patent applications in any country in the Territory,
including all provisionals, divisionals, continuations, renewals,
continuations-in-part, patents of addition, re-examination, supplementary
protection certificates, extensions, registrations or confirmation patents,
restoration of patent terms, letters of patent, and reissues thereof, and
foreign counterparts of the foregoing.

1.58. “Person”. Person means any natural person or any corporation, company,
partnership, joint venture, firm, Governmental Authority or other entity,
including a Party.

1.59. “Phase I Clinical Trial”. Phase I Clinical Trial means a human clinical
trial in any country in the Territory that would satisfy the requirements of 21
C.F.R. § 312.21(a).

1.60. “Phase II Clinical Trial”. Phase II Clinical Trial means a human clinical
trial in any country in the Territory that would satisfy the requirements of 21
C.F.R. § 312.21(b).

1.61. “Phase III Clinical Trial”. Phase III Clinical Trial means a human
clinical trial in any country in the Territory that would satisfy the
requirements of 21 C.F.R. § 312.21(c).

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

1.62. “Program Molecule”. Program Molecule means any (a) High Point Molecule or
(b) Calithera-Derived Molecule.

1.63. “Program Patent Rights”. Program Patent Right means (a) all Patent Rights
that (i) are Controlled by Calithera, (ii) disclose or claim (A) a composition
of matter comprising a Hexokinase Inhibitor, (B) any use, or method of making of
any compound or molecule described in subsection (A), or (C) inventions,
results, biomarkers, assays or formulations related exclusively to Hexokinase
Inhibitors or the use or testing, and (iii) are (A) conceived during the Covered
Period by or on behalf of Calithera or any of its Sublicensees, or (B)
in-licensed by Calithera or any of its Sublicensees from a Third Party during
any portion of the Covered Period that is during the Term; and (b) Calithera’s
interest in the Joint Patents. Notwithstanding the foregoing, Program Patent
Rights exclude all Patent Rights conceived by or on behalf of any Sublicensee
prior to the Effective Date or after termination or expiration of the applicable
sublicense.

1.64. “Regulatory Approval”. Regulatory Approval means the granting, whether
through lapse of time or otherwise, by the FDA or by a comparable Regulatory
Authority of approval to market a drug product in a country in the Territory.

1.65. “Regulatory Authority”. Regulatory Authority means any Governmental
Authority, including the FDA, EMA or MHLW, with responsibility for granting
licenses or approvals (with the exception of price approvals) necessary for the
marketing and sale of pharmaceutical products in any country.

1.66. “Research Plan”. Research Plan means the written plan generally describing
the activities to be conducted by or on behalf of High Point pursuant to the
Research Program. The initial Research Plan is attached hereto as Schedule 1.66,
which may be amended from time to time as provided in Section 3.1.

1.67. “Research Program”. Research Program means the conduct of the research
activities described in the Research Plan by or on behalf of High Point.

1.68. “Research Program Term”. Research Program Term means the twelve (12) month
period commencing on the Effective Date and ending twelve (12) months after the
Effective Date, unless earlier terminated pursuant to this Agreement. Calithera
may discontinue the Research Program, for any reason, with at least two months
written notice. In no event will the Research Program extend beyond twelve (12)
months from the Effective Date without mutual agreement.

1.69. “ROW”. ROW means all countries in the Territory other than the countries
in the Major Markets.

1.70. “Small Molecule”. Small Molecule means any organic compound or molecule
with a molecular weight less than three thousand (3000) atomic mass units, other
than a protein or an antibody, but including peptides, peptide analogs,
metabolites, prodrugs, solvates, hydrates, esters, salts, isomers,
stereoisomers, racemates, tautomers, and polymorphs thereof. A “protein” refers
to a sequence of ten (10) or more amino acids joined to each other by peptide
bonds or modified peptide bonds.

1.71. “Sublicensee”. Sublicensee means a Third Party that has been granted a
sublicense under the rights granted to Calithera pursuant to Section 2.1 of this
Agreement, which rights include at least the rights to Develop a Licensed
Product or to Manufacture or Commercialize a Licensed Product. Third Parties
that are permitted only to (a) distribute and resell a Licensed Product, (b)
re-package a Licensed Product for resale or (c) Manufacture a Licensed Product
for supply to Calithera, its Affiliates or its Sublicensees (and have no other
rights to Develop or Commercialize such Licensed Product) are not
“Sublicensees”.

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

1.73. “Third Party”. Third Party means any Person other than High Point or
Calithera or any of their respective Affiliates.

1.74. “Valid Claim”. Valid Claim means a claim in the High Point Patent Rights
that Covers the applicable Licensed Product in a country and that has not (a)
expired; (b) been disclaimed; (c) been cancelled or superseded, or if cancelled
or superseded, has been reinstated; (d) been revoked, held invalid, or otherwise
declared unenforceable or not allowable by a tribunal or patent authority of
competent jurisdiction over such claim in such country from which no further
appeal has or may be taken; and (e) in the case of a patent application, been
pending for more than [*] after the date of its first priority filing.

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

1.75. Additional Definitions. Each of the following definitions is set forth in
the section of this Agreement indicated below:

 

Definition:

Section:

1934 Act

Section 9.4

Abandoned Calithera Patent

Section 12.5(e)(v)

Abandoned Joint Patent

Section 8.2(c)

Abandoned Patent

Section 8.2(b)

Additional Territories

Section 8.2(b)

Agents

Section 9.1

Applicable Fraction

Section 1.54

Assignor

Section 13.9

Calithera

Preamble

Calithera Parties

Section 11.2

Calithera Sole Inventions

Section 8.1(a)

Commercialization Plan

Section 5.2

Confidential Information

Section 9.2

Confidentiality Agreements

Section 9.2

Courts

Section 13.2

Defaulting Party

Section 12.3

Development Forum or DF

Section 4.2(a)

Effective Date

Preamble

High Point

Preamble

High Point Parties

Section 11.1

High Point Sole Inventions

Section 8.1(a)

HPP

Preamble

House Marks

Section 12.5(f)

Indemnified Party

Section 11.3(a)

Indemnifying Party

Section 11.3(a)

Infringement Claim

Section 8.3(a)

Joint Inventions

Section 8.1(b)

Joint Patents

Section 8.2(c)

Other API

Section 1.12

Other Product

Section 1.54

Paragraph IV Claim

Section 8.8(a)

Quarterly Research Fee

Section 7.2(a)

Research Program Coordinator

Section 3.3

Royalty Term

Section 7.6(e)

Sole Inventions

Section 8.1(a)

Term

Section 12.1

Third Party Claims

Section 11.1

Third Party Licenses

Section 7.6(d)

TransTech

Preamble

Unelected Patent

Section 8.2(b)

 

 

- 8 -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

ARTICLE II.

GRANTS OF RIGHTS

2.1. High Point Grants of Rights.

(a) License Grant. Subject to the terms and conditions of this Agreement, High
Point hereby grants to Calithera an exclusive (even as to High Point and its
Affiliates, except as set forth in Section 2.2(a)), royalty-bearing right and
license, under the High Point Intellectual Property, to (i) Manufacture and use
High Point Molecules to identify and synthesize Calithera-Derived Molecules,
(ii) Develop High Point Molecules and Calithera-Derived Molecules into Licensed
Products, and (iii) make and have made, use, offer for sale, sell, have sold,
import and otherwise Commercialize or have Commercialized Program Molecules and
Licensed Products in the Field in the Territory; subject to Section 2.2(a).

(b) Sublicenses. Calithera shall have the right to grant sublicenses through
multiple tiers under the licenses granted to Calithera under Section 2.1(a) to
its Affiliates and to Third Parties without High Point’s prior written approval
but with written notice to High Point, with such notice to be provided no later
than ninety (90) days after the grant of each sublicense. Calithera shall
provide High Point with written notice of the termination or expiration of any
sublicense granted to a Third Party within thirty (30) days thereof. All
sublicenses granted by Calithera hereunder shall be consistent with the terms
and conditions of this Agreement. Calithera shall remain liable for breaches by
its Sublicensees of any sublicense agreement; provided that in the event a
breach by a Sublicensee under its sublicense causes Calithera to breach any of
its obligations under this Agreement, Calithera shall have the opportunity to
cure as set forth in Section 12.3.

2.2. Calithera Grants of Rights.

(a) License Grant. Subject to the terms and conditions of this Agreement,
Calithera hereby grants to High Point a non-exclusive, royalty-free right and
license, with the limited right to sublicense and to have made as set forth in
Section 2.2(b), under the Calithera Intellectual Property and its rights under
the High Point Intellectual Property as set forth in Section 2.1(a), solely to
conduct, on behalf of Calithera, High Point’s research responsibilities under
the Research Program.

(b) Sublicenses. High Point shall have the right to grant sublicenses under the
license granted to High Point under Section 2.2(a), to other Persons retained by
High Point upon the prior written consent of Calithera, such consent not to be
unreasonably withheld, delayed or conditioned, in each case solely to perform
High Point’s responsibilities under the Research Program on High Point’s behalf.
All permitted sublicenses of High Point hereunder shall include terms and
covenants at least as favorable to and for the benefit of Calithera as those
provided by High Point in the following sections of this Agreement: Sections
2.2(b), 8.1(d), 9, 10.1(b) and 10.1(c). High Point shall remain liable for
breaches by its sublicensees of any sublicense agreement; provided that in the
event a breach by such sublicensee under its sublicense causes High Point to
breach any of its obligations under this Agreement, High Point shall have the
opportunity to cure as set forth in Section 12.3.

2.3. Rights Retained by the Parties. Any rights of High Point or Calithera, as
the case may be, not expressly granted to the other Party under the provisions
of this Agreement shall be retained by such Party, subject to Section 2.5.
Without limiting the generality of the foregoing and without limitation to
Section 2.5, no right or license is granted under the High Point Intellectual
Property to access or use any compound or molecule that is not a Program
Molecule.

2.4. Section 365(n) of the Bankruptcy Code. All rights and licenses granted
under or pursuant to any Section of this Agreement, including under Sections 2.1
and 2.2, are rights to “intellectual property” (as defined in Section 101(35A)
of the Bankruptcy Code). Each of High Point and Calithera hereby acknowledges
that (a) copies of research data, (b) laboratory samples, (d) product samples,
(d) formulas, (e) laboratory notes and notebooks, (f) data and results related
to clinical trials, (g) regulatory filings and approvals, (h) rights of
reference in respect of regulatory filings and approvals, (i) pre-clinical
research data and results, and (j) marketing, advertising and promotional
materials, in each case that relate to such intellectual property, constitute
“embodiments” of such intellectual property pursuant to Section 365(n) of the
Bankruptcy Code. Each Party shall retain and may fully exercise all of its
rights and elections under the Bankruptcy Code or equivalent legislation in any
other jurisdiction. Upon the bankruptcy of either Party, the other Party shall
further be entitled to a complete duplicate of, or complete access to, as
appropriate, any such intellectual property, and such intellectual property, if
not already in its possession, shall be promptly delivered to such other Party,
unless the Party in bankruptcy elects to continue, and continues, to perform all
of its obligations under this Agreement.

2.5. Exclusivity. During the Term, neither High Point nor any of its controlled
(as such word is defined in Section 1.2) Affiliates shall, alone or in
collaboration with any other Person, [*]. During the Term, High Point shall
ensure that none of its personnel or its controlled (as such word is defined in
Section 1.2) Affiliates’ or their personnel (a) enable or assist any other
Affiliate of High Point or

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

any Third Party with [*] or (b) disclose any Confidential Information relating
to Hexokinase Inhibitors to any Affiliate of High Point other than a controlled
(as such word is defined in Section 1.2) Affiliate or an investor in High Point
that is subject to obligations of non-disclosure and non-use with respect
thereto.

ARTICLE III.

RESEARCH

3.1. General. Calithera shall lead, and pay all costs of, the research of
Licensed Products in the Field in the Territory hereunder. High Point shall use
commercially reasonable efforts to perform the Research Program in accordance
with the Research Plan. The Research Plan may be amended from time to time by
mutual agreement of the Parties.

3.2. High Point FTE Commitments.

(a) During the first twelve (12) months of the Research Program Term, High Point
shall provide [*] to four (4) FTEs to work on the Research Program consistent
with the timelines set forth in the Research Plan and Calithera shall fully fund
the costs of such FTEs at the FTE Rate as provided in Section 7.2. In no event
shall Calithera be responsible for funding more than four (4) FTEs per year.
High Point shall be responsible for and shall provide sufficient resources,
including reagents and disposables, at High Point’s cost and expense, to
complete all aspects of the Research Plan assigned to High Point, including
synthesizing any additional High Point Molecules; provided, however, that,
except as set forth in the initial Research Plan attached hereto as Schedule
1.64, High Point shall not be obligated to manufacture quantities of any Program
Molecule beyond the quantity needed for research purposes, which shall not
exceed the greater of the amounts listed in the initial Research Plan or [*] of
each Program Molecule.

(b) High Point shall require by written agreement that all FTEs and all other
High Point personnel, employees, and agents involved in the Research Program
have entered into confidentiality and invention assignment agreements that are
consistent with the provisions of this Agreement and shall be obligated to
assign any rights they may have in any invention made during such work to High
Point.

3.3. Research Program Coordinators. Calithera and High Point each shall appoint
a representative (each, a “Research Program Coordinator”) to serve as the
primary contact between the Parties with respect to the Research Program. Each
Party shall notify the other within thirty (30) days after the Effective Date of
the appointment of its Research Program Coordinator and shall notify the other
Party as soon as practicable upon changing this appointment. The Research
Program Coordinators shall meet at least once per month during the Research
Program Term or more frequently as agreed by the Parties to discuss the progress
of the Research Program and interim results. Such meetings may be by
teleconference or in person, with each Party responsible for its own travel
expenses, at a location agreed by the Parties. Within thirty (30) days after the
end of the first three (3) months of the Research Program Term, and within
thirty (30) days after the end of each three (3) month period thereafter, High
Point’s Research Program Coordinator shall provide a written report to
Calithera’s Research Program Coordinator summarizing the status and interim
results of the Research Program.

3.4. Calithera Contributions. Upon the reasonable request of High Point,
Calithera may, but shall not be obligated to, provide High Point with
scientific, development or other expertise in connection with the performance by
High Point of its responsibilities under the Research Plan.

3.5. High Point Assistance. During the [*] month period immediately following
the Effective Date and again during the [*] month period immediately following
the Research Program Term, High Point shall provide Calithera reasonable
assistance in transitioning High Point’s Hexokinase Inhibitor program to
Calithera at no additional cost other than reimbursement of High Point’s
reasonable related out-of-pocket expenses. High Point shall promptly execute all
reasonable actions following Calithera’s request so as not to delay any
timelines set forth in the Research Plan or the Development Plan. Such
assistance shall include providing Calithera with copies of all tangible
materials in High Point’s possession that are included in the High Point
Intellectual Property or that otherwise relate to High Point’s Hexokinase
Inhibitor program (such as cancer cell lines and assays), subject to High
Point’s existing obligations to any applicable Third Party, and related
information regarding High Point’s Hexokinase Inhibitor program, and providing
reasonable amounts of consultation regarding such materials and information and
the status of High Point’s Hexokinase Inhibitor program.

 

- 10 -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

ARTICLE IV.

DEVELOPMENT

4.1. General. Subject to the terms of this Agreement, including the requirements
of ARTICLE VI, Calithera shall be solely responsible for, and pay all costs of,
the Development of Program Molecules and Licensed Products in the Field in the
Territory, and for Manufacture of all Program Molecules and Licensed Products to
support such Development, and shall use Commercially Reasonable Efforts to
perform such Development in accordance with the Development Plan. Calithera will
provide High Point with a summary clinical Development Plan for the Program
Molecules and Licensed Products prepared at least annually and updated as
appropriate; such plans may be redacted for proprietary information as well as
information that is not relevant to Program Molecules or Licensed Products.

4.2. Development Forum. The Parties hereby establish a forum for communications
and discussions regarding the Development Plan (the “Development Forum” or
“DF”).

(a) Composition of the Development Forum. The Development Forum shall be
comprised of an equal number of representatives of each Party which, unless the
Parties otherwise agree, shall be two (2) representatives of each Party. Each
Party shall notify the other within thirty (30) days after the Effective Date of
the appointment of its representatives to the DF, which representative shall
have the requisite technical knowledge and experience to oversee Development of
Program Molecules and Licensed Products and the requisite seniority to make
decisions regarding such Development on behalf of such Party. Each Party may
change its representatives to the DF from time to time in its sole discretion,
effective upon notice to the other Party of such change. These representatives
shall have ongoing familiarity with and a technical understanding of the
Development Plan activities. Additional representatives or consultants may from
time to time, by mutual consent of the Parties, be invited to attend DF
meetings. The DF shall be chaired by a representative of Calithera. Each Party
shall bear its own expenses related to the attendance of such meetings by its
representatives.

(b) Meetings. The DF shall meet in accordance with a schedule established by
mutual written agreement of the Parties or upon the reasonable request of
Calithera, but no less frequently than [*] during the Development Term, with the
location for such meetings alternating between High Point and Calithera
facilities in the United States (or such other location as may be agreed by the
Parties), with each Party paying for its own travel expenses. Alternatively, the
DF may meet by means of teleconference, videoconference or other similar
communications equipment as the Parties may agree.

(c) Scope of Development Forum. The DF’s role shall be limited to communications
and discussions regarding the Development of Program Molecules and Licensed
Products in the Field. Within such scope the DF may: (i) confer regarding the
status of Development Plan activities; (ii) review and discuss amendments to the
Development Plan; and (iii) discuss such other matters relating to the
Development of Program Molecules and Licensed Products in the Field as either
Party may bring before the DF. The DF shall have no decision-making authority.

4.3. Exchange of Information Regarding Development. During the Development Term,
Calithera shall provide High Point, through the DF, with information and data
relating to Calithera’s Development of Program Molecules and Licensed Products
in the Field. In addition, Calithera shall, promptly upon request by High Point,
provide High Point with additional information reasonably requested by High
Point relating to Calithera’s Development of Program Molecules and Licensed
Products in the Field. Without limiting the generality of the foregoing, at
least [*] during the period after the Development Term for so long as Calithera
continues to Develop any Program Molecule or Licensed Product for an Indication
(other than the Indication(s) for which the applicable Licensed Product has
received Regulatory Approval), Calithera shall provide High Point with a
reasonably detailed report describing Calithera’s Development activities and the
summary results thereof with respect to all Program Molecules and Licensed
Products. Notwithstanding anything to the contrary, this Section 4.3 shall be
subject in all respects to ARTICLE IX.

ARTICLE V.

COMMERCIALIZATION

5.1. General. Subject to the terms of this Agreement, including the requirements
of ARTICLE VI, Calithera shall be solely responsible for, and pay all costs of,
the Commercialization of Licensed Products in the Field in the Territory, and
for Manufacture of all Licensed Products to support such Commercialization.

5.2. Commercialization Plans. During the Royalty Term with respect to each
Licensed Product, Calithera shall provide High Point at least once per year with
a summary of the Commercialization activities to be conducted by or on behalf of
Calithera and its

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

Affiliates and Sublicensees (to the extent known to Calithera) with respect to
such Licensed Product in the Major Markets, taken as a whole, during the next
year (each such plan, a “Commercialization Plan”).

ARTICLE VI.

DILIGENCE

6.1. Commercially Reasonable Efforts. During the Term, subject to Section 6.3,
Calithera shall use Commercially Reasonable Efforts to research, Develop, seek
Marketing Authorizations for, Manufacture and Commercialize at least one Program
Molecule and Licensed Product in the Territory.

6.2. Specific Efforts with Respect to Program Molecules and Licensed Products.
Subject to Section 6.3, Calithera shall achieve [*], by the corresponding
deadlines (subject to Section 13.11) with respect to at least one Program
Molecule or Licensed Product set forth in the table below:

 

Diligence Milestone

Deadline

 

[*]

 

[*]

 

* For purposes of (b) above, [*] means a [*] that:

[*]

For clarity, Calithera shall not be deemed to be in breach of its obligations
under this Section 6.2 for failure to meet a diligence milestone by the
applicable deadline if (A) such deadline has been extended pursuant to Section
6.3, (B) Calithera can demonstrate to High Point’s reasonable satisfaction that
Calithera is actively pursuing ongoing studies designed to achieve such
diligence milestone by such extended deadline, and (C) Calithera achieves such
diligence milestone by such extended deadline (which may be subject to further
extension pursuant to Section 6.3).

6.3. Failure to Meet Diligence Obligations. If Calithera fails to meet its
obligations under Section 6.1 or 6.2 in any material respect, then High Point
shall notify Calithera of such failure and High Point shall have the right to
terminate this Agreement pursuant to Section 12.3 (subject to the opportunity to
cure as set forth therein) in the case of a breach under Section 6.1 or Section
6.2. Notwithstanding the foregoing, if such failure is due to causes that are
beyond the reasonable control of Calithera, including due to regulatory action
or delay, low patient enrollment, safety concerns, issues with chemistry,
manufacturing and controls (CMC), force majeure, delays due to an institutional
review board, scientific or legal reasons or delays caused by High Point, its
Affiliates or a Third Party, notwithstanding Calithera’s good faith efforts to
achieve those milestones, then, if Calithera promptly notifies High Point in
writing of any such delay and the cause and anticipated duration thereof,
Calithera not be deemed in default or breach of this Agreement and the deadlines
for achieving those milestones will be deemed automatically extended by the time
of the delay reasonably attributable to such applicable causes.

ARTICLE VII.

FINANCIAL PROVISIONS

7.1. Initial License Payment. Calithera shall make a one-time payment to HPP of
Six Hundred Thousand Dollars ($600,000) no later than thirty (30) days after the
Effective Date as upfront consideration for the license granted hereunder.

7.2. Research Program. On or prior to the fifth (5th) Business Day after the end
of the first Calendar Quarter following the Effective Date, HPP shall submit an
invoice and Calithera shall pay HPP within twenty-five (25) days after receipt
of such invoice, a Quarterly Research Fee for the then-ended first Calendar
Quarter of the Research Program Term or portion thereof, as applicable.
Thereafter, on the last day of each Calendar Quarter during the portion of the
Research Program Term covered by the Research Plan, HPP shall submit an invoice,
and Calithera shall pay HPP within twenty-five (25) days after receipt of such
invoice, a Quarterly Research Fee for such Calendar Quarter of the Research
Program Term. As used in this Agreement, “Quarterly Research Fee” means the
amount determined by multiplying the FTE Rate by the number of FTE hours to be
contributed by High Point pursuant to the Research Plan during the applicable
Calendar Quarter or portion thereof of the Research Program Term. For purposes
of clarity, the maximum amounts payable by Calithera to HPP for FTEs annually,
if High Point provides the maximum of four (4) FTEs, is set forth in Schedule
7.2(a) and the minimum amounts payable by Calithera to HPP annually, if High
Point provides the minimum of [*] FTEs,

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

is set forth in Schedule 7.2(b). The minimum and maximum Quarterly Research Fee
for each Calendar Quarter of the Research Program Term is set forth in Schedule
7.2(c).

7.3. Development, Manufacturing and Commercialization Costs. As between the
Parties, Calithera shall be solely responsible for all costs of Developing,
Manufacturing and Commercializing Licensed Products.

7.4. Event Milestone Payments. Calithera shall make the non-refundable,
non-creditable payments to HPP set forth below not later than thirty (30) days
after the earliest date on which the corresponding milestone event set forth
below is first achieved by a Licensed Product for a disease or condition in the
Field:

 

Milestone Event

Payment

(a)[*]

$[*]

(b)[*]

$[*]

(c)[*]

$[*]

(d)[*]

(i) $[*]

(ii) $[*]

(iii) $[*]

(e)[*]

$[*]

(f)[*]

$[*]

(g)[*]

$[*]

(h)[*]

$[*]

(i)[*]

$[*]

(j)[*]

$[*]

(k)[*]

$[*]

(l)[*]

$[*]

(m)[*]

$[*]

 

For purposes of clarity, the milestone payments set forth in this Section 7.4
shall be paid only once, upon the first achievement of the applicable milestone
event by the first Licensed Product to achieve such milestone event, except
that, if Regulatory Approval is obtained for a first Licensed Product, and
Calithera or any of its Affiliates or Sublicensees subsequently commence
Development of an additional Licensed Product, then the milestones payments for
each of the milestone events listed in Section 7.4(f) ([*]) through (m) ([*])
above shall be payable at [*] of the corresponding milestone payment amount for
the first subsequent Licensed Product that achieves such milestone event. For
purposes of clarity, the maximum potential payment by Calithera under this
Section 7.4 for each milestone shall be one hundred percent (100%) of each
milestone payment set forth in (a) though (e) and [*] of each milestone payment
set forth in (f) through (m) (i.e., one hundred percent (100%) for the first
Licensed Product to achieve such milestone and an additional [*] for the second
Licensed Product to achieve such milestone).

If, with respect to any particular Licensed Product, a later-listed milestone
event in Section 7.4 (other than milestone (d) and each of the milestones (h)
through (m), namely the [*] for additional Indication milestones) is achieved by
such Licensed Product prior to the achievement by such Licensed Product of an
earlier-listed milestone event in Section 7.4 (other than milestone (d) and each
of the milestones (h) through (m), namely the [*] for additional Indication
milestones), then the milestone payment for such earlier-listed milestone event
for such Licensed Product shall be due and payable simultaneously with the
payment for achievement of such subsequent milestone event, except that (x) [*]
shall not be deemed to trigger any milestone payment [*], and (y) [*] shall not
be deemed to trigger any other milestone payment.

If Calithera elects to cease Development of any Licensed Product, then the
milestone payments previously made by Calithera under this Section 7.4 shall be
fully creditable against the achievement of such milestone by a subsequent
Licensed Product.

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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7.5. Sales Milestone Payments. In addition to all other amounts payable under
this Agreement, Calithera shall make non-refundable, non-creditable milestone
payments to HPP related to the marketing and sale of Licensed Products in the
Territory, in the amounts provided below:

 

Milestone Event

Payment

(a) Aggregate Net Sales of a Licensed Product in the Territory of greater than
$[*] in a Calendar Year

$[*]

(b) Aggregate Net Sales of a Licensed Product in the Territory of greater than
$[*] in a Calendar Year

$[*]

(c) Aggregate Net Sales of a Licensed Product in the Territory of greater than
$[*] in a Calendar Year

$[*]

 

For purposes of clarity, each of the milestone payments set forth in this
Section 7.5 shall be paid only once and the maximum potential payment by
Calithera under this Section 7.5 for each milestone shall be equal to one
hundred percent (100%) of each milestone payment. A maximum of one milestone
event specified in Section 7.5(a), (b), and (c) above will be payable by
Calithera for any given Calendar Year. If two or more of such milestone events
are achieved in different Calendar Quarters in the same Calendar Year, then
Calithera shall pay each corresponding milestone payment within the time period
specified in Section 7.7, but may credit any milestone payment previously made
for such Calendar Year against the subsequent milestone payment for the same
Calendar Year, such that, for such subsequent milestone event, Calithera shall
only be obligated to pay the difference between the milestone payment for the
subsequent event and the aggregate of all other sales milestone payments made
during such Calendar Year corresponding to the earlier event(s), and the earlier
milestone payments may become payable if and when achieved in a subsequent
Calendar Year. If two or more of such milestone events are achieved in the same
Calendar Quarter, Calithera shall only be obligated to pay the greater of the
corresponding milestone payments for such Calendar Quarter and the earlier
milestone payments may become payable if and when achieved in a subsequent
Calendar Year.

For example, upon the first achievement of the milestone event set forth in
Section 7.5(a), Calithera shall make the $[*] payment in accordance with Section
7.7. If the milestone event set forth in Section 7.5(b) is also achieved during
the same Calendar Year, Calithera shall make the $[*] payment for that milestone
event in accordance with Section 7.7, but Calithera may credit the $[*] it paid
for achievement of the milestone event set forth in Section 7.5(a) against such
amount resulting in a net payment of $[*]. In this example, each of the
milestone events set forth in Sections 7.5(a) and (c) would become payable in
subsequent Calendar Years if and when it is achieved.

7.6. Licensed Product Royalties. Calithera shall pay to HPP royalties on Net
Sales of Licensed Products in the Territory as follows:

 

Calendar Year Net Sales of Licensed Products

Royalty Rate

Less than or equal to $[*]

[*]%

Greater than $[*] and less than or equal to $[*]

[*]%

Greater than $[*] and less than or equal to $[*]

[*]%

Greater than $[*]

[*]%

 

(a) Applicability of Royalty Rates to Net Sales in the Territory. Royalties
under this Section 7.6 on aggregate Net Sales of Licensed Products in the
Territory in a Calendar Year shall be paid at the rate applicable to the portion
of Net Sales within each of the Net Sales levels during such Calendar Year. For
example, if, during a Calendar Year, aggregate Net Sales of Licensed Products
were equal to $[*], then the royalties payable by Calithera under this Section
7.6 would be calculated by adding (i) the royalties with respect to the first
$[*] at the first‑level percentage of [*] percent ([*]%) ($[*] × [*] = $[*]),
and (ii) the royalties with respect to the next $[*] at the second‑level
percentage of [*] percent ([*]%) ($[*] × [*] = $[*]), for a total royalty of
$[*].

(b) Royalty Term. Calithera’s royalty obligations to HPP under this Section 7.6
shall commence on a country-by-country and Licensed Product-by-Licensed Product
basis upon the First Commercial Sale of such Licensed Product in such country
and shall expire on a country-by-country basis and Licensed Product-by-Licensed
Product basis on the later of: (i) the expiration of Legal Exclusivity for such
Licensed Product in such country (the “Exclusivity Royalty Term”) or (ii) the
tenth (10th) anniversary of the date

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

of the First Commercial Sale by Calithera or any of its Affiliates or
Sublicensees to a non-Sublicensee Third Party of such Licensed Product in such
country (the “Royalty Term”). Upon expiration of the Royalty Term for a given
Licensed Product in a given country, Calithera’s license under Section 2.1(a)
shall become fully paid-up and perpetual with respect to Commercialization of
such Licensed Product in such country.

(c) Royalty Adjustment for Generic Competition or Expiration of Exclusivity
Royalty Term. If, with respect to a particular Licensed Product in a particular
country in a particular Calendar Quarter, the Exclusivity Royalty Term has
expired, then the royalties payable pursuant to this Section 7.6 may be reduced
for such Calendar Quarter to the extent required to comply with applicable Law,
if any, governing royalties payable on Licensed Products after expiration of all
issued High Point Patent Rights Covering such Licensed Products, and provided,
that (i) if the Generic Products have a market share during such Calendar
Quarter of more than [*] and less than or equal to [*] of the aggregate market
share of the corresponding Licensed Product(s) and Generic Product(s) (based on
data provided by IMS International, or if such data is not available, such other
reliable data source as reasonably determined by Calithera and agreed by HPP
(such agreement not to be unreasonably withheld)) as measured by unit sales,
then the royalty rate pursuant to Section 7.6(a) for such Licensed Product(s) in
such country shall be reduced for such Calendar Quarter to [*] of Net Sales, and
(ii) if the Generic Product(s) have a market share of more than [*] (as
calculated in the preceding proviso) during such Calendar Quarter, then [*]
royalty shall be payable under this Section 7.6 on Net Sales during such
Calendar Quarter of such Licensed Product(s) in such country.

(d) Third Party Licenses. If Calithera reasonably determines to obtain a patent
or intellectual property license from a Third Party that is required or
reasonably needed to make, sell or use a Licensed Product in the Field in a
given country (“Third Party License”), then Calithera may offset [*] of any
payments (including upfront payments, milestones and royalties) paid under such
Third Party License to obtain such rights for such Licensed Product in such
country against royalties payable to HPP hereunder in respect of Net Sales of
such Licensed Product in such country; provided, however, in no event shall such
credit cause the royalties paid to HPP for any particular Calendar Quarter to be
reduced to less than [*] of the amount that would otherwise be payable to HPP
for such Calendar Quarter pursuant to Section 7.6 with respect to such Licensed
Product in such country. Notwithstanding the foregoing provisions of this
Section 7.6(d), [*] to the extent any Third Party Licenses relate to [*].

(e) Aggregate Royalty Reductions. Notwithstanding anything to the contrary in
this Section 7.6, in no event shall the royalties otherwise payable under
Section 7.6(a) with respect to any given Net Sales of a Licensed Product in a
country in the Territory be reduced as a result of the royalty reduction
provisions of Sections 7.6(c) and (d) to be less than [*].

7.7. Reports; Payments. Within [*] days after the end of each Calendar Quarter
other than the last Calendar Quarter of Calithera’s fiscal year, and within [*]
days after the end of the last Calendar Quarter of Calithera’s fiscal year, in
which there are Net Sales giving rise to a payment obligation under Section 7.5
or 7.6, Calithera shall submit to HPP a report identifying, for each Licensed
Product, the gross amount of sales of such Licensed Product for each country for
such Calendar Quarter and the resulting royalties and the sales milestone
payable to HPP, including a description of any deductions made from the gross
amount of sales to calculate Net Sales and any royalty reductions made as a
result of Sections 7.6(d) and 7.6(e). Concurrently with each such report,
Calithera shall pay to HPP all royalties and sales milestones payable by it
under Sections 7.5 and 7.6.

7.8. Books and Records; Audit Rights. Calithera shall keep complete and accurate
records of the underlying revenue and expense data relating to the calculations
of Net Sales and payments required by Sections 7.5 and 7.6. HPP shall have the
right, once annually at its own expense, to have an independent, certified
public accounting firm, selected by HPP and reasonably acceptable to Calithera,
review any such records of Calithera in the location(s) where such records are
maintained by Calithera upon reasonable notice (which shall be no less than
thirty (30) days prior notice) and during regular business hours and under
obligations of strict confidence, for the sole purpose of verifying the basis
and accuracy of payments made under Sections 7.5 and 7.6 within the [*] period
preceding the date of the request for review. The report of such accounting firm
shall be limited to a certificate stating whether any report made or payment
submitted by Calithera during such period is accurate or inaccurate and the
actual amounts of Net Sales and royalties due for such period. Calithera shall
receive a copy of each such report concurrently with receipt by HPP. Should such
inspection lead to the discovery of a discrepancy to HPP’s detriment, Calithera
shall pay within fifteen (15) Business Days after its receipt from the
accounting firm of the certificate the amount of the discrepancy. HPP shall pay
the full cost of the review unless the underpayment of royalties is greater than
[*] of the amount due for the applicable period, in which case Calithera shall
pay the reasonable cost charged by such accounting firm for such review. Any
overpayment of royalties by Calithera revealed by an examination shall be fully
creditable against future royalty payments.

7.9. Taxes. HPP shall pay any and all taxes levied on account of all payments it
receives under this Agreement. If laws or regulations require that taxes be
withheld, Calithera will (a) deduct those taxes from the remittable payment, (b)
timely pay the taxes to the proper taxing authority, and (c) send proof of
payment to HPP within thirty (30) days after receipt of confirmation of payment

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

from the relevant taxing authority. Calithera will reasonably cooperate with HPP
to obtain the benefit of any applicable tax law or treaty, including the pursuit
of any refund or credit of such tax to HPP.

7.10. Payment Method and Currency Conversion. All payments to be made by
Calithera to HPP 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 Calithera’s election, to HPP’s bank account at
[*], or to such other bank account as HPP shall designate in a notice at least
ten (10) days before the payment is due. HPP’s wiring instructions are set forth
on Schedule 7.10. For the purposes of determining the amount of any sales
milestone payment under Section 7.5 or royalties due for the relevant Calendar
Quarter under Section 7.6, the amount of Net Sales in any foreign currency shall
be converted into United States dollars in a manner consistent with Calithera’s
normal practices used to prepare its audited financial reports; provided that
such practices use a widely accepted source of published exchange rates. Upon
request by HPP, Calithera shall disclose the source for the rates of exchange
used.

7.11. Blocked Payments. If by reason of applicable Laws in any country in the
Territory, it becomes impossible or illegal for Calithera or its Affiliates or
Sublicensees to transfer, or have transferred on its behalf, milestones,
royalties or other payments to HPP, Calithera shall promptly notify HPP of the
conditions preventing such transfer and such milestones, royalties or other
payments shall be deposited in local currency in the relevant country to the
credit of HPP in a recognized banking institution designated by HPP or, if none
is designated by HPP within a period of thirty (30) days, in a recognized
banking institution selected by Calithera or its Affiliate or Sublicensee, as
the case may be, and identified in a notice given to HPP. If so deposited in a
foreign country, Calithera shall provide, or cause its Affiliate or Sublicensee
to provide, reasonable cooperation to HPP so as to allow HPP to assume control
over such deposit as promptly as practicable.

7.12. Late Payments. If a Party shall fail to make a timely payment pursuant to
the terms of this Agreement, interest shall accrue on the past due amount as
follows:

(a) for amounts thirty (30) or fewer days past due, the rate applied shall be
the thirty (30) day U.S. dollar LIBOR rate effective for the date that payment
was due (as published in the Wall Street Journal), computed for the actual
number of days the payment was past due; and

(b) for amounts greater than thirty (30) days past due, the rate applied shall
be the thirty (30) day U.S. dollar LIBOR rate effective for the date that
payment was due (as published in the Wall Street Journal) plus [*] per annum,
computed for the actual number of days the payment was past due.

ARTICLE VIII.

INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION

AND RELATED MATTERS

8.1. Ownership of Inventions.

(a) Sole Inventions. Each Party shall exclusively own all inventions made solely
by such Party, its employees, agents and consultants (“Sole Inventions”). Sole
Inventions made solely by Calithera, its employees, agents and consultants are
referred to herein as “Calithera Sole Inventions”. Sole Inventions made solely
by High Point, its employees, agents and consultants shall be solely owned by
HPP and are referred to herein as “High Point Sole Inventions”.

(b) Joint Inventions. Calithera and HPP shall jointly own all inventions made
jointly by employees, agents and consultants of Calithera, on the one hand, and
employees, agents and consultants of High Point, on the other hand, on the basis
of each of Calithera and HPP having one-half of an undivided interest in the
whole (“Joint Inventions”). Each Party, on behalf of itself and its Affiliates
and permitted sublicensees, hereby assigns, agrees to assign or causes to be
assigned sufficient of its and its Affiliates’ and its permitted sublicensees’
right, title and interest in, to and under any Joint Invention as necessary to
effect the foregoing joint ownership allocation or any other assignment or
license obligation under this Agreement with respect to such Joint Invention.
HPP hereby acknowledges and agrees that all of its right, title and interest in,
to and under Joint Inventions shall become part of the High Point Intellectual
Property and subject to the license set forth in Section 2.1(a).

(c) Inventorship. For purposes of determining whether an invention is a
Calithera Sole Invention, a High Point Sole Invention or a Joint Invention, and
for purposes of determining inventions with respect to Program Patent Rights,
questions of inventorship shall be resolved in accordance with United States
patent Laws.

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

(d) Further Assurances. Each Party shall, and shall cause its Affiliates and
permitted sublicensees to, enter into assignment agreements pre-approved and
reasonably acceptable to the other Party with Persons involved in the Research
Program to obtain such automatic assignment of future inventions, and shall
execute all documents necessary to effect such assignment.

8.2. Prosecution and Maintenance of Patent Rights.

(a) Prosecution of Calithera Patent Rights. Except as set forth in Section
12.5(e)(iv), Calithera shall have the sole right to prepare, file, prosecute and
maintain the Calithera Patent Rights (including the Program Patent Rights) other
than the Joint Patents.

(b) Prosecution of High Point Patent Rights. In accordance with this Section
8.2(b), unless Calithera and HPP otherwise agree in writing and for so long as
Calithera retains exclusive rights hereunder, Calithera shall have the right,
but not the obligation, and High Point shall reasonably cooperate, with respect
to, the preparation, filing, prosecution and maintenance of the High Point
Patent Rights (other than the Joint Patents), using Foley Hoag LLP or other
counsel of Calithera’s choice reasonably acceptable to HPP. The out-of-pocket
costs and expenses incurred to prepare, file, prosecute and maintain such High
Point Patent Rights shall be [*]. Calithera shall notify HPP at least forty-five
(45) days prior to the deadline for entering into national phase with respect to
any PCT application included in such High Point Patent Rights and identify the
countries or regions Calithera intends to enter. No later than fifteen (15) days
after receiving notice from Calithera of its intent to enter into national
phase, HPP shall provide Calithera with a list of any additional countries or
regions (“Additional Territories”) in which HPP would like Calithera to file and
Calithera shall consider such list in good faith. If Calithera elects to not
enter the national phase in one or more Additional Territories, HPP may elect to
enter the national phase in such Additional Territories [*], any such
application or patent (the “Unelected Patent”) shall [*], and HPP shall have the
sole right, but not the obligation, to prepare, file, prosecute and maintain
such Unelected Patent.

HPP shall have access to all documentation, filings and communications to or
from the respective patent offices, at reasonable times and upon reasonable
written notice (which notice may be in e-mail). Calithera shall keep HPP
informed of the status of all pending patent applications that pertain to any
Program Molecule or any Licensed Product. Calithera, its agents and attorneys
shall consider in good faith comments of HPP regarding any aspect of such patent
prosecutions. In the event that HPP believes that such patent strategy would
have an unreasonable, adverse, economic effect on High Point’s rights under this
Agreement (including inventorship or the value of any rights that HPP may obtain
under Section 12.5), HPP may elect to submit the dispute to an independent Third
Party patent counsel mutually agreed by Calithera and HPP, at HPP’s cost and
expense. If such patent counsel determines that such patent strategy would have
an unreasonable, adverse economic effect on High Point’s rights under this
Agreement (including inventorship or the value of any rights that HPP may obtain
under Section 12.5), then Calithera shall incorporate comments and adjust patent
strategy as advised by such independent Third Party patent counsel, and
Calithera shall [*]. If Calithera determines to abandon any High Point Patent
Right (other than a Joint Patent) in all or any portion of the Territory (the
“Abandoned Patent”), Calithera shall notify HPP of such determination, no later
than thirty (30) days before any deadline for further action to avoid
abandonment. If HPP wishes to continue to prosecute and maintain the Abandoned
Patent, Calithera shall have the option to continue to prosecute and maintain
the Abandoned Patent or allow HPP to have the sole right, but not the
obligation, to continue to prosecute and maintain the Abandoned Patent [*],
which for purposes of clarity, shall [*] set forth in this Agreement. If HPP is
prosecuting and maintaining the Abandoned Patent and High Point determines to
abandon such Abandoned Patent, the foregoing rights of HPP set forth in this
Section 8.2(a) shall apply to Calithera mutatis mutandis. Notwithstanding
anything to the contrary, Calithera shall have the option to regain control of
prosecution and maintenance of an Abandoned Patent at any time, subject to [*]
and [*] for such Abandoned Patent. If either Calithera or HPP elects to maintain
any Abandoned Patent or Unelected Patent, the other shall reasonably cooperate
to transfer such maintenance and prosecution thereof.

(c) Prosecution of Joint Patents. Calithera shall be responsible for obtaining,
preparing, filing, prosecuting and maintaining Patent Rights, in appropriate
countries in the Territory, including the countries reasonably requested by HPP,
Covering Joint Inventions (“Joint Patents”). The out-of-pocket costs and
expenses incurred to obtain, prosecute and maintain Joint Patents shall be [*].
Calithera shall keep HPP informed of the status of all pending Joint Patents. In
the event that HPP believes that such patent strategy would have an
unreasonable, adverse, economic effect on High Point’s rights under this
Agreement (including inventorship or the value of any rights that HPP may obtain
under Section 12.5), HPP may elect to submit the dispute to an independent Third
Party patent counsel mutually agreed by Calithera and HPP, at HPP’s cost and
expense. If such patent counsel determines that such patent strategy would have
an unreasonable, adverse economic effect on High Point’s rights under this
Agreement (including inventorship or the value of any rights that HPP may obtain
under Section 12.5), then Calithera shall incorporate comments and adjust patent
strategy as advised by such independent Third Party patent counsel, and
Calithera shall [*]. Calithera shall not abandon any Joint Patent without at
least thirty (30) days’ prior notice to HPP. If Calithera determines to abandon
any Joint Patent in all or any portion of the Territory (the “Abandoned Joint
Patent”), Calithera shall notify HPP of such determination. If HPP wishes to
continue to prosecute and maintain the Abandoned Joint Patent, Calithera shall
have the option to continue to prosecute and maintain the Abandoned Joint Patent
at its expense or allow HPP to have the sole right, but not the obligation, to
continue to prosecute and maintain the Abandoned

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

Joint Patent [*]. Notwithstanding anything to the contrary, Calithera shall have
the option to regain control of prosecution and maintenance of an Abandoned
Joint Patent at any time, subject to [*] and [*] for such Abandoned Joint
Patent. If Calithera or HPP elects to continue to prosecute and maintain any
Abandoned Joint Patent, the other shall reasonably cooperate to transfer
prosecution and maintenance of such Abandoned Joint Patent.

(d) The Parties acknowledge that Calithera has the right, but not the
obligation, at its sole discretion, to submit applicable High Point Patent
Rights, Calithera Patent Rights and Joint Patents, and other relevant patent
information, to all applicable Governmental Authorities for listing in the
Orange Book or any similar listing or statutory or regulatory requirement in any
country or regulatory jurisdiction outside the United States. High Point or its
Affiliates, as applicable, shall provide, [*], all support reasonably necessary
for Calithera to exercise its rights under this Section 8.2(d). “Orange Book”
means the United States Food and Drug Administration publication titled,
“Approved Drug Products with Therapeutic Equivalence Evaluations”, as it may be
amended from time to time.

8.3. Third Party Infringement.

(a) Notice. Each Party shall promptly report in writing to the other Party
during the Term any known or suspected (i) infringement of any of the High Point
Patent Rights (including any Abandoned Patent or Unelected Patent) or Joint
Patents (including any Abandoned Joint Patent), or (ii) unauthorized use or
misappropriation of any of the High Point Know-How or Know-How in Joint
Inventions (an “Infringement Claim”) of which such Party becomes aware, and
shall provide the other Party with all available evidence supporting such known
or suspected infringement or unauthorized use.

(b) Initial Right to Enforce. Calithera shall have the sole right to enforce the
Calithera Patent Rights (including the Program Patent Rights) other than the
Joint Patents. Calithera shall have the first right, but not the obligation, to
initiate a suit or take other appropriate action that it believes is reasonably
required to protect (i.e., prevent or abate actual or threatened infringement or
misappropriation of) or otherwise enforce the High Point Intellectual Property
(including any Abandoned Patent or Unelected Patent), and the Parties’ rights in
Joint Inventions and Joint Patents (including any Abandoned Joint Patent). Any
suit by Calithera shall be either in the name of HPP or its Affiliate, the name
of Calithera or its Affiliate, or jointly by Calithera, Calithera’s
Affiliate(s), HPP and HPP’s Affiliate(s), as may be required by the Law of the
forum. For this purpose, High Point shall execute such legal papers and
cooperate in the prosecution of such suit as may be reasonably requested by
Calithera; provided that [*] in connection with such cooperation.

(c) Step-In Right. If Calithera does not initiate a suit or take other
appropriate action that it has the initial right to initiate or take pursuant to
Section 8.3(b) with respect to the High Point Patent Rights (including any
Abandoned Patent or Unelected Patent), Joint Patents (including any Abandoned
Joint Patent), High Point Know-How or Know-How in Joint Inventions, against a
Third Party as to which the Infringement Claim concerns a product for which a
Third Party is seeking or has received marketing approval from the FDA or a
corresponding foreign regulatory authority, HPP may provide Calithera with
notice of HPP’s intent to initiate a suit or take other appropriate action. If
HPP provides such notice and Calithera does not initiate a suit or take other
appropriate action to protect the High Point Patent Rights (including any
Abandoned Patent or Unelected Patent), Joint Patents (including any Abandoned
Joint Patent), High Point Know-How or Know-How in Joint Inventions within sixty
(60) days after receipt of such notice from HPP, then HPP shall have the right
to initiate a suit or take such other appropriate action that HPP believes is
reasonably required to protect the High Point Patent Rights (including any
Abandoned Patent or Unelected Patent), Joint Patents (including any Abandoned
Joint Patent), High Point Know-How or Know-How in Joint Inventions. Any suit by
HPP shall be either in the name of HPP or its Affiliate, the name of Calithera
or its Affiliate, or jointly by Calithera, Calithera’s Affiliate(s), HPP and
HPP’s Affiliate(s), as may be required by the Law of the forum. For this
purpose, Calithera shall execute such legal papers and cooperate in the
prosecution of such suit as may be reasonably requested by HPP; provided that
[*] in connection with such cooperation.

(d) Conduct of Certain Actions; Costs. The Party initiating suit shall have the
sole and exclusive right to select counsel for any suit initiated by it pursuant
to Section 8.3(b) or 8.3(c). The initiating Party shall assume and pay all of
its own out-of-pocket costs incurred in connection with any litigation or
proceedings initiated by it pursuant to Sections 8.3(b) and 8.3(c), including
the fees and expenses of the counsel selected by it. The other Party shall have
the right to participate and be represented in any such suit by its own counsel
at its own expense.

(e) Recoveries. In the event a Party assumes control over enforcing any
Infringement Claim, the other Party (which, in the case of High Point, shall be
HPP) shall be entitled to [*] any damages, settlements, accounts of profits, or
other financial compensation recovered from a Third Party based upon any such
Infringement Claim after deducting from the amount recovered the controlling
Party’s actual out‑of‑pocket expenses (including reasonable counsel fees and
expenses) incurred in pursuing such Infringement Claim, and the controlling
Party may retain the balance.

 

- 18 -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

8.4. Patent Invalidity Claim. Each of the Parties shall promptly notify the
other in the event of any legal or administrative action by any Third Party
against a High Point Patent Right (including an Abandoned Patent or Unelected
Patent) or Joint Patent (including an Abandoned Joint Patent) of which it
becomes aware, including any nullity, revocation, reexamination, inter partes
review, post-grant review, opposition, interference, derivation or compulsory
license proceeding. Calithera shall have the sole right to defend against any
such action involving a Calithera Patent Right or Program Patent Right.
Calithera shall have the first right, but not the obligation, to defend against
any such action involving a High Point Patent Right (including an Abandoned
Patent or Unelected Patent) or Joint Patent (including an Abandoned Joint
Patent) using counsel of its choice and the costs of any such defense shall be
[*]. High Point, upon request of Calithera, agrees to join in any such action
and to cooperate reasonably with Calithera; provided that [*] in connection with
such cooperation. If Calithera does not defend against any such action involving
such Patent Right, then HPP shall have the right, but not the obligation, to
defend such action and any such defense shall be [*]. Calithera, upon request of
HPP, agrees to join in any such action and to cooperate reasonably with HPP;
provided that [*] in connection with such cooperation.

8.5. Patent Term Extensions. Calithera shall have the exclusive right, and shall
use Commercially Reasonable Efforts, to seek patent term extensions or
supplemental patent protection, including supplementary protection certificates,
in any country in the Territory in relation to the Licensed Products [*]. High
Point and Calithera shall cooperate in connection with all such activities, and
Calithera, its agents and attorneys will give due consideration to all timely
suggestions and comments of HPP regarding any such activities; provided that all
final decisions shall be made by Calithera.

8.6. Patent Marking. Calithera shall comply with the patent marking statutes in
each country in which the Licensed Product is sold by Calithera, its Affiliates
or its Sublicensees.

8.7. Interpretation of Patent Judgments. If any claim relating to a patent under
the High Point Patent Rights (including an Abandoned Patent or Unelected Patent)
or Joint Patent (including an Abandoned Joint Patent) becomes the subject of a
judgment, decree or decision of a court, tribunal, or other authority of
competent jurisdiction in any country, which judgment, decree, or decision is or
becomes final (there being no further right of review) and adjudicates the
validity, enforceability, scope, or infringement of the same, the construction
of such claim in such judgment, decree or decision shall be followed thereafter
in such country in determining whether a product is a Licensed Product
hereunder, not only as to such claim but also as to all other claims in such
country to which such construction reasonably applies. If at any time there are
two or more conflicting final judgments, decrees, or decisions with respect to
the same claim, the decision of the higher tribunal shall thereafter control,
but if the tribunals be of equal rank, then the final judgment, decree, or
decision more favorable to such claim shall control unless and until the
majority of such tribunals of equal rank adopt or follow a less favorable final
judgment, decree, or decision, in which event the latter shall control.

8.8. Certification under Drug Price Competition and Patent Restoration Act.

(a) Notice. If a Party becomes aware of any certification filed pursuant to 21
U.S.C. § 355(b)(2)(A) or 355(j)(2)(A)(vii)(IV) (or any amendment or successor
statute thereto) claiming that any High Point Patent Rights (including an
Abandoned Patent or Unelected Patent) Covering a Licensed Product in the Field
or Joint Patents (including an Abandoned Joint Patent), are invalid or otherwise
unenforceable, or that infringement will not arise from the manufacture, use,
import or sale of a product by a Third Party (a “Paragraph IV Claim”), such
Party shall promptly notify the other Party in writing within five (5) Business
Days after its receipt thereof.

(b) Control of Response. Calithera shall have the right, but not the obligation,
to initiate patent infringement litigation for such Paragraph IV Claim, [*]. If
Calithera elects not to assume control over enforcing any Paragraph IV Claim,
Calithera shall notify HPP as soon as practicable but in any event not later
than ten (10) days before the first action required to enforce or preserve such
Paragraph IV Claim so that HPP may, but shall not be required to, assume sole
control over enforcing such Paragraph IV Claim using counsel of its own choice.
The Parties shall reasonably cooperate in the prosecution of any Paragraph IV
Claim, and share any compensation recovered as a result of such prosecution, as
set forth in Section 8.3(e) above; provided that [*] in connection with such
cooperation.

8.9. Consents as to Joint Inventions and Joint Patents.

(a) During the Term, (i) High Point hereby consents to Calithera having the sole
right and authority to control the licensing of the Joint Inventions and Joint
Patents and having the rights to prepare, file, prosecute and maintain the Joint
Inventions and Joint Patents in accordance with Section 8.2(c), and to enforce
the Joint Patents in accordance with Section 8.3, and (ii) Calithera hereby
consents to High Point having the right to enforce the Joint Patents in
accordance with Section 8.3(c).

 

- 19 -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

(b) Following the Term:

(i) Subject to High Point’s rights under Section 12.5, High Point hereby
consents to Calithera having the sole right to control the licensing of and
prepare, file, prosecute and maintain the Joint Inventions and Joint Patents in
accordance with Section 8.2(c).

(ii) If HPP elects to receive the license set forth in Section 12.5(e)(ii),
Calithera hereby consents to HPP thereafter having the sole right and authority
to control the licensing of the Joint Inventions and Joint Patents solely to
make, have made, use, sell, offer for sale and import the Program Molecules and
Licensed Products in the Territory and having the rights to prepare, file,
prosecute and maintain the Joint Inventions and Joint Patents in accordance with
Sections 8.2(c) and 12.5(e)(v), and to enforce the Joint Patents in accordance
with Section 12.5(e)(iii).

(iii) Subject to the rights set forth in subclause (ii) above, Calithera and HPP
shall mutually agree on the roles and responsibilities after the Term of each of
them with respect to the enforcement of Joint Inventions and Joint Patents prior
to either of them seeking to enforce any Joint Invention or Joint Patent.

ARTICLE IX.

CONFIDENTIAL INFORMATION

9.1. Treatment of Confidential Information. During the Term and for [*] years
thereafter, each Party shall maintain Confidential Information (as defined in
Section 9.2) of the other Party in confidence, and shall not disclose, divulge
or otherwise communicate such Confidential Information to others (except for
agents, directors, officers, employees, consultants, Affiliates and advisors
(collectively, “Agents”) under obligations of confidentiality no less stringent
than those contained herein) or use it for any purpose other than in connection
with the conduct of the Research Program, or the Development, Manufacture or
Commercialization of Program Molecules or Licensed Products pursuant to this
Agreement, and each Party shall exercise reasonable efforts to prevent and
restrain the unauthorized disclosure of such Confidential Information by any of
its Agents, which reasonable efforts shall be at least as diligent as those
generally used by such Party in protecting its own confidential and proprietary
information. Each Party will be responsible for a breach of this ARTICLE IX by
its Agents. For clarity, Calithera may disclose Confidential Information of High
Point (a) to Governmental Authorities (i) to the extent desirable to obtain or
maintain INDs or Regulatory Approvals for any Program Molecule or Licensed
Product within the Territory and (ii) in order to respond to inquiries, requests
or investigations by Governmental Authorities; (b) to outside consultants,
scientific advisory boards, managed care organizations, and non-clinical and
clinical investigators to the extent necessary to Develop or Commercialize any
Program Molecule or Licensed Product; and (c) to the extent desirable to obtain
Program Patent Rights to protect, or to Develop or Commercialize, any Program
Molecule or Licensed Product; provided that Calithera shall obtain the same
confidentiality obligations from such Third Parties as it obtains with respect
to its own similar types of confidential information.

9.2. Confidential Information. “Confidential Information” means all trade
secrets or other proprietary information, including any proprietary data and
materials (whether or not patentable or protectable as a trade secret),
regarding a Party’s or its licensor’s technology, products, business, financial
status or prospects or objectives regarding the Licensed Products, which is
disclosed by a Party to the other Party. All information disclosed prior to the
Effective Date by HPP to Calithera pursuant to the confidentiality agreement
between Calithera and HPP dated as of June 24, 2014, the confidentiality
agreement between Calithera and HPP dated as of August 12, 2014, as amended on
September 30, 2014, or the material transfer agreements between Calithera and
HPP, dated September 30, 2014 and November 5, 2014 (collectively, the
“Confidentiality Agreements”) shall be deemed “Confidential Information” of High
Point and all information disclosed prior to the Effective Date by Calithera to
High Point pursuant to the Confidentiality Agreements and all results from the
Research Program shall be deemed “Confidential Information” of Calithera.
Notwithstanding the foregoing, there shall be excluded from the foregoing
definition of Confidential Information any of the foregoing that:

(a) either before or after the date of the disclosure to the receiving Party is
lawfully disclosed to the receiving Party by Third Parties without any violation
of any obligation to the other Party; or

(b) either before or after the date of the disclosure to the receiving Party,
becomes published or generally known to the public through no fault or omission
on the part of the receiving Party or its Agents; or

(c) is independently developed by or for the receiving Party without reference
to or reliance upon the Confidential Information as demonstrated by
contemporaneous written records of the receiving Party; or

 

- 20 -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

(d) is required to be disclosed by the receiving Party to comply with applicable
Laws, to defend or prosecute litigation or to comply with governmental
regulations or the regulations or requirements of any stock exchange or
securities commission, provided that the receiving Party promptly provides prior
notice of such disclosure to the other Party and uses reasonable efforts to
avoid or minimize the degree of such disclosure.

9.3. Publication Rights.

(a) High Point shall not, and shall cause its controlled (as such word is
defined in Section 1.2) Affiliates and their respective employees, consultants,
contractors, licensees and agents not to, publish or publicly present any
results of any preclinical or clinical studies with respect to any Program
Molecule or Licensed Product without Calithera’s prior written consent, not to
be unreasonably withheld, conditioned or delayed. Calithera recognizes the
importance of each Party’s ability to make publications and in the spirit of
scientific advancement, in the event High Point wishes to publish or publicly
present such results, High Point shall submit the proposed publication to the
Development Forum sufficiently in advance of the proposed publication date to
allow Calithera to review and comment on the draft. Calithera shall advise the
Development Forum as to the timing of the proposed comments within thirty (30)
days of submission to the Development Forum.

(b) During the Research Term, Calithera shall provide to High Point the
opportunity to review any proposed abstracts, manuscripts or summaries of
presentations that cover any Program Molecule or Licensed Product as early as
reasonably practicable following Calithera’s publication of such proposed
abstract, manuscript or summary for publication or presentation.

9.4. 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.

ARTICLE X.

REPRESENTATIONS, WARRANTIES AND COVENANTS

10.1. High Point’s Representations. High Point hereby represents and warrants as
of the Effective Date as follows:

(a) High Point has the corporate power and authority to execute and deliver this
Agreement and to perform its obligations hereunder. The execution, delivery and
performance of this Agreement has been duly and validly authorized and approved
by proper corporate action on the part of High Point. High Point has taken all
other action required by Law, its certificate of incorporation or by-laws or any
agreement to which it is a party or by which it or its assets are bound, to
authorize such execution, delivery and (subject to obtaining all necessary
governmental approvals with respect to the continued Development of Licensed
Products) performance. Assuming due authorization, execution and delivery on the
part of Calithera, this Agreement constitutes a legal, valid and binding
obligation of High Point, enforceable against High Point in accordance with its
terms.

(b) The execution and delivery of this Agreement by High Point and the
performance by High Point, or its Affiliates or sublicensees, contemplated
hereunder will not violate (subject to obtaining all necessary governmental
approvals with respect to High Point’s obligations under the Research Program)
any United States Law or, to High Point’s knowledge, any Law of any Governmental
Authority outside the United States.

(c) Neither the execution and delivery of this Agreement nor the performance
hereof by High Point, or its Affiliates or sublicensees, requires High Point, or
its Affiliates or sublicensees, to obtain any permit, authorization or consent
from any Governmental Authority (subject to obtaining all necessary governmental
approvals with respect to the continued Development of Licensed Products) or
from any other Person, and such execution, delivery and performance by High
Point, or its Affiliates or sublicensees, will not result in the breach of or
give rise to any termination of, rescission, renegotiation or acceleration under
or trigger any other rights under any agreement or contract to which High Point,
or its Affiliates or sublicensees, as applicable, may be a party that relates to
the High Point Patent Rights or the High Point Know-How, except any that would
not, individually or in the aggregate, reasonably be expected to adversely
affect Calithera’s rights under this Agreement or the ability of High Point, or
its Affiliates or sublicensees, to perform its or their respective obligations
under this Agreement.

 

- 21 -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

(d) To High Point’s knowledge, no Third Party is infringing any of the High
Point Patent Rights. To the knowledge of High Point, the issued patents
encompassed within High Point Patent Rights are valid and enforceable patents
and no Third Party has challenged the validity or enforceability of such patents
(including by way of example through the institution or written threat of
institution of interference, nullity, revocation or similar invalidity
proceedings before the United States Patent and Trademark Office or any
equivalent foreign entity).

(e) High Point Controls the High Point Patent Rights identified on Schedule
1.37. None of High Point’s controlled (as such term is defined in Section 1.2)
Affiliates own or Control any intellectual property related to Hexokinase
Inhibitors. No other Person has any right, interest or claim in or to, and High
Point has not entered into any agreement granting any right, interest or claim
in or to, the High Point Patent Rights or High Point Know-How, including any
lien, encumbrance, charge, security interest, mortgage or other similar
restriction; provided, however, that High Point makes no representation or
warranty as to whether any other Person has independently developed rights to
scientific or technical information or related know-how or trade secrets. High
Point has entered into assignment agreements with all inventors of the High
Point Intellectual Property owned by High Point and, to High Point’s knowledge,
all assignments to High Point of ownership rights relating to the High Point
Patent Rights owned by High Point are valid and enforceable.

(f) Schedule 1.37 is a complete and correct list of all High Point Patent Rights
in the Territory owned by or licensed to High Point as of the Effective Date.

(g) 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 High
Point’s knowledge, threatened, against High Point in connection with any High
Point Patent Rights, High Point Know-How or against or relating to the
transactions contemplated by this Agreement.

(h) The information relating to High Point’s Hexokinase program that was
provided by High Point to Calithera prior to the Effective Date is, to High
Point’s knowledge, true and correct in all material respects.

10.2. Calithera’s Representations. Calithera hereby represents and warrants as
of the Effective Date as follows:

(a) Calithera has the corporate power and authority to execute and deliver this
Agreement and to perform its obligations hereunder. The execution, delivery and
performance of this Agreement has been duly and validly authorized and approved
by proper corporate action on the part of Calithera. Calithera has taken all
other action required by Law, its certificate of incorporation or by-laws or any
agreement to which it is a party or by which it or its assets are bound to
authorize such execution, delivery and (subject to obtaining all necessary
governmental approvals with respect to the Development, Manufacture and
Commercialization of Program Molecules and Licensed Products) performance.
Assuming due authorization, execution and delivery on the part of High Point,
this Agreement constitutes a legal, valid and binding obligation of Calithera,
enforceable against Calithera in accordance with its terms.

(b) The execution and delivery of this Agreement by Calithera and the
performance by Calithera contemplated hereunder will not violate (subject to
obtaining all necessary governmental approvals with respect to the continued
Development, Manufacture and Commercialization of Program Molecules and Licensed
Products) any United States Law or, to Calithera’s knowledge, any Law of any
Governmental Authority outside the United States.

(c) 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 the
knowledge of Calithera, threatened against Calithera in connection with or
relating to the transactions contemplated by this Agreement.

(d) Neither the execution and delivery of this Agreement nor the performance
hereof by Calithera requires Calithera to obtain any permit, authorization or
consent from any Governmental Authority (subject to obtaining all necessary
governmental approvals with respect to the continued Development, Manufacture
and Commercialization of Program Molecules and Licensed Products) or from any
other Person, and such execution, delivery and performance by Calithera will not
result in the breach of or give rise to any termination of, rescission,
renegotiation or acceleration under or trigger any other rights under any
agreement or contract to which Calithera may be a party that relates to the
Licensed Products, Calithera Patent Rights or Calithera Know-How, except any
that would not, individually or in the aggregate, reasonably be expected to
adversely affect High Point’s rights under this Agreement or the ability of
Calithera to perform its obligations under this Agreement.

 

- 22 -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

(e) The information relating to Calithera’s plans for pursuing a Hexokinase
program that was provided by Calithera to High Point prior to the Effective Date
is, to Calithera’s knowledge, true and correct in all material respects.

10.3. Mutual Covenant. Each Party shall conduct, and shall use reasonable
efforts to cause its contractors and consultants to conduct, all of its
activities contemplated under this Agreement in accordance with the Act, any
similar foreign Law, and all applicable Laws of the country in which such
activities are conducted.

10.4. No Warranty. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT,
NEITHER PARTY HERETO MAKES ANY REPRESENTATION AND EXTENDS NO WARRANTY OF ANY
KIND, EITHER EXPRESS OR IMPLIED. IN PARTICULAR, BUT WITHOUT LIMITATION, HIGH
POINT MAKES NO REPRESENTATION AND EXTENDS NO WARRANTY CONCERNING WHETHER ANY
PROGRAM MOLECULE IS FIT FOR ANY PARTICULAR PURPOSE OR SAFE FOR USE IN HUMANS.

ARTICLE XI.

INDEMNIFICATION

11.1. Indemnification in Favor of High Point. Calithera shall indemnify, defend
and hold harmless the High Point Parties (as hereinafter defined) from and
against any and all Losses incurred, suffered or sustained by any of the High
Point Parties or to which any of the High Point Parties becomes subject, arising
out of, relating to or resulting from any Third Party claim, action, suit,
proceeding, liability or obligation (collectively, “Third Party Claims”) arising
out of, relating to or resulting from:

(a) any misrepresentation or breach of any representation, warranty, covenant or
agreement made by Calithera in this Agreement; or

(b) the Development, Manufacture, use or Commercialization of a Program Molecule
or Licensed Product by Calithera, its Affiliates or Sublicensees, including all
Third Party Claims involving (A) death or bodily injury caused or allegedly
caused by the use of a Program Molecule or Licensed Product, and even if a
Program Molecule or Licensed Product is altered for use for a purpose not
intended or (B) any actual or alleged infringement of any trademark, Patent
Right or other intellectual property right, or misappropriation of any trade
secret, of any Third Party; or

(c) the gross negligence or willful misconduct of any of the Calithera Parties
(as hereinafter defined) in connection with Calithera’s performance of this
Agreement.

For purposes of this ARTICLE XI, “High Point Parties” means High Point, its
Affiliates and their respective licensors, agents, directors, officers,
employees and shareholders.

The indemnification obligations set forth in this Section 11.1 shall not apply
to the extent that any Loss is the result of a breach of this Agreement by High
Point or, with respect to any indemnitee, the gross negligence or willful
misconduct of such indemnitee.

11.2. Indemnification in Favor of Calithera. High Point shall indemnify, defend
and hold harmless the Calithera Parties from and against any and all Losses
incurred, suffered or sustained by any of the Calithera Parties or to which any
of the Calithera Parties becomes subject, arising out of, relating to or
resulting from any Third Party Claim arising out of, relating to or resulting
from:

(a) any misrepresentation or breach of any representation, warranty, covenant or
agreement made by High Point in this Agreement; or

(b) the gross negligence or willful misconduct of any of the High Point Parties
in connection with High Point’s performance of its obligations under this
Agreement.

For purposes of this ARTICLE XI, “Calithera Parties” means Calithera, its
Affiliates and their respective agents, directors, officers, employees and
shareholders.

The indemnification obligations set forth in this Section 11.2 shall not apply
to the extent that any Loss is the result of a breach of this Agreement by
Calithera or, with respect to any indemnitee, the gross negligence or willful
misconduct of such indemnitee.

 

- 23 -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

11.3. General Indemnification Procedures.

(a) A Person seeking indemnification pursuant to this ARTICLE XI (an
“Indemnified Party”) shall give prompt notice to the Party from whom such
indemnification is sought (the “Indemnifying Party”) of the commencement or
assertion of any Third Party Claim (which in no event includes any claim by any
Calithera Party or any High Point Party) in respect of which indemnity may be
sought hereunder, shall give the Indemnifying Party such information with
respect to any indemnified matter as the Indemnifying Party may reasonably
request, and shall not make any admission concerning any Third Party Claim,
unless such admission is required by applicable Law or legal process, including
in response to questions presented in depositions or interrogatories. Any
admission made by the Indemnified Party or the failure to give such notice shall
relieve the Indemnifying Party of any liability hereunder only to the extent
that the ability of the Indemnifying Party to defend such Third Party Claim is
prejudiced thereby (and no admission required by applicable Law or legal process
shall be deemed to result in prejudice). The Indemnifying Party shall assume and
conduct the defense of such Third Party Claim, with counsel selected by the
Indemnifying Party and reasonably acceptable to the Indemnified Party. Subject
to the initial and continuing satisfaction of the terms and conditions of this
ARTICLE XI, the Indemnifying Party shall have full control of such Third Party
Claim, including settlement negotiations and any legal proceedings. If the
Indemnifying Party does not assume the defense of such Third Party Claim in
accordance with this Section 11.3, the Indemnified Party may defend the Third
Party Claim. If both Parties are Indemnifying Parties with respect to the same
Third Party Claim, the Parties shall determine by mutual agreement, within
twenty (20) days following their receipt of notice of commencement or assertion
of such Third Party Claim (or such lesser period of time as may be required to
respond properly to such claim), which Party shall assume the lead role in the
defense thereof. Should the Indemnifying Parties be unable to mutually agree on
which of them shall assume the lead role in the defense of such Third Party
Claim, both Indemnifying Parties shall be entitled to participate in such
defense through counsel of their respective choosing.

(b) Any Indemnified Party or Indemnifying Party not managing the defense of a
Third Party Claim shall have the right to participate in (but not control), at
its own expense (subject to the immediately succeeding sentence), the defense.
The Indemnifying Party managing the defense shall not be liable for any
litigation cost or expense incurred, without its consent, by the Indemnified
Party (or an Indemnifying Party not managing the defense) where the action or
proceeding is under the control of such Indemnifying Party; provided, however,
that if the Indemnifying Party managing the defense fails to take reasonable
steps necessary to defend such Third Party Claim, the Indemnified Party may
assume its own defense, and the Indemnifying Party managing the defense will be
liable for all reasonable costs or expenses paid or incurred in connection
therewith.

(c) The Indemnifying Party shall not consent to a settlement of, or the entry of
any judgment against an Indemnified Party arising from any such Third Party
Claim to the extent such Third Party Claim involves equitable or other
non-monetary relief from the Indemnified Party. No Party shall, without the
prior written consent of the other Party or the Indemnified Party, enter into
any compromise or settlement that commits the other Party or the Indemnified
Party to take, or to forbear to take, any action.

(d) The Parties shall cooperate in the defense or prosecution of any Third Party
Claim and shall furnish such records, information and testimony, and attend such
conferences, discovery proceedings, hearings, trials and appeals, as may be
reasonably requested in connection therewith.

(e) Any indemnification hereunder shall be made net of any insurance proceeds
actually recovered by the Indemnified Party from unaffiliated Third Parties;
provided, however, that if, following the payment to the Indemnified Party of
any amount under this ARTICLE XI, such Indemnified Party recovers any such
insurance proceeds in respect of the claim for which such indemnification
payment was made, the Indemnified Party shall promptly pay an amount equal to
the amount of such proceeds (but not exceeding the amount of such net
indemnification payment) to the Indemnifying Party.

(f) The Parties agree and acknowledge that the provisions of this ARTICLE XI
represent the Indemnified Party’s exclusive recourse with respect to any Losses
for which indemnification is provided to the Indemnified Party under this
ARTICLE XI.

ARTICLE XII.

TERM AND TERMINATION

12.1. Term. The term of this Agreement (the “Term”) shall commence on the
Effective Date and, unless earlier terminated as provided in this ARTICLE XII,
shall continue in full force and effect, on a country-by-country and Licensed
Product-by-Licensed Product basis until there is no remaining royalty obligation
in such country with respect to such Licensed Product, at which time this
Agreement shall expire in its entirety with respect to such Licensed Product in
such country. The Term shall expire on the date the Agreement has expired with
respect to all Licensed Products in all countries in the Territory.

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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12.2. Termination for Convenience. Calithera shall have the right to terminate
this Agreement or the Research Program, at any time and for any reason, upon
ninety (90) days’ prior written notice to High Point. If Calithera terminates
this Agreement under this Section 12.2, then the provisions of Section 12.5
shall apply.

12.3. Termination for Breach. In the event of a material breach of this
Agreement by a Party, Calithera or HPP, as applicable, may give the Party in
default notice requiring it to cure such default. If such material breach is not
cured within [*] days after receipt of such notice, within [*] days in the case
of a payment breach, or within [*] days in the case of a breach of diligence
obligations as set forth in ARTICLE VI, Calithera or HPP, as applicable, shall
be entitled (without prejudice to any of its other rights conferred on it by
this Agreement or under applicable Law) to terminate this Agreement by giving
written notice to the defaulting Party, with such termination to take effect
immediately. The right of Calithera or HPP to terminate this Agreement as set
forth in this Section 12.3 shall not be affected in any way by its waiver of, or
failure to take action with respect to, any previous default. If HPP terminates
this Agreement under this Section 12.3, then the consequences set forth in
Section 12.5 shall apply. In the event that a Party is notified by Calithera or
HPP, as applicable, under this Section 12.3 that such Party (as applicable, the
“Defaulting Party”) has materially breached this Agreement, and such breach was
caused by a sublicensee of the Defaulting Party, and such breach is by its
nature curable, then the Defaulting Party shall have an additional [*] days
after the applicable cure period set forth in the second sentence of this
Section 12.3 to cure such breach.

12.4. Termination for Insolvency. This Agreement may be terminated by Calithera
or HPP upon written notice to the other if (a) the other Party (HPP or
Calithera, respectively) shall make an assignment for the benefit of its
creditors, file a petition in bankruptcy, petition or apply to any tribunal for
the appointment of a custodian, receiver or trustee for it or a substantial part
of its assets, or shall commence any proceeding under any bankruptcy,
reorganization, readjustment of debt, dissolution or liquidation law or statute
of any jurisdiction, whether now or hereafter in effect; or (b) if there shall
have been filed against HPP or Calithera, respectively, any such bona fide
petition or application, or any such proceeding shall have been commenced
against it, in which an order for relief is entered or that remains undismissed
or unstayed for a period of [*] days or more; or (c) if HPP or Calithera,
respectively, by any act or omission shall indicate its consent to, approval of
or acquiescence in any such petition, application or proceeding or order for
relief or the appointment of a custodian, receiver or trustee for it or any
substantial part of its assets, or shall suffer any such custodianship,
receivership or trusteeship to continue undischarged or unstayed for a period of
[*] days or more. Termination shall be effective upon the date specified in such
notice. If HPP terminates this Agreement under this Section 12.4, then the
provisions of Section 12.5 shall apply. If Calithera terminates this Agreement
under this Section 12.4, then the provisions of Section 12.6 shall apply.

12.5. Consequences of Certain Terminations by the Parties. If this Agreement is
terminated by Calithera under Section 12.2, or by HPP under Section 12.3 or
12.4, then the license granted to Calithera in Section 2.1 shall terminate, and
for a period of [*] days after such termination, HPP shall have the exclusive
right to elect, via written notice(s) to Calithera, to acquire, license or gain
access to all or a portion of the following as set forth in such notice(s). To
the extent reasonably accessible and without additional unreimbursed
out-of-pocket cost to Calithera, for a reasonable period of time, not to exceed
[*] but no less than [*] after HPP’s election under this Section 12.5, Calithera
shall provide such elected items and perform such elected activities, subject to
applicable Third Party agreements or legal obligations, including to clinical
sites, patients, institutional review boards, or Third Party vendors, as to whom
Calithera shall provide reasonable letters of introduction as requested by HPP;
provided that Calithera may keep a copy of all documents for its records or a
sample of any materials:

(a) Regulatory Matters. Ownership of all regulatory filings and Regulatory
Approvals relating to the Program Molecules and the Licensed Products, and
copies of related material correspondence with Regulatory Authorities, as
maintained as of the effective date of termination, and performance by Calithera
of the activities set forth on Schedule 12.5(a), subject to reimbursement of
reasonable internal costs of Calithera for such transfer, with the reasonable
internal rate for Calithera employees’ time not to exceed [*] per hour; provided
that the first [*] hours of Calithera employees’ time devoted to activities
under this Section 12.5(a) shall not be subject to reimbursement;

(b) Pre-clinical and Clinical Matters. All pre-clinical and clinical data,
including pharmacology and biology data, specifically relating to Program
Molecules and Licensed Products, but excluding any comparison data or business
analysis, and performance by Calithera of the activities set forth on Schedule
12.5(b) in each case to the extent in Calithera’s possession or control or, if
not in Calithera’s possession or control, to the extent Calithera’s standard
operating procedures provide for their preparation;

(c) High Point Documents and Materials. All documents and materials received
from High Point;

(d) Manufacturing Matters. Subject to (x) Calithera Patent Rights (which shall
be licensed pursuant to Section 12.5(e) below) and (y) Calithera’s proprietary
information and systems developed independently of this Agreement, subject to
applicable

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

agreements or legal obligations including to clinical sites, patients,
institutional review boards, or third-party vendors, provided that Calithera may
keep a copy of all documents for its records or a sample of any materials:

(i) assignment of each manufacturing agreement for Program Molecules or Licensed
Products to HPP (or, where such agreement is not specific to Program Molecules
or Licensed Products, the benefit thereof);

(ii) cooperation with HPP in reasonable respects to transfer manufacturing
documents and materials which are used (at the time of the termination) by
Calithera exclusively in the Manufacture of Program Molecules and Licensed
Products to the extent such manufacturing documents and materials are not
obtained by HPP pursuant to paragraph (i) above;

(iii) cooperation with HPP in reasonable respects to transfer manufacturing
technologies Controlled by Calithera which are used (at the time of the
termination) exclusively in the Manufacture of Program Molecules and Licensed
Products to the extent such manufacturing documents and materials are not
obtained by HPP pursuant to paragraphs (i) and (ii) above, provided that HPP
shall pay Calithera’s reasonable internal rates and expenses to provide such
requested assistance, with the reasonable internal rate for Calithera employees’
time not to exceed [*] per hour; provided that the first [*] hours of Calithera
employees’ time devoted to activities under this Section 12.5(d)(iii) shall not
be subject to reimbursement;

(iv) Calithera’s then existing inventory of Program Molecules and Licensed
Products to HPP, at [*], but only if the following conditions have been met: (A)
such Program Molecules and Licensed Products meet the applicable release
specifications; (B) Calithera does not reasonably believe the continued use of
such Program Molecules and Licensed Products cause safety concerns; and (C) HPP
shall not place into commerce products marked with Calithera’s House Marks as
defined in Section 12.5(f) below;

(v) in the event this Agreement is terminated after Initiation of a Phase III
Clinical Trial of a Licensed Product, use of Commercially Reasonable Efforts
using Calithera’s then existing manufacturing facilities and equipment to
Manufacture and supply HPP’s requirements of such Licensed Product for a period
of no longer than [*] after the effective date of termination, at [*], provided
that HPP shall not place into commerce products marked with Calithera’s House
Marks as defined in Section 12.5(f) below;

(e) License Grant. At HPP’s option, to be exercised no later than [*] days after
the effective date of termination:

(i) Effective upon the date of termination by Calithera under Section 12.2, or
by HPP under Section 12.3 or 12.4, Calithera shall and hereby does grant to HPP
a non-exclusive, fully paid-up, non-royalty-bearing, irrevocable, perpetual
license, with the right to grant sublicenses under multiple tiers, under the
Calithera Know-How solely to the extent required to make, have made, use, sell,
offer for sale and import the Program Molecules and the Licensed Products in the
Territory; provided that with respect to any Calithera Know-How that Calithera
acquired from another Person (by license or otherwise), Calithera shall only be
required to grant to HPP a license to such Calithera Know-How to the extent
permitted under its agreement with such Person, and, after the effective date of
termination, HPP shall pay Calithera or such Person any payment that becomes due
to such Person arising from the activities of HPP, its Affiliates or
sublicensees relating to the Program Molecules and Licensed Products; provided
further that HPP shall execute mutually acceptable documentation to effectuate
such agreement;

(ii) Effective upon the date of termination by Calithera under Section 12.2, or
by HPP under Section 12.3 or 12.4, Calithera shall and hereby does grant to HPP
an exclusive, royalty-bearing, irrevocable, perpetual license, with the right to
grant sublicenses under multiple tiers (A) under the Program Patent Rights
solely to the extent required to make, have made, use, sell, offer for sale and
import Program Molecules and Licensed Products in the Territory, and (B) under
the Calithera Patent Rights (that are not Program Patent Rights and that are
actually used in the discovery, Development, Commercialization or Manufacture of
any Program Molecule or Licensed Product) solely to the extent required to make,
have made, use, sell, offer for sale and import the Program Molecules and the
Licensed Products in the Territory. In consideration of such license, HPP shall
pay to Calithera following the effective date of termination a royalty equal to
(y) [*] of the royalties set forth in Section 7.6 of net sales of such Licensed
Products, if such termination [*] or (x) [*] of the royalties set forth in
Section 7.6 of net sales of such Licensed Products, if such termination [*] (in
each case with (1) such net sales being determined by applying the definitions
of Net Sales mutatis mutandis to any sales of such Licensed Products by HPP, its
Affiliates or sublicensees, and (2) the duration of such royalty payments being,
on a country-by-country basis, the period commencing on the first commercial
sale by HPP, its Affiliates or sublicensees in such country and ending on the
date on which the manufacture, use, sale, offer for sale or importation of such
Program Molecules or such Licensed Products in such country ceases to be Covered
by a valid claim of the Calithera Patent Rights or Program Patent Rights (with
valid claim to be determined by applying the definition of Valid Claim to
Calithera Patent Rights or Program Patent Rights) in such country; provided
that, with respect to any Calithera Patent Rights that Calithera acquired from
another Person (by license or otherwise), Calithera shall only be required to
grant to HPP a license to such Calithera Patent Rights to the extent permitted
under its agreement with such Person, and, after the effective date of
termination, HPP shall pay Calithera or such Person any payment that becomes due
to such

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

Person arising from the activities of HPP, its Affiliates or sublicensees
relating to such Program Molecules or such Licensed Products; provided further
that HPP shall execute mutually acceptable documentation to effectuate such
agreement;

(iii) With respect to enforcement of any Calithera Patent Rights or Program
Patent Rights (including Joint Patents) licensed to HPP pursuant to Section
12.5(e)(ii) above, HPP shall have the same rights as Calithera has with respect
to High Point Patent Rights pursuant to Section 8.3, but only with respect to
infringement that involves the making, using, selling, offering for sale and
importing of a product by a Third Party that contains a Hexokinase Inhibitor in
the Field in the Territory;

(iv) If Calithera determines to abandon in all or any portion of the Territory
any Calithera Patent Right (other than a Joint Patent) licensed to HPP pursuant
to Section 12.5(e)(ii) (the “Abandoned Calithera Patent”), Calithera shall
notify HPP of such determination, no later than thirty (30) days before any
deadline for further action to avoid abandonment.

(A) In the case of any pending application for an Abandoned Calithera Patent, if
HPP wishes to continue to prosecute such Abandoned Calithera Patent in such
Territory, Calithera may elect to continue to prosecute such Abandoned Calithera
Patent in such Territory or allow HPP to have the sole right, but not the
obligation, to continue to prosecute such Abandoned Calithera Patent [*]. HPP
may only elect to continue to prosecute such Abandoned Calithera Patent that
exclusively relates to Program Molecules or Licensed Products. To the extent
permitted by applicable Laws, a patent application that relates to, but does not
exclusively relate to, the Program Molecules or Licensed Products, will be split
such that the claims of the patent application only recite subject matter
exclusively related to Program Molecules or Licensed Products. Divisionals or
other patent applications that do not specifically relate to Program Molecules
or Licensed Products shall be excluded from the Calithera Patent Rights licensed
to HPP pursuant to Section 12.5(e)(ii).

(B) In the case of any issued Abandoned Calithera Patent, if HPP wishes to
continue to maintain such Abandoned Calithera Patent in such Territory,
Calithera may elect to continue to maintain such Abandoned Calithera Patent in
such Territory or allow HPP to have the sole right, but not the obligation, to
continue to maintain the Abandoned Calithera Patent [*].

(C) If either Party elects to continue to prosecute and maintain any Abandoned
Calithera Patent, the other Party shall reasonably cooperate to transfer such
prosecution and maintenance of such Abandoned Calithera Patent;

(v) Calithera shall have the right under Section 8.2(c) to regain control of
prosecution and maintenance of any Abandoned Joint Patent licensed to HPP at any
time, subject to [*] and [*] for such Abandoned Calithera Patent. If either
Party elects to maintain any Abandoned Calithera Patent, the other Party shall
reasonably cooperate to transfer such maintenance and prosecution thereof;

(vi) The roles of HPP and Calithera with respect to patent term extensions under
Section 8.5 shall be reversed;

(vii) If Calithera becomes aware of any certification filed pursuant to 21
U.S.C. § 355(b)(2)(A) or 355(j)(2)(A)(vii)(IV) (or any amendment or successor
statute thereto) claiming that any Calithera Patent Rights (including an
Abandoned Calithera Patent and Joint Patents, including an Abandoned Joint
Patent) licensed to HPP pursuant to Section 12.5(e)(ii) are invalid or otherwise
unenforceable, or that infringement will not arise from the manufacture, use,
import or sale of a product by a Third Party, Calithera shall promptly notify
HPP in writing within five (5) Business Days after its receipt thereof;

(f) Assignment of Trademark. Calithera agrees to and hereby assigns to HPP of
all of Calithera’s right, title and interest in any trademark used solely in
connection with the Licensed Products, provided that said assignment shall not
include any trademark relating to the name ‘Calithera’ or the business names or
trade names of any of Calithera’s Affiliates or Sublicensees (“House Marks”).

(g) Limitation on Remedy. In the event this Agreement is terminated by Calithera
under Section 12.2, or by High Point under Section 12.3 or 12.4, and HPP elects
to obtain any of the items under Section 12.5 then the fair market value of such
items obtained by HPP shall be deducted from any damages to which High Point may
otherwise be entitled hereunder in connection with such termination.

12.6. Payment of Balance of Quarterly Research Fees.

(a) If Calithera terminates this Agreement or the Research Program during the
Research Program Term pursuant to Section 12.2, then HPP shall retain all
Quarterly Research Fees paid by Calithera under Section 7.2 prior to the
effective date of such

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

termination, and [*] the effective date of such termination, which Quarterly
Research Fee shall be [*] the Research Program [*] (or [*] the Research Program)
[*] the date of termination and shall be [*] Quarterly Research Fee [*].

(b) If Calithera terminates this Agreement or the Research Program during the
Research Program Term pursuant to Section 12.3 or 12.4, then HPP shall retain
all Quarterly Research Fees paid by Calithera under Section 7.2 prior to the
effective date of such termination

(c) For purposes of clarity, a termination of the Research Program shall not
constitute a termination of the Agreement, unless explicitly stated in such
termination notice.

12.7. Unblock License. Upon termination or expiration of this Agreement (other
than a termination by High Point pursuant to Section 12.3 or 12.4), High Point
shall and hereby does grant to Calithera a perpetual, irrevocable, fully
paid-up, royalty-free, worldwide, non-exclusive license, with the right to grant
sublicenses under multiple tiers, under the High Point Sole Inventions conceived
under the Research Program, provided that if HPP exercises its option to obtain
the license set forth in Section 12.5(e)(ii), Calithera shall have no rights
under the license granted under this Section 12.7 to make, have made, use, sell,
offer for sale or import Program Molecules or Licensed Products in the Field in
the Territory.

12.8. Effect of Termination and Expiration; Accrued Rights and Obligations.
Termination of this Agreement for any reason shall not release either Party from
any liability that, at the time of such termination, has already accrued or that
is attributable to a period prior to such termination (including payment
obligations accrued prior to the effective date of termination pursuant to
Sections 7.4, 7.5 or 7.6) nor preclude either Party from pursuing any right or
remedy it may have hereunder or at Law or in equity with respect to any breach
of this Agreement. It is understood and agreed that monetary damages may not be
a sufficient remedy for any breach of this Agreement and that the non-breaching
Party may be entitled to seek injunctive relief as a remedy for any such breach.
HPP shall have no obligation to repay any Quarterly Research Fee paid pursuant
to Section 7.2 following any termination of this Agreement.

12.9. Survival. The rights and obligations set forth in this Agreement shall
extend beyond the Term or termination of this Agreement only to the extent
expressly provided for in this Agreement or to the extent required to give
effect to a termination of this Agreement or the consequences of a termination
of this Agreement as expressly provided for in this Agreement. Without limiting
the generality of the foregoing, it is agreed that the provisions of ARTICLE I,
Sections 2.3, 7.6(b) (with respect to the fully paid-up license granted
therein), 7.7, 7.8, 7.9, 7.10, 7.11, 7.12, 8.1, 8.2(a), 8.2(c) (and with respect
to Calithera Patent Rights, Joint Patents and Joint Inventions, only, and
subject to Sections 8.9(b) and 12.5(e), Sections 8.2(d), 8.3, 8.4, 8.7 and 8.8),
8.5 (subject to Section 12.5(e)(vi)), 8.9(b), 9.1, 9.2, 9.4, 11.1, 11.2, 11.3,
12.5, 12.6, 12.7, 12.8, 12.9, 13.1, 13.2, 13.3, 13.4, 13.5, 13.6, 13.7, 13.8,
13.9, 13.10, 13.11, 13.12, 13.13, 13.14, 13.15, 13.16 and 13.17 shall survive
expiration or termination of this Agreement for any reason.

ARTICLE XIII.

MISCELLANEOUS

13.1. Governing Law. This Agreement shall be governed by and interpreted in
accordance with the internal laws of the State of Delaware, without regard to
its conflicts of laws rules.

13.2. Jurisdiction. Each Party (a) irrevocably submits to the exclusive
jurisdiction in any state or federal court sitting in Wilmington, Delaware
(collectively, the “Courts”), for purposes of any action, suit or other
proceeding arising out of this Agreement, and (b) agrees not to raise any
objection at any time to the laying or maintaining of the venue of any such
action, suit or proceeding in any of the Courts, irrevocably waives any claim
that such action, suit or other proceeding has been brought in an inconvenient
forum and further irrevocably waives the right to object, with respect to such
action, suit or other proceeding, that such Court does not have any jurisdiction
over such Party. Either Party may serve any process required by such Courts by
way of notice under this Agreement pursuant to Section 13.4.

13.3. Waiver. Waiver by a Party of a breach hereunder by the other Party shall
not be construed as a waiver of any succeeding breach of the same or any other
provision. No delay or omission by a Party to exercise or avail itself of any
right, power or privilege that it has or may have hereunder shall operate as a
waiver of any right, power or privilege by such Party. No waiver shall be
effective unless made in writing with specific reference to the relevant
provision(s) of this Agreement and signed by a duly authorized representative of
the Party granting the waiver.

13.4. Notices. All notices, instructions and other communications hereunder or
in connection herewith shall be in writing, shall be sent to the address
specified in this Section 13.4 and shall be: (a) delivered personally; (b) sent
by registered or certified mail,

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

return receipt requested, postage prepaid; (c) sent via a reputable nationwide
overnight courier service; or (d) sent by facsimile transmission. Any such
notice, instruction or communication (except as provided expressly herein) shall
be deemed to have been delivered upon receipt if delivered by hand, three (3)
Business Days after it is sent by registered or certified mail, return receipt
requested, postage prepaid, one (1) Business Day after it is sent via a
reputable nationwide overnight courier service, or when transmitted with
electronic confirmation of receipt, if transmitted by facsimile (if such
transmission is on a Business Day; otherwise, on the next Business Day following
such transmission).

Notices to Calithera shall be addressed to:

Calithera Biosciences Inc.

343 Oyster Point Blvd #200

South San Francisco, CA 94080

Attention: Curtis Hecht

Vice President, Business and Corporate Development

Facsimile: (650) 588-5272

with a copy to:

Calithera Biosciences Inc.

343 Oyster Point Blvd #200

South San Francisco, CA 94080

Attention: Terri Davis

Associate Director, Intellectual Property and Legal Affairs

Facsimile: (650) 319-8093

and

Foley Hoag LLP

Seaport West

155 Seaport Boulevard

Boston, MA 02210-2600

Attention: Hemmie Chang

Facsimile: 617-832-7000

Notices to High Point shall be addressed to:

High Point Pharmaceuticals, LLC

4170 Mendenhall Oaks Parkway

High Point, NC 27265

Attention: President

Facsimile: 336-841-0310

with a copy to:

TransTech Pharma LLC

4170 Mendenhall Oaks Parkway

High Point, NC 27265

Attention: President

Facsimile: 336-841-0310

Either Party may change its address by giving notice to the other Party in the
manner provided above.

13.5. Entire Agreement. This Agreement (including Schedules) contains the
complete understanding of the Parties with respect to the research, Development,
Manufacture and Commercialization of Program Molecules and Licensed Products and
supersedes all prior understandings and writings relating to such subject
matter. In particular, and without limitation, it supersedes and replaces the

 

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[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

Confidentiality Agreements and any and all term sheets relating to the
transactions contemplated by this Agreement and exchanged between the Parties
prior to the Effective Date.

13.6. Headings. Headings in this Agreement are for convenience of reference only
and shall not be considered in construing this Agreement.

13.7. Severability. If any provision of this Agreement is held unenforceable by
a court or tribunal of competent jurisdiction because it is invalid or conflicts
with any Law of any relevant jurisdiction, the validity of the remaining
provisions shall not be affected. In such event, the Parties shall negotiate a
substitute provision that, to the extent possible, accomplishes the original
business purpose.

13.8. Registration and Filing of the Agreement. To the extent a Party determines
in good faith that it is required by applicable Law to publicly file, register
or notify this Agreement with a Governmental Authority, including public filings
pursuant to securities Laws, it shall provide the proposed redacted form of the
Agreement to the other Party a reasonable amount of time prior to filing for the
other Party to review such draft and propose changes to such proposed
redactions. The Party making such filing, registration or notification shall
incorporate any proposed changes timely requested by the other Party, absent a
substantial reason to the contrary, and shall use commercially reasonable
efforts to seek confidential treatment for any terms that the other Party timely
requests be kept confidential, to the extent such confidential treatment is
reasonably available consistent with applicable Law. Each Party shall be
responsible for its own legal and other external costs in connection with any
such filing, registration or notification.

13.9. Assignment. Neither this Agreement nor any right or obligation hereunder
may be assigned or otherwise transferred by Calithera, HPP or TransTech (the
“Assignor”) without the consent of the other Party; provided, however, that an
Assignor may, without such consent, assign this Agreement, in whole or in part:
(i) to any of its Affiliates, provided that the Assignor shall remain jointly
and severally liable with such Affiliate in respect of all obligations so
assigned or transferred and such Affiliate has acknowledged and confirmed in
writing that, effective as of such assignment or other transfer, such Affiliate
shall be bound by this Agreement as if it were a party to it as and to the
identical extent applicable to the Assignor; or (ii) to any successor in
interest by way of merger, acquisition or sale of all or substantially all of
its assets to which this Agreement relates, provided that such successor agrees
in writing to be bound by the terms of this Agreement as if it were the Assignor
and to assume all obligations of the Assignor under this Agreement. Any
purported assignment or transfer in violation of this Section 13.9 shall be
void. Notwithstanding the foregoing provisions of this Section 13.9, each Party
acknowledges and agrees that the other Party may satisfy any of its performance
obligations under this Agreement through permitted sublicensees in accordance
with Section 2.1(b) or 2.2(b).

13.10. Counterparts. This Agreement may be executed in counterparts, each of
which shall be deemed an original but all of which together shall constitute one
and the same instrument. Such counterparts may be exchanged by facsimile or PDF
(provided that each executed counterpart is transmitted in one complete
transmission or electronic mail message). Where there is an exchange of executed
counterparts by facsimile or PDF, each Party shall be bound by the Agreement
notwithstanding that original copies of the Agreement may not be exchanged
immediately. The Parties shall cooperate after execution of the Agreement and
exchange by facsimile or PDF to ensure that each Party obtains an original
executed copy of this Agreement with reasonable promptness.

13.11. Force Majeure. No Party shall be liable for failure of or delay in
performing obligations set forth in this Agreement, and no Party shall be deemed
in breach of its obligations, if such failure or delay is due to a natural
disaster, explosion, fire, flood, tornadoes, thunderstorms, earthquake, war,
terrorism, riots, embargo, losses or shortages of power, labor stoppage,
substance or material shortages, damage to or loss of product in transit, events
caused by reason of Laws of any Governmental Authority, events caused by acts or
omissions of a Third Party, or any other cause reasonably beyond the control of
such Party.

13.12. Press Releases and Other Disclosures. The Parties hereby each approve the
forms of separate press releases set forth in Schedule 13.12 hereto and will
cooperate in the release thereof as soon as practicable after the Effective
Date. The Parties also recognize that each Party may from time to time desire to
issue additional press releases and make other public statements or disclosures
regarding the subject matter of this Agreement. In such event, subject to
Section 9.4, the Party desiring to issue an additional press release or make a
public statement or disclosure shall provide the other Party with a copy of the
proposed press release, statement or disclosure for review and approval in
advance, which advance approval shall not be unreasonably withheld, conditioned
or delayed (except that neither Party shall have any obligation to disclose
Confidential Information except to the extent required or permitted pursuant to
ARTICLE IX). No other public statement or disclosure concerning the existence or
terms of this Agreement shall be made, either directly or indirectly, by either
Party, without first obtaining the written approval of the other Party. Once any
public statement or disclosure has been approved in accordance with this
Section, then either Party may appropriately communicate information contained
in such permitted statement or disclosure. Notwithstanding the foregoing
provisions of this Section 13.12 or of ARTICLE IX, a Party may (a) disclose the
existence and terms of the this Agreement where required, as

 

- 30 -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

reasonably determined by the disclosing Party, by applicable Law, by applicable
stock exchange regulation or by order or other ruling of a competent court, (b)
disclose the existence and terms of this Agreement under obligations of
confidentiality to agents, advisors, contractors, investors and sublicensees,
and to potential agents, advisors, contractors, investors and sublicensees, in
connection with such Party’s activities hereunder and in connection with such
Party’s financing activities and (c) publicly announce any of the matters set
forth in Schedule 13.12, provided that such announcements do not entail
disclosure of non-public technical or scientific information (which, for
purposes of clarity, excludes clinical trial results) and the announcing Party
provides the other Party with a copy of the proposed text of such announcement
sufficiently in advance of the scheduled release or publication thereof to
afford such other Party a reasonable opportunity to review and comment upon the
proposed text.

13.13. Third Party Beneficiaries. None of the provisions of this Agreement shall
be for the benefit of or enforceable by any Third Party other than an indemnitee
under ARTICLE XI. No such Third Party shall obtain any right under any provision
of this Agreement or shall by reason of any such provision make any claim in
respect of any debt, liability or obligation (or otherwise) against either
Party.

13.14. Relationship of the Parties. Each Party shall bear its own costs incurred
in the performance of its obligations hereunder without charge or expense to the
other, except as expressly provided in this Agreement. Neither Party shall have
any responsibility for the hiring, termination or compensation of the other
Party’s employees or for any employee compensation or benefits of the other
Party’s employees. No employee or representative of a Party shall have any
authority to bind or obligate the other Party for any sum or in any manner
whatsoever, or to create or impose any contractual or other liability on the
other Party without said other Party’s approval. For all purposes, and
notwithstanding any other provision of this Agreement to the contrary, the legal
relationship under this Agreement of each Party to the other Party shall be that
of independent contractor. Nothing in this Agreement shall be construed to
establish a relationship of partners or joint venturers between the Parties.

13.15. Performance by Affiliates. To the extent that this Agreement imposes
obligations on Affiliates of a Party, such Party agrees to cause its Affiliates
to perform such obligations.

13.16. Construction. Each Party acknowledges that it has been advised by counsel
during the course of negotiation of this Agreement, and, therefore, that this
Agreement shall be interpreted without regard to any presumption or rule
requiring construction against the Party causing this Agreement to be drafted.
Any reference in this Agreement to an Article, Section, subsection, paragraph,
clause or Schedule shall be deemed to be a reference to any Article, Section,
subsection, paragraph, clause or Schedule, of or to, as the case may be, this
Agreement. Except where the context otherwise requires, (a) wherever used, the
use of any gender will be applicable to all genders, (b) the word “or” is used
in the inclusive sense (and/or), (c) any definition of or reference to any
agreement, instrument or other document refers to such agreement, instrument
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 or therein), (d) any reference to any Laws refers to such Laws
as from time to time enacted, repealed or amended, (e) the words “herein”,
“hereof” and hereunder”, and words of similar import, refer to this Agreement in
its entirety and not to any particular provision hereof, (f) the words
“include”, “includes” and “including” shall be deemed to be followed by the
phrase “but not limited to”, “without limitation” or words of similar import,
and (g) all dollar ($) amounts specified herein are United States dollar
amounts.

13.17. No Consequential or Punitive Damages. NEITHER PARTY WILL BE LIABLE FOR
INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES,
INCLUDING LOST PROFITS, ARISING FROM OR RELATING TO THIS AGREEMENT, REGARDLESS
OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 13.17 IS INTENDED TO
LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY
UNDER THIS AGREEMENT WITH RESPECT TO THIRD PARTY CLAIMS, OR WITH RESPECT TO THE
INFRINGEMENT OR MISAPPROPRIATION OF THE OTHER PARTY’S INTELLECTUAL PROPERTY
RIGHTS OR CONFIDENTIAL INFORMATION.

[Remainder of page intentionally left blank.]

 

 

 

 

- 31 -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

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

 

CALITHERA BIOSCIENCES INC.

 

HIGH POINT PHARMACEUTICALS, LLC

 

By:

/s/ Susan Molineaux

 

By:

/s/ Stephen L. Holcombe

 

Name:

Susan Molineaux, Ph.D.

 

Name:

Stephen L. Holcombe

 

Title:

President & CEO

 

Title:

President & CFO

 

 

 

 

TRANSTECH PHARMA LLC

 

 

 

 

By:

/s/ Stephen L. Holcombe

 

 

 

 

Name:

Stephen L. Holcombe

 

 

 

 

Title:

President & CFO

 

 

 

 

 

- 32 -

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

Schedule 1.33

Hexokinase Inhibitor Assay

[*]

 

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

Schedule 1.37

High Point Patent Rights

 

File No.

Application No.

Filing Date

Assignee

Title

Status

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

Schedule 1.66

Research Plan

[*]

 

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

Schedule 7.2

(a)

 

Maximum Number of FTEs during Research Program Term

FTE Rate

Maximum Annual Payment by Calithera

Maximum Quarterly Payment by Calithera (Prorated for four (4) FTEs)

Four (4)

$275,000

$1,100,000

$275,000

 

(b)

 

Minimum Number of FTEs during Research Program Term

FTE Rate

Minimum Annual Payment by Calithera

Minimum Quarterly Payment by Calithera (Prorated for three (3) FTEs)

[*]

$275,000

$[*]

$[*]

 

(c)

 

 

Q1

Q2

Q3

Q4

Minimum Fee (Prorated for [*] FTEs)

$[*]

$[*]

$[*]

$[*]

Maximum Fee (Prorated for four (4) FTEs)

$275,000

$275,000

$275,000

$275,000

 

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

Schedule 7.10

HPP Wiring Instructions

 

Account Name:

High Point Pharmaceuticals LLC

Account Number:

[*]

 

Routing Number:

[*]

(for domestic transfers)

SWIFT Code:

[*]

(for international transfers)

 

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

Schedule 12.5(a)

Transition of Regulatory Matters

[*]

 

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

Schedule 12.5(b)

Transition of Pre-Clinical and Clinical Matters

[*]

 

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

Schedule 13.12

Press Releases

[g201505111544312631789.jpg]

Calithera Biosciences Gains Exclusive, Worldwide License to TransTech Pharma’s
Hexokinase II Inhibitor Program

South San Francisco, Calif., March 05, 2015 --(GLOBE NEWSWIRE)-- Calithera
Biosciences, Inc. (NASDAQ:CALA), a clinical-stage pharmaceutical company focused
on discovering and developing novel small molecule drugs directed against tumor
metabolism and tumor immunology targets for the treatment of cancer, announced
today an exclusive global license agreement with TransTech Pharma, a clinical
stage pharmaceutical company, granting Calithera exclusive world-wide rights to
research, develop and commercialize TransTech’s portfolio of hexokinase II
inhibitors. Hexokinase II is the first and rate-limiting enzyme in the pathway
that enables cancer cells to convert glucose to energy and building blocks that
feed cancer cell growth. Under the terms of the agreement, Calithera will obtain
exclusive, worldwide rights to TransTech’s hexokinase II inhibitors for
research, development and commercialization. TransTech will receive an upfront
payment and will be eligible to receive future development and commercialization
milestones as well as royalties on sales of approved products.

"TransTech’s hexokinase II inhibitor program will further expand Calithera’s
portfolio of pre-clinical programs and solidify our leadership in the area of
tumor metabolism drug research and development as we are now able to target two
essential nutrients that cancer cells rely on for growth and survival: glutamine
and glucose," said Susan M. Molineaux, CEO, Calithera Biosciences. "We believe
we can apply our expertise to rapidly advance TransTech’s potent small-molecule
hexokinase II inhibitors into the clinic to become our third potential
first-in-class therapy for cancer patients.”

About Tumor Metabolism and Hexokinase II Inhibitors

The field of tumor metabolism seeks to exploit the unique ways in which cancer
cells take up and utilize nutrients in order to grow and proliferate. Cancer
cells have altered cellular metabolic pathways to acquire and utilize these
nutrients and redirect them to provide the necessary building blocks for growth.
When these metabolic pathways are blocked, cancer cells are essentially starved
of critical nutrients and stop growing or die, whereas normal cells are largely
unaffected.

Most cancer cells have increased uptake of the sugar glucose relative to
surrounding normal cells. This phenomenon forms the basis for the widely used
tumor imaging procedure known as 18F-2-deoxyglucose (FDG)/PET. Tumors take up
more FDG, a radioactive glucose analog, than the surrounding normal tissue and
this differential can be visualized with PET imaging. Not only do tumors take up
more glucose, but they also utilize the nutrient in a unique way. Tumors convert
glucose into lactic acid in a process known as aerobic glycolysis or the
“Warburg effect”, a route rarely utilized in normal cells. This unique uptake
and processing of glucose by tumors relative to normal tissue creates an
opportunity to selectively target tumors by cutting off their ability to use
this fuel.

In many cancers, hexokinase II is over expressed and has been linked to more
aggressive and invasive tumors. Pre-clinical studies in mice have confirmed that
the reduction of hexokinase II activity through genetic deactivation (siRNA
knockdown studies) results in a significant reduction of tumor growth. The
hexokinase inhibitors in-licensed from TransTech may provide an opportunity to
inhibit the unique way cancer cells utilize glucose, and the overall Warburg
effect, which could result in new treatments for cancer.

About Calithera Biosciences

Calithera Biosciences, Inc. is a clinical-stage pharmaceutical company focused
on discovering and developing novel small molecule drugs directed against tumor
metabolism and tumor immunology targets for the treatment of cancer. Calithera's
lead product candidate, CB-839, an orally bioavailable inhibitor of glutaminase,
is currently being evaluated in three Phase 1 clinical trials in solid and
hematological cancers. Calithera is headquartered in South San Francisco. For
more information about Calithera, please visit www.calithera.com.

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

About TransTech Pharma

TransTech Pharma, LLC is a privately held, clinical-stage pharmaceutical company
focused on the discovery and development of human therapeutics to fill unmet
medical needs. The Company’s high-throughput drug discovery platform,
Translational Technology®, translates the functional modulation of human
proteins into safe and effective medicines. TransTech Pharma, LLC has a pipeline
of small-molecule clinical and pre-clinical drug candidates for the treatment of
a wide range of human diseases, including central nervous system disorders,
diabetes and metabolic disorders, inflammation and oncology. For further company
information, visit http://www.ttpharma.com

Forward-Looking Statements

This news release contains forward-looking statements by Calithera that involve
risks and uncertainties. These statements include those related to Calithera’s
ability to rapidly advance TransTech’s potent small-molecule hexokinase II
inhibitors into the clinic; that hexokinase II inhibitors may have therapeutic
potential in the treatment of cancer; and the potential of tumor metabolism
pathways to be transformational in the treatment of cancer. Actual results may
differ from Calithera's expectations and important factors that could cause
actual results to differ materially. Calithera's hexokinase II inhibitor program
or other potential product candidates that Calithera develops may not progress
through clinical development or receive required regulatory approvals within
expected timelines or at all. In addition, clinical trials may not confirm any
safety, potency or other product characteristics described or assumed in this
press release. Such product candidates may not be beneficial to patients or
successfully commercialized. The failure to meet expectations with respect to
any of the foregoing matters may have a negative effect on Calithera's stock
price. Additional information concerning these and other risk factors affecting
Calithera's business can be found in Calithera's Quarterly Report on Form 10-Q
for the period ended September 30, 2014 and other periodic filings with the
Securities and Exchange Commission at www.sec.gov. These forward-looking
statements are not guarantees of future performance and speak only as of the
date hereof, and, except as required by law, Calithera disclaims any obligation
to update these forward-looking statements to reflect future events or
circumstances.

SOURCE: Calithera Biosciences, Incorporated

CONTACT:

Jennifer McNealey

Calithera Biosciences, Inc.

ir@Calithera.com

650-870-1071

 

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

 

Schedule 13.12 (cont’d)

Press Releases

TransTech Pharma and Calithera Biosciences Enter Into Worldwide Licensing
Agreement for Hexokinase II Inhibitor Program

High Point, NC, March 05, 2015 - TransTech Pharma, LLC today announced a global
licensing agreement granting Calithera Biosciences, Inc. exclusive world-wide
rights to research, develop and commercialize TransTech’s portfolio of
hexokinase II inhibitors. TransTech will receive an upfront payment and will be
eligible to receive future development and commercialization milestones as well
as royalties on sales of approved products.

Hexokinase II is the first enzyme in the pathway that enables cancer cells to
convert glucose to energy and building blocks required for cancer cell growth.
The Warburg effect describes the particular reliance of cancer cells on
glycolysis for energy and tumor cell survival. FDG-PET imaging of cancer and
diagnosis in the clinic exploits the Warburg effect by detection of increased
uptake of a glucose analogue by cancer cells. Increased glycolysis has been
posited to be an essential part of carcinogenesis, conferring a significant
growth advantage as well as promoting typical tumor progression making it a new
promising modality for treatment of cancer.

“We are excited to be partnering our hexokinase II program with Calithera. We
selected Calithera because of their specific expertise and focus in tumor
metabolism research and development and look forward to our continued
partnership. This portfolio of hexokinase II inhibitors was discovered using our
Translational Technology® which has also been utilized in the discovery of our
other clinical and preclinical programs,” said Stephen L. Holcombe, President
and CFO, TransTech Pharma, LLC.

About TransTech Pharma, LLC

TransTech Pharma, LLC is a privately held, clinical-stage pharmaceutical company
focused on the discovery and development of human therapeutics to fill unmet
medical needs. The Company’s high-throughput drug discovery platform,
Translational Technology®, translates the functional modulation of human
proteins into safe and effective medicines. TransTech Pharma, LLC has a pipeline
of small-molecule clinical and pre-clinical drug candidates for the treatment of
a wide range of human diseases, including Alzheimer’s disease, diabetes and
other metabolic disorders, inflammation and oncology. For further company
information, visit http://www.ttpharma.com

About Calithera Biosciences, Inc.

Calithera Biosciences, Inc. (NASDAQ:CALA) is a clinical-stage pharmaceutical
company focused on discovering and developing novel small molecule drugs
directed against tumor metabolism and tumor immunology targets for the treatment
of cancer. Calithera's lead product candidate, CB-839, an orally bioavailable
inhibitor of glutaminase, is currently being evaluated in three Phase 1 clinical
trials in solid and hematological cancers. Calithera is headquartered in South
San Francisco. For more information about Calithera, please
visit www.calithera.com.

Contact:

TransTech Pharma, LLC

Nura Strong

336-841-0300 ext 164

nstrong@ttpharma.com

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.