Attached files
file | filename |
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EX-32.1 - EX-32.1 - Verastem, Inc. | vstm-20180630ex321f2134e.htm |
EX-99.1 - EX-99.1 - Verastem, Inc. | vstm-20180630ex991e6c5a2.htm |
EX-32.2 - EX-32.2 - Verastem, Inc. | vstm-20180630ex322293320.htm |
EX-31.2 - EX-31.2 - Verastem, Inc. | vstm-20180630ex3127fe469.htm |
EX-31.1 - EX-31.1 - Verastem, Inc. | vstm-20180630ex311054962.htm |
10-Q - 10-Q - Verastem, Inc. | vstm-20180630x10q.htm |
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
LICENSE AND COLLABORATION AGREEMENT
between
VERASTEM, INC.
and
YAKULT HONSHA CO., LTD
DATED
June 5, 2018
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
TABLE OF CONTENTS
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ARTICLE 1 DEFINITIONS |
1 | |
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ARTICLE 2 LICENSE |
13 | |
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2.1 |
Exclusive License Grant to Licensee |
13 |
2.2 |
Non-Exclusive License Grant to Licensee |
14 |
2.3 |
Right to Sublicense |
14 |
2.4 |
Right to Subcontract. |
15 |
2.5 |
Upstream Licenses |
16 |
2.6 |
Disclosure of the Verastem IP |
17 |
2.7 |
Verastem Retained Rights |
17 |
2.8 |
License Grant to Verastem |
17 |
2.9 |
No Implied Licenses; Negative Covenant |
17 |
2.10 |
Reimbursement for Third Party IP Sublicense |
17 |
2.11 |
Non-Compete |
18 |
2.12 |
[* * *] |
18 |
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ARTICLE 3 GOVERNANCE |
18 | |
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3.1 |
Alliance Managers |
18 |
3.2 |
Joint Steering Committee |
18 |
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ARTICLE 4 DEVELOPMENT |
21 | |
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4.1 |
Diligence and Responsibilities |
21 |
4.2 |
Development Plan |
21 |
4.3 |
Development Costs |
21 |
4.4 |
Development Records |
22 |
4.5 |
Clinical Trial Audit Rights |
22 |
4.6 |
Development Reports |
23 |
4.7 |
Data Exchange and Use |
23 |
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ARTICLE 5 REGULATORY |
24 | |
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5.1 |
Licensee’s Responsibilities |
24 |
5.2 |
Verastem’s Responsibilities |
25 |
5.3 |
Right of Reference and Use |
25 |
5.4 |
Adverse Events Reporting |
26 |
5.5 |
Safety and Regulatory Audits |
27 |
5.6 |
No Harmful Actions |
27 |
5.7 |
Notice of Regulatory Action |
28 |
i
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
ARTICLE 6 SUPPLY AND COMMERCIALIZATION |
28 | |
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6.1 |
Supply. |
28 |
6.2 |
Commercialization Diligence |
29 |
6.3 |
Commercialization Plan |
29 |
6.4 |
Commercialization Reports |
29 |
6.5 |
Commercial Forecast |
30 |
6.6 |
Coordination of Commercialization Activities |
30 |
6.7 |
Diversion |
30 |
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ARTICLE 7 PAYMENTS |
31 | |
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7.1 |
Upfront Payment |
31 |
7.2 |
Development Milestone Payments |
31 |
7.3 |
Sales Milestone Payments |
32 |
7.4 |
Royalty Payments to Verastem |
32 |
7.5 |
Late Payments |
34 |
7.6 |
Financial Records and Audits |
34 |
7.7 |
Taxes |
35 |
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ARTICLE 8 CONFIDENTIALITY; PUBLICATION |
36 | |
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8.1 |
Duty of Confidence |
36 |
8.2 |
Exemptions |
36 |
8.3 |
Authorized Disclosures |
37 |
8.4 |
Publications |
38 |
8.5 |
Publication and Listing of Clinical Trials |
39 |
8.6 |
Publicity; Use of Names |
39 |
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ARTICLE 9 REPRESENTATIONS, WARRANTIES, AND COVENANTS |
41 | |
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9.1 |
Representations, Warranties of Each Party |
41 |
9.2 |
Representations and Warranties of Verastem |
41 |
9.3 |
[* * *] |
42 |
9.4 |
Representations and Warranties of Licensee |
42 |
9.5 |
Covenant of Verastem |
42 |
9.6 |
Covenants of Licensee |
42 |
9.7 |
Compliance with Anti-Corruption Laws |
43 |
9.8 |
NO OTHER WARRANTIES |
44 |
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ARTICLE 10 INDEMNIFICATION |
44 | |
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10.1 |
By Licensee |
44 |
10.2 |
By Verastem |
45 |
10.3 |
Indemnification Procedure |
45 |
10.4 |
Mitigation of Loss |
46 |
10.5 |
Limitation of Liability |
46 |
ii
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
10.6 |
Insurance |
46 |
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ARTICLE 11 INTELLECTUAL PROPERTY |
46 | |
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11.1 |
Ownership |
46 |
11.2 |
Patent Prosecution |
47 |
11.3 |
Patent Enforcement |
47 |
11.4 |
Infringement of Third Party Rights |
48 |
11.5 |
Patents Licensed From Third Parties |
49 |
11.6 |
Product Trademarks |
49 |
11.7 |
Patent Marking |
50 |
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ARTICLE 12 TERMS AND TERMINATION |
51 | |
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12.1 |
Term |
51 |
12.2 |
Termination |
51 |
12.3 |
Effect of Termination. |
52 |
12.4 |
Bankruptcy Code §365(n) Election |
54 |
12.5 |
Accrued Rights |
54 |
12.6 |
Survival |
54 |
12.7 |
Termination Not Sole Remedy |
54 |
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ARTICLE 13 DISPUTE RESOLUTION |
55 | |
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13.1 |
General |
55 |
13.2 |
Negotiation; Escalation |
55 |
13.3 |
Arbitration |
55 |
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ARTICLE 14 MISCELLANEOUS |
57 | |
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14.1 |
Force Majeure |
57 |
14.2 |
Assignment |
57 |
14.3 |
Severability |
57 |
14.4 |
Notices |
58 |
14.5 |
Governing Law |
59 |
14.6 |
Entire Agreement; Amendments |
59 |
14.7 |
Headings |
59 |
14.8 |
Independent Contractors |
59 |
14.9 |
Waiver |
59 |
14.10 |
Waiver of Rule of Construction |
60 |
14.11 |
Cumulative Remedies |
60 |
14.12 |
Business Day Requirements |
60 |
14.13 |
Further Actions |
60 |
14.14 |
Construction |
60 |
14.15 |
Counterparts |
61 |
14.16 |
Language |
61 |
iii
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
LICENSE AND COLLABORATION AGREEMENT
This License and Collaboration Agreement (this “Agreement”) is made as of June 5, 2018 (the “Effective Date”), by and between Verastem, Inc., a Delaware corporation (“Verastem”), having a place of business at 117 Kendrick Street, #500, Needham, MA 02494, USA, and Yakult Honsha Co., Ltd., a Japanese corporation (“Licensee”), having a place of business at 1-19 Higashi Shimbashi 1-chome, Minato-ku, Tokyo, 105-8660, Japan. Verastem and Licensee are referred to in this Agreement individually as a “Party” and collectively as the “Parties.”
Whereas, Licensee has extensive experience and expertise in, the research, development and commercialization of pharmaceutical products in Japan;
Whereas, Verastem is a biopharmaceutical company that Controls (as defined below) certain intellectual property rights related to the pharmaceutical compound known as Duvelisib; and
Whereas, Licensee is interested in obtaining a license under such intellectual property rights to Develop and Commercialize Licensed Product in the Field in the Territory (each capitalized term as defined below), and Verastem is willing to grant such a license to Licensee, all subject to the terms and conditions set forth herein.
Agreement
Now, Therefore, in consideration of the foregoing premises and the covenants contained herein, the receipt and sufficiency of which are acknowledged, the Parties hereby agree as follows:
Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, shall have the respective meanings set forth below:
1.2 “Alliance Manager” has the meaning set forth in Section 3.1. |
1
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
1.3 “Anti-Corruption Laws” has the meaning set forth in Section 9.7(a)(i). |
1.5 “Arbitration Notice” has the meaning set forth in Section13.3(a). |
1.6 “Arbitrators” has the meaning set forth in Section 13.3(b). |
1.8 “[* * *] Clinical Trial” means the Clinical Trial with Protocol No. [* * *]. |
1.9 “Business Day” means a day other than a Saturday, Sunday or a day on which banking institutions in New York, New York or Tokyo, Japan are required by Applicable Laws to remain closed. |
1.10 “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31. |
1.11 “Calendar Year” means each twelve (12) month period commencing on January 1. |
1.13 “Clinical Trial” means any human clinical trial of a Licensed Product. |
2
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
this clause (b), an acquisition or a merger or consolidation of such Party or its controlling Affiliate in which the holders of shares of voting capital stock of such Party or its controlling Affiliate, as the case may be, immediately prior to such acquisition, merger or consolidation will beneficially own, directly or indirectly, at least fifty percent (50%) of the shares of voting capital stock of the acquiring Third Party or the surviving corporation in such acquisition, merger or consolidation, as the case may be, immediately after such acquisition, merger or consolidation. |
1.16 “Combination Product” means any pharmaceutical product which contains two or more active pharmaceutical ingredients, at least one of which is the Licensed Compound. For the avoidance of doubt, a Licensed Product containing the Licensed Compound as its sole active pharmaceutical ingredient will not constitute a Combination Product, even if it is co-administered with a pharmaceutical product containing one or more active pharmaceutical ingredients that are not the Licensed Compound. |
1.17 “Commercialization” or “Commercialize” means all activities directed to marketing, promoting, advertising, exhibiting, distributing (including storage for distribution or inventory), detailing, selling (and offering for sale or contracting to sell) or otherwise commercially exploiting (including pricing and reimbursement activities) a Licensed Product in the Field (including importing and exporting activities in connection therewith). |
1.18 “Commercialization Plan” has the meaning set forth in Section 6.3. |
1.19 “Commercially Reasonable Efforts” means, with respect to a Party’s obligations or activities under this Agreement, [* * *]. Commercially Reasonable Efforts of a Party shall require that such Party (on its own or acting through its Affiliates, Sublicensees or, Subcontractors), at a minimum, and without in any way limiting the foregoing: [* * *]. |
3
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
Regulatory Authorities). A synopsis of the [* * *] Study proposed as of the Effective Date is attached hereto as Exhibit G. |
1.22 “Control” or “Controlled” means the possession by a Party (whether by ownership, license or otherwise) of, (a) with respect to any tangible Know-How, the legal authority or right to physical possession of such tangible Know-How, with the right to provide such tangible Know-How to the other Party on the terms and conditions set forth herein, or (b) with respect to Patent Rights, intangible Know-How or other intellectual property rights, the legal authority or right to grant a license, sublicense, access or right to use (as applicable) under such Patent Rights, intangible Know-How or other intellectual property rights to the other Party on the terms and conditions set forth herein, in each case of (a) and (b), without breaching the terms of any agreement with a Third Party in existence as of the time such Party or its Affiliates would first be required hereunder to grant the other Party such access, right to use or (sub)license. |
1.23 “CRO” means a contract research organization. |
1.25 "Development Data" shall mean written reports of pre-clinical studies and Clinical Trials primarily containing non-clinical, clinical or CMC data relating to the Licensed Compound or the Licensed Products in the Field, and supporting documentation (e.g., protocols, format of case report forms, analysis plans) for such reports. Notwithstanding any provision of this Agreement to the contrary, Development Data that Verastem is required to deliver to Licensee under this Agreement shall be limited to Development Data that is Controlled by Verastem and is |
4
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
necessary or useful to support the Development, Regulatory Approval or Commercialization of a Licensed Product in the Territory. Licensee’s use of such Development Data in connection with applications for Regulatory Approval shall be subject to Licensee’s payment obligations under Section 5.3(b). |
1.26 “Development Plan” has the meaning set forth in Section 4.2. |
1.27 “Disclosing Party” has the meaning set forth in Section 8.1(a). |
1.28 “DLBCL” means diffuse large B-cell lymphoma. |
1.29 “Dollar” or “$” means the U.S. dollar, and “$” shall be interpreted accordingly. |
1.30 “Early Access Program” means any program that provides patients with a Licensed Product prior to Regulatory Approval in the Territory and in which the use of the Licensed Product is not primarily intended to obtain information about the safety or effectiveness of a drug. “Early Access Programs” shall include treatment INDs / protocols, named patient programs and compassionate use programs. |
1.31 “Entity” means a partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization. |
1.32 “Executive Officers” has the meaning set forth in Section 3.2(e). |
1.33 “Existing Confidentiality Agreement” has the meaning set forth in Section 1.20. |
1.34 “Exploit” or “Exploiting” means to (a) Develop, (b) obtain, hold and maintain Regulatory Approvals, and any pricing or reimbursement approvals, as applicable, (c) Manufacture, or (d) Commercialize Licensed Products. |
1.35 “Field” means the treatment, prevention, palliation or diagnosis of any oncology Indication in humans or animals. |
1.37 “FL” means follicular lymphoma. |
1.38 “[* * *] Study” means the Registrational Trial planned by Verastem for the Licensed Product in FL to [* * *]. |
5
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
1.39 “FTE” means the equivalent of the work of a full-time individual for a twelve (12) month period. |
1.41 “Fully Burdened Manufacturing Cost” means, with respect to any Licensed Product supplied by or on behalf of Verastem to Licensee hereunder: |
(a) to the extent that such Licensed Product (or any precursor or intermediate thereof) is Manufactured by a Third Party manufacturer, [* * *]; plus |
(b) to the extent that such Licensed Product (or any precursor or intermediate thereof) is Manufactured by Verastem or its Affiliates, [* * *]. Such fully burdened costs shall be calculated in accordance with United States GAAP. |
1.44 “Generic Product” means, with respect to a Licensed Product in the Territory, a pharmaceutical product that (a) contains the same active pharmaceutical ingredients (and no other active pharmaceutical ingredients) as such Licensed Product, (b) is approved by the PMDA based on reference to data contained in an earlier Regulatory Approval for such Licensed Product, and (c) is sold by a Third Party that is not a Sublicensee and did not purchase such product or its active pharmaceutical ingredients from Licensee or its Affiliates or Sublicensees. |
6
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
1.45 “Global Clinical Trial” means a Clinical Trial conducted by Verastem (or any of its Affiliates, Third Party Licensees or Subcontractors) in cooperation with Licensee both inside and outside the Territory under the Global Strategy, which Global Clinical Trial shall be governed by the following: |
(a) if Verastem plans to conduct a multi-national Clinical Trial, the JSC shall discuss and agree upon whether such multi-national Clinical Trial should include the Territory, [* * *]; and |
(b) in the event that the JSC agrees to include the Territory in such multi-national Clinical Trial, such Clinical Trial shall be regarded as a Global Clinical Trial (and if the JSC determines that such multi-national Clinical Trial will not include the Territory, such multi-national Clinical Trial shall be regarded as a Verastem New Clinical Trial). |
1.46 “Global Strategy” means Verastem’s worldwide Development, regulatory and Commercialization strategy with respect to the Licensed Compound and Licensed Products, including the designation of Indications for which to seek Regulatory Approval and Verastem’s global publication strategy. |
1.47 “GLP” means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then-current good laboratory practice standards promulgated or endorsed by the U.S. Food and Drug Administration, as defined in 21 C.F.R. Part 58, and the equivalent Applicable Laws in the Territory, each as may be amended and applicable from time to time. |
1.48 “Governmental Authority” means any federal, state, national, state, provincial or local government, or political subdivision thereof, or any multinational organization or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, or any court or tribunal (or any department, bureau or division thereof, or any governmental arbitrator or arbitral body). |
1.49 “ICH Guidelines” mean the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline. |
1.50 “Indemnified Party” has the meaning set forth in Section 10.3. |
1.51 “Indemnifying Party” has the meaning set forth in Section 10.3. |
1.52 “Indication” means a disease, condition, disorder or syndrome. |
1.53 “Infinity” has the meaning set forth in Section 2.5(a)(i). |
1.54 “Infinity Agreement” has the meaning set forth in Section 2.5(a)(i). |
7
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
1.55 “Infringed Patent Right” has the meaning set forth in Section 7.4(c). |
1.56 “Initial Tech Transfer” has the meaning set forth in Section 2.6. |
1.57 “INK” has the meaning set forth in Section 2.5(a)(i). |
1.58 “INK Agreement” has the meaning set forth in Section 2.5(a)(i). |
1.59 “Invention” means any information, discovery, improvement, modification, process, method, assay, design, protocol (including any Clinical Trial protocol), formula, data, invention, algorithm, forecast, profile, strategy, plan, result, know-how or trade secret (in each case, whether or not patentable), that is discovered, generated, conceived or reduced to practice by or on behalf a Party (including by its Affiliates, licensees, Sublicensees, Subcontractors or their respective employees, agents), in the course of the performance of this Agreement, including all rights, title and interest in and to the intellectual property rights therein and thereto. |
1.60 “JPT” has the meaning set forth in Section 3.2(f). |
1.61 “JSC” has the meaning set forth in Section 3.2(a). |
1.63 “License” means the licenses granted by Verastem to Licensee pursuant to Section 2.1 and Section 2.2. |
1.64 “Licensed Compound” means the compound known by the names INK1197, IPI-145 or duvelisib (INN; International Nonproprietary Names), as described on Exhibit B, or any of its various chemical forms, including acids, bases, salts, metabolites, esters, isomers, enantiomers, pro-drug forms, hydrates, solvates, polymorphs and degradants thereof, in each case that has substantially the same pharmacological effect, in crystal, powder or other form. |
1.65 “Licensed Product” means any pharmaceutical product that contains or comprises the Licensed Compound. [* * *]. Each Licensed Product shall be distinguished by dosage form, and for the avoidance of doubt, Licensed Product containing the Licensed Compound as its sole active pharmaceutical ingredient and each Combination Product shall constitute separate and distinct Licensed Products under this Agreement. |
8
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
1.66 “Licensed Trademarks” means the trademarks set forth on Exhibit F, to the extent Controlled by Verastem in the Territory. |
1.67 “Licensee Indemnitees” has the meaning set forth in Section 10.2. |
1.68 “Licensee IP” means Licensee Know-How and Licensee Patents. For clarity, Inventions owned by Licensee pursuant to Section 11.1(b) shall be included within the Licensee IP. |
1.69 “Licensee Know-How” means all Know-How Controlled by Licensee or its Affiliates as of the Effective Date or at any time during the Term (including any and all data, Clinical Trial data, results, Development Data and Regulatory Documents generated by or on behalf of Licensee, its Affiliates, Sublicensees or Subcontractors) relating to the Licensed Compound or Licensed Product that is necessary or reasonably useful for Exploiting the Licensed Products in the Field. |
1.70 “Licensee Patents” means all Patent Rights Controlled by Licensee or its Affiliates as of the Effective Date or at any time during the Term that cover the Licensed Compound or Licensed Product (including composition of matter and methods of using, making or detecting the Licensed Compound or the Licensed Products). |
[* * *]
Such amounts shall be determined from the books and records of Licensee, its Affiliates and its Sublicensees, in each case maintained in accordance with Japanese GAAP or International Financial Reporting Standards, consistently applied.
9
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
confirmation patent or registration patent or patent of addition based on any such patent, patent term extensions, and supplemental protection certificates or requests for continued examinations, foreign counterparts, and the like of any of the foregoing. |
1.74 “Patent Prosecution” means activities directed to (a) preparing, filing and prosecuting applications (of all types) for any Patent Right, (b) managing any interference, opposition, re-issue, reexamination, supplemental examination, invalidation proceedings (including inter partes or post-grant review proceedings), revocation, nullification, or cancellation proceeding relating to the foregoing Patent Rights, (c) maintaining issued Patent Right(s), (d) listing in regulatory publications (as applicable), (e) patent term extension for issued Patent Right(s) and maintenance thereof, and (f) managing, including settling, any interference, opposition, reexamination, invalidation, revocation, nullification or cancellation proceeding relating to issued Patent Right(s). |
1.75 “Person” means any individual, unincorporated organization or association, Entity, Governmental Authority or governmental agency. |
1.77 “PMDA” means the Japanese Pharmaceuticals and Medical Devices Agency, and local counterparts thereto, and any successor agency(ies) or authority thereto having substantially the same function. |
1.79 “[* * *] Clinical Trial” means the Clinical Trial with Protocol No. [* * *]. |
1.80 “Product Infringement” has the meaning set forth in Section 11.3(a). |
1.81 “Product Marks” has the meaning set forth in Section 11.6(b). |
1.82 “Product Recall” means any recall or market withdrawal of a Licensed Product in the Territory. |
1.83 “PTCL” means peripheral T-cell lymphoma. |
1.84 “Public Official” has the meaning set forth in Section 9.7(d). |
1.85 “Publication” has the meaning set forth in Section 8.4. |
1.86 “Quality Agreement” has the meaning set forth in Section 6.1(b). |
10
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
1.87 “Receiving Party” has the meaning set forth in Section 8.1(a). |
1.88 “Registrational Trial” means a controlled or uncontrolled human Clinical Trial of a Licensed Product that is intended (as of the time the first patient is enrolled in the Clinical Trial) to obtain sufficient data and results to support the filing of an application for Regulatory Approval without the requirement for any further Clinical Trial prior to submission of such application to the applicable Regulatory Authority. |
1.89 “Regulatory Approval” means, with respect to a Licensed Product in a country, all regulatory approvals granted by the applicable Regulatory Authority that are necessary for the Commercialization of such Licensed Product in such country, excluding any pricing and reimbursement approvals in connection therewith. |
1.92 “Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a pharmaceutical product, including any such right that may become available following the Effective Date, including orphan drug exclusivity, new chemical entity exclusivity, data exclusivity, pediatric exclusivity, rights conferred in the United States under the Hatch-Waxman Act or the USFDA Modernization Act of 1997 (but excluding any patent term extension mechanism), or rights similar thereto outside the United States, but in all cases excluding Patent Rights and patent term extensions based on such rights. |
11
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
1.94 “Rules” has the meaning set forth in Section13.3(a). |
1.95 “Sales Milestone Event” has the meaning set forth in Section 7.3. |
1.96 “Sales Milestone Payment” has the meaning set forth in Section 7.3. |
1.97 “SEC” has the meaning set forth in Section 8.6(c). |
1.98 “Subcontractor” has the meaning set forth in Section 2.4(a). |
1.99 “Sublicensee” has the meaning set forth in Section 2.3(b). |
1.100 “Supply Agreement” has the meaning set forth in Section 6.1(a). |
1.103 “Territory” means Japan. |
1.105 "Third Party Licensee" means any Third Party holding a license (whether exclusive or non-exclusive) under the Verastem IP in the Field outside of the Territory. |
1.106 “TP-IP Sublicense Payments” has the meaning set forth in Section 2.10. |
1.107 “United States” means the United States of America. |
1.108 “Upstream License Agreement” has the meaning set forth in Section 2.5(a)(i). |
1.109 “Upstream Licensors” has the meaning set forth in Section 2.5(a)(i). |
1.111 “USFDA” means the United States Food and Drug Administration or any successor Entity thereto. |
1.112 “Valid Claim” means a claim of any (a) issued, unexpired patent that has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal, and that has not been disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise or (b) a pending patent |
12
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
application that has not been finally abandoned, finally rejected or expired (after exhaustion of all appeals); provided, however, that if a claim of a pending patent application shall not have issued within [* * *] years after the earliest filing date from which such claim takes priority, such claim shall not constitute a Valid Claim for the purposes of this Agreement unless and until a patent issues with such claim. |
1.113 “VAT” means the value added taxes. |
1.114 “Verastem New Clinical Trial” means any Clinical Trial in which the first patient is enrolled after the Effective Date and that is conducted by Verastem or any of its Affiliates, Third Party Licensees or Subcontractors solely outside the Territory. Notwithstanding the foregoing, and for the avoidance of doubt, the [* * *] Clinical Trial and the [* * *] Clinical Trial shall be deemed Verastem New Clinical Trials. |
1.115 “Verastem Indemnitees” has the meaning set forth in Section 10.1. |
1.116 “Verastem IP” means Verastem Know-How, Verastem Patents, and the Licensed Trademarks. For clarity, Inventions owned by Verastem in accordance with Section 11.1(a) shall be included in the Verastem IP. |
1.117 “Verastem Know-How” means all Know-How Controlled by Verastem as of the Effective Date or at any time during the Term (subject to the provisions of Section 2.11 that is necessary or reasonably useful for the Development, Manufacture or Commercialization of Licensed Products in the Field in the Territory; provided, however, that Verastem Know-How shall exclude all Know-How that comes into Verastem’s Control as a result of a Change of Control of Verastem. |
1.119 “Working Group” has the meaning set forth in Section 3.2(g). |
13
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
(i) Licensee shall have the right to grant sublicenses of the License to Third Parties to fulfill any of its obligations under this Agreement (any such Third Party, a “Sublicensee”), and Licensee shall notify Verastem in writing of such sublicense. Notwithstanding the foregoing, Licensee shall obtain Verastem’s prior written consent if Licensee wishes to sublicense all or substantially all of Licensee’s rights or obligations to a Third Party under this Agreement in the Territory. |
14
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
(iii) Licensee shall Control, or shall cause Sublicensees to assign to Licensee, all intellectual property rights with respect to the Licensed Compound or Licensed Products that are made, discovered, developed or otherwise created by such Sublicensees in the course of performing such sublicense agreement. |
15
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
(b) Verastem shall have the right to engage its Subcontractors to perform its activities for which Verastem is assuming obligations under this Agreement, provided, that (i) Verastem shall remain directly responsible for any activities that have been subcontracted to its Subcontractor and shall be responsible for the performance of its Subcontractors, and (ii) any breach by a Subcontractor of the terms and conditions of this Agreement shall be deemed a breach by Verastem of such terms and conditions. Verastem shall Control, or shall cause its Subcontractors to assign to Verastem, all intellectual property rights solely relating to the Licensed Compound or Licensed Product (including, for the avoidance of doubt, Development Data resulting from such subcontracted activities) that are made, discovered, developed or otherwise created by such Subcontractors in the course of performing such subcontracted activities. |
(a) Licensee acknowledges and agrees that: |
(ii) Licensee shall, and shall cause its Affiliates and Sublicensees to, comply in all material respects with the Upstream License Agreements and take any action reasonably requested by Verastem to prevent any potential material breach by Licensee, its Affiliates or Sublicensees of any applicable term of any Upstream License Agreements; |
(iii) it has received a redacted copy of the INK Agreement and a copy of the Infinity Agreement existing as of the Effective Date; and |
(iv) notwithstanding any provision of this Agreement to the contrary, (A) Verastem may provide a copy of this Agreement, and any amendment to this Agreement, to any Upstream Licensor, and (B) Verastem may provide to any Upstream Licensor any information required to be provided to such Upstream Licensor in accordance with the applicable Upstream License Agreement. Verastem acknowledges and agrees that Licensee may provide to any Affiliate or Sublicensee a copy of the Upstream License Agreement and this Agreement; provided that such Affiliate or Sublicensee is subject to confidentiality and non-use obligations no less stringent than those set forth in Article 8. |
(b) [* * *] |
16
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
17
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
2.11 Non-Compete. During the Term, Licensee shall not, and shall ensure that its Affiliates and Sublicensees do not, [* * *], without the prior written consent of Verastem. |
2.12 [* * *]. |
18
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
Territory; and (vii) perform such other functions as expressly set forth in this Agreement or allocated to the JSC by the Parties’ written agreement. |
(c) Limitation of Authority. The JSC shall only have the powers expressly assigned to it in this Article 3 and elsewhere in this Agreement and shall not have the authority to: (i) modify or amend the terms and conditions of this Agreement (except for amendments to the Development Plan pursuant to Section 4.2); (ii) waive either Party’s compliance with the terms and conditions of this Agreement; or (iii) determine any issue in a manner that would conflict with the express terms and conditions of this Agreement. |
19
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
(i) Non-Member Attendance. Each Party may from time to time invite a reasonable number of participants, in addition to its representatives, to attend a meeting of the JSC (in a non-voting capacity), JPT or any Working Group in the event that the planned agenda for such JSC, JPT or Working Group meeting would require such participants’ expertise; provided that if either Party intends to have any Third Party (including any consultant) attend such a meeting, such Party shall provide [* * *] days prior written notice to the other Party and shall ensure that such Third Party is bound by a written confidentiality and non-use agreement consistent with the terms of this Agreement. |
20
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
(b) Without limiting the foregoing, with respect to the Global Clinical Trials, Licensee shall have a right to elect, at its sole discretion, to perform certain Development activities such as monitoring and site management in the Territory by using its internal clinical research associates. If Licensee elects (i) to perform such Development activities of a Global Clinical Trial in the Territory, Licensee shall, in collaboration with any global CRO engaged by Verastem to conduct such Global Clinical Trial (including any local Affiliate of a global CRO or global service provider), use Commercially Reasonable Efforts to perform the Development activities in the Territory that are assigned to Licensee for purposes of contributing to such Global Clinical Trial, or (ii) not to perform such Development activities of a Global Clinical Trial in the Territory by using its internal clinical research associates, such Development activities shall be performed by a global CRO engaged by Verastem instead. |
21
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
(b) Notwithstanding Section 4.3(a) above, with respect to a Global Clinical Trial, Licensee shall bear (i) all costs incurred by Licensee, its Affiliates, its Sublicensees or its Subcontractors to the extent Licensee, its Affiliates, its Sublicensees, or its Subcontractors perform Development activities in connection with such Global Clinical Trial in the Territory, (ii) all costs incurred by Verastem, its Affiliates, its Third Party Licensees or its Subcontractors to the extent Verastem, its Affiliates, its Third Party Licensees or its Subcontractors perform Development activities in connection with such Global Clinical Trial in the Territory, to the extent Licensee does not perform Development activities of such Global Clinical Trial in the Territory; and (iii) a pro rata portion of the common expenses (e.g., study management cost and data management cost) [* * *]. Verastem may invoice Licensee on a [* * *] basis for the foregoing costs incurred by Verastem with respect to the Global Clinical Trial, and Licensee shall pay the amount invoiced within [* * *] Business Days after the receipt of any such invoice. |
22
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
or other areas of remediation are not, by their nature, reasonably capable of remediation within such [* * *] day period (e.g., due to delays of the Clinical Trial site), then such period shall be reasonably extended. |
(b) Licensee will provide Verastem with copies of all quality oversight or audit reports prepared in connection with any audit that Licensee, its Affiliates or Sublicensees conduct of any Clinical Trial site that Licensee, its Affiliates or Sublicensees have engaged, or are evaluating to potentially engage, to fulfill Licensee’s Development obligations under the Development Plan no later than [* * *] days after receiving or finalizing, as applicable, any such report. |
23
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
are Controlled by Verastem, provided that Licensee’s right to access, review and copy such records shall be limited to such records that are necessary or useful for the Development, Regulatory Approval or Commercialization of Licensed Products in the Territory, and Licensee’s use of such records in connection with applications for Regulatory Approval shall be subject to Licensee’s payment obligations under Section 5.3(b). |
(c) Notwithstanding anything herein to the contrary, Licensee’s use of the Development Data from any Verastem New Clinical Trial shall be subject to Section 5.3(b). |
(b) Licensee shall provide to Verastem for review and comment drafts of all material Regulatory Documents which Licensee plans to submit to a Regulatory Authority, or any Regulatory Documents that could reasonably be expected to have a material impact on the further Development or Regulatory Approval in the Field in the Territory, together with a written English summary thereof, reasonably (but in no event later than [* * *] Business Days or, if Licensee has fewer than [* * *] Business Days to prepare a submission, as soon as reasonably practicable) prior to submission, and shall incorporate any reasonable comments from Verastem that are provided to Licensee before the date of such submission. In addition, Licensee shall notify Verastem of any Regulatory Documents submitted to or received from any Regulatory Authority in the Territory and shall provide Verastem with copies thereof within [* * *] Business Days after submission or receipt of such Regulatory Documents. |
24
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
such meeting or discussion, Licensee shall provide Verastem with a written summary thereof in English promptly, but in no event later than [* * *] days, following such meeting or discussion. |
(i) In the event that Licensee notifies Verastem in writing before enrollment of the first patient in such Verastem New Clinical Trial, Licensee shall be responsible for [* * *] of the costs incurred by Verastem in the conduct of such Verastem New Clinical Trial. Verastem shall invoice Licensee on a [* * *] basis for the amount of foregoing Licensee’s cost burden, and Licensee shall pay the amount invoiced within [* * *] Business Days after the receipt of such invoice. |
(ii) In the event that Licensee notifies Verastem in writing after the enrollment of the first patient in such Verastem New Clinical Trial, but before Verastem’s final data becomes available, Licensee shall be responsible for [* * *] of the costs incurred by Verastem in the conduct of such Verastem New Clinical Trial. Verastem shall invoice Licensee [* * *] of the costs actually incurred by Verastem up to that point and Licensee shall pay the amount invoiced within [* * *] Business Days after the receipt of any such invoice. Thereafter, Verastem shall invoice Licensee on a [* * *] basis for the amount of foregoing Licensee’s cost burden, and |
25
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
Licensee shall pay the amount invoiced within [* * *] Business Days after the receipt of such invoice. |
(iii) In the event that Licensee notifies Verastem in writing after the final data of such Verastem New Clinical Trial is available, Licensee shall be responsible for [* * *] of the costs incurred by Verastem in the conduct of such Verastem New Clinical Trial. Verastem shall invoice Licensee for the amount of foregoing Licensee’s cost burden, and Licensee shall pay the amount invoiced within [* * *] Days after the receipt of such invoice. |
(c) Notwithstanding the foregoing Section 5.3(b), with respect to the [* * *] Clinical Trial, the [* * *] Clinical Trial and the [* * *], Licensee shall be required to notify Verastem in writing by the later of (i) [* * *] days following the Effective Date or (ii) [* * *] days after [* * *] the [* * *] Clinical Trial, the [* * *] Clinical Trial, or the [* * *], as applicable, if Licensee desires to include any Development Data from any such Clinical Trial in any application for Regulatory Approval in the Territory for the purpose of supporting efficacy of any Licensed Product (excluding, for the avoidance of doubt, inclusion of Development Data in supplemental documents for purposes that are unrelated to efficacy, such as mandatory inclusion in the Licensed Product’s safety database). If Licensee so notifies Verastem, then Licensee shall be responsible for [* * *] of the costs incurred by Verastem in the conduct of the [* * *]. Verastem shall invoice Licensee [* * *] of the costs actually incurred by Verastem up to that point and Licensee shall pay the amount invoiced within [* * *] Business Days after the receipt of any such invoice. Thereafter, Verastem shall invoice Licensee on a [* * *] basis for the amount of Licensee’s cost burden, and Licensee shall pay the amount invoiced within [* * *] Business Days after the receipt of such invoice. If Licensee elects to use the Development Data from the [* * *] Clinical Trial, the [* * *] Clinical Trial or the [* * *] after such period, then Sections 5.3(b)(ii) and 5.3(b)(iii) shall apply accordingly. |
(a) Promptly following the Effective Date, but in no event later than [* * *] days thereafter, Licensee and Verastem shall develop and agree in a written agreement to worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed Products, such as safety data sharing and exchange, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). Such Pharmacovigilance Agreement shall describe the obligations of both Parties with respect to the coordination of collection, investigation, reporting and exchange of information between the Parties concerning adverse events or any other safety issue of any significance and product quality and product complaints involving adverse events, in each case with respect to Licensed Products and sufficient to permit each Party and its Affiliates, Third Party Licensees and Sublicensees to comply with its legal obligations with respect thereto. The Pharmacovigilance Agreement shall be promptly updated if required by changes in Applicable Law. Each Party hereby agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, Third Party Licensees and Sublicensees to comply with such obligations. |
26
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
(a) If a Regulatory Authority desires to conduct an inspection or audit of Licensee, its Affiliates, Sublicensees or Subcontractors (including Clinical Trial sites) relating to the Licensed Compound or the Licensed Products, Licensee shall promptly notify Verastem thereof. Verastem shall have the right, but not the obligation, to be present at any such inspection. Licensee shall permit Regulatory Authorities to conduct inspections or audit of Licensee, its Affiliates, Sublicenses or Subcontractors (including Clinical Trial sites) relating to the Licensed Compound or the Licensed Products, and shall ensure that such Affiliates, Sublicensees and Subcontractors permit such inspections or audit. Licensee will provide Verastem with a written summary in English of any findings of a Regulatory Authority following a regulatory audit within [* * *] days following any such inspection or audit, and will provide Verastem with an unredacted copy of any report issued by such Regulatory Authority following such audit. |
(b) If a Regulatory Authority desires to conduct an inspection or audit of Verastem, its Affiliates, Third Party Licensees or Subcontractors (including Clinical Trial sites) relating to the Licensed Compound or the Licensed Products for the Territory, Verastem shall promptly notify Licensee thereof. Licensee shall have the right to request to be present at any such inspection, and Verastem shall consider Licensee’s request in good faith. Verastem shall permit Regulatory Authorities to conduct inspections or audit of Verastem, its Affiliates, Third Party Licensees or Subcontractors (including Clinical Trial sites) relating to the Licensed Compound and/or the Licensed Products, and shall ensure that such Affiliates, Third Party Licensees and Subcontractors permit such inspections or audit. Verastem will provide Licensee with a written summary in English of any findings of a Regulatory Authority following a regulatory audit within [* * *] days following any such inspection or audit, and will provide Licensee with an unredacted copy of any report issued by such Regulatory Authority following such audit. |
27
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
Licensed Product that could have an adverse impact upon other Party’s regulatory status of any Licensed Product, then such Party shall have the right to bring the matter to the attention of the JSC and the Parties shall discuss in good faith a resolution of such concern. Without limiting the foregoing, unless the Parties otherwise agree: (a) Licensee shall not, and shall not permit its Affiliates, Sublicensees or Subcontractors to, communicate with any Regulatory Authority having jurisdiction outside the Territory with respect to any Licensed Product, unless so ordered by such Regulatory Authority, in which case Licensee shall immediately, but in any event within [* * *], notify Verastem of such order; and (b) Licensee shall not, and shall not permit its Affiliates, Sublicensees or Subcontractors to, submit any Regulatory Documents or seek Regulatory Approvals outside the Territory. |
28
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
conditions consistent with the principles set forth on Exhibit H hereto (Supply Agreement Key Terms) and typical for such agreements (the “Supply Agreement”). Verastem shall invoice Licensee for the Licensed Compound and Licensed Product upon delivery and Licensee shall pay the amount invoiced within [* * *] Business Days after its receipt of the invoice. |
29
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
annually within [* * *] days after the end of such Calendar Year a written report that summarizes the Commercialization activities on a Licensed Product-by-Licensed Product basis performed by or on behalf of Licensee, its Affiliates and Sublicensees in the Territory during such Calendar Year. Such report shall contain sufficient detail to enable Verastem to assess Licensee’s compliance with its Commercialization obligations in Section 6.2. [* * *]. Licensee shall provide updates to any such report at each meeting of the JSC, JPT and any Working Group established by the JSC to oversee Commercialization-related activities under this Agreement. |
(a) The Parties recognize that they may benefit from the coordination of certain activities in support of the Commercialization of Licensed Products in and outside the Territory in furtherance of the Global Strategy. As such, the Parties shall coordinate such activities where appropriate, which may include scientific and medical communication and Licensed Product positioning. |
(b) Licensee shall keep Verastem informed on the status of any application for pricing or reimbursement approval for Licensed Products in the Territory, including any discussion with Regulatory Authorities with respect thereto, and shall notify Verastem within [* * *] Business Days of any such status update or discussion. Each Party shall have the right to determine the price of Licensed Products sold in its territory and neither Party shall have the right to direct, control or approve the pricing of Licensed Products in the other Party’s territory. |
30
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
located in any country, jurisdiction or region in the other Party’s territory, or solicit orders from any prospective purchaser located in any country, jurisdiction or region in the other Party’s territory. If a Party, its Affiliates, Third Party Licensees (with respect to Verastem) or Sublicensees (with respect to Licensee) receive any order for Licensed Products for use from a prospective purchaser located in a country, jurisdiction or region in the other Party’s territory, then such Party shall immediately, but in any event within [* * *] hours, refer that order to such other Party and shall not accept any such orders. Neither Party shall, nor permit its Affiliates, Third Party Licensees (with respect to Verastem) or Sublicensees (with respect to Licensee) to, deliver or tender (or cause to be delivered or tendered) any Licensed Products for use in the other Party’s territory. |
Development Milestone Event |
Milestone Payment |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *]
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WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
Each milestone payment set forth above shall be payable only once for the Licensed Products. If any milestone event occurs for the Licensed Products for the [* * *] without one or more of the prior milestone events for the [* * *] occurring for Licensed Products, then Licensee shall make the milestone payment(s) for all such prior, unpaid milestone events for the [* * *] at the same time it is required to pay Verastem for the milestone event that has occurred.
Sales Milestone Threshold |
Milestone Payment |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
Each Sales Milestone Payment will be payable only one-time and only upon the first achievement of the applicable Sales Milestone Event in the Territory, and no amounts would be due for subsequent or repeated achievements. If a Sales Milestone Event is achieved prior to the achievement of the preceding Sales Milestone Event set forth in the relevant chart (i.e., if a lower-listed Sales Milestone Event is achieved before a Sales Milestone Event that is listed higher up in the relevant chart), then upon achievement of the relevant Sales Milestone Event, payments for all preceding Sales Milestone Events set forth in the relevant chart shall become due and payable.
32
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
perpetual, irrevocable and royalty-free, in each case only to the extent that (A) the License with respect to such Licensed Product in the Territory has not been terminated prior to expiration of the applicable Royalty Term and (B) Licensee has paid Verastem all royalties payable with respect to such Licensed Product in the Territory throughout the applicable Royalty Term. |
(d) Payments to Third Parties. Each Party shall be solely responsible for making all payments owed by it to Third Parties, including, with respect to Verastem, the Upstream Licensors (in accordance with the terms of the Upstream License Agreements), and neither Party shall have any obligation to make any such payments on behalf of the other Party. |
33
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
(a) Licensee shall maintain, and shall cause its Affiliates and Sublicensees to maintain, complete and accurate records in sufficient detail to permit Verastem to confirm the accuracy of the amount of royalty payments and other amounts payable under this Agreement, in accordance with Japanese GAAP or International Financial Reporting Standards, consistently applied. Upon reasonable prior notice, such records shall be open during regular business hours for a period of [* * *] years from the creation of individual records for examination by an independent certified public accountant selected by Verastem and reasonably acceptable to Licensee for the purpose of verifying for Verastem the accuracy of the financial reports furnished by Licensee pursuant to this Agreement or of any payments made, or required to be made by Licensee, pursuant to this Agreement. Such audits shall not occur more often than [* * *]. Such accountant shall execute a suitable confidentiality agreement reasonably acceptable to Licensee prior to conducting such audit, and shall not disclose Licensee’s Confidential Information to Verastem, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by Licensee or the amount of payments by Licensee under this Agreement. |
34
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
Licensee will pay any amounts shown to be owed to Verastem but unpaid within [* * *] days after the accountant’s report, plus interest (as set forth in Section 7.5) from the original due date. Verastem shall bear the full cost of such audit unless such audit reveals an underpayment by Licensee of more than [* * *] of the amount actually due for the time period being audited, in which case Licensee shall [* * *]. |
(b) Withholding Tax. The Parties hereby acknowledge and agree that (i) under the Applicable Laws as of the Effective Date no withholding or similar Taxes will be imposed or levied on account of any payment made under this Agreement, and (ii) to the extent that there is a change in Applicable Law at any time during the Term such that withholding or other additional potential Taxes may be imposed or levied on account of the payment of any amounts owed under this Agreement, then the Parties shall use Commercially Reasonable Efforts to mitigate the amount of such Taxes that would be required to be withheld or paid, or to mitigate the effect of such change in Applicable Law. Notwithstanding the foregoing, if Licensee is so required by Applicable Law to deduct and withhold Taxes from a payment due and payable to Verastem hereunder, Licensee shall: (a) promptly notify Verastem of such requirement; (b) make such required deduction and withholding from the corresponding payment; (c) pay to the relevant Governmental Authority (e.g., the applicable taxing authority) the full amount required to be so deducted and withheld; and (d) promptly forward to Verastem an official receipt (or certified copy) or other documentation reasonably acceptable to Verastem evidencing such payment to such Governmental Authority(ies). [* * *]. |
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION (“SEC”). REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
(c) Cooperation. The Parties acknowledge and agree that it is mutual objective and intent to minimize, to the extent feasible under the Applicable Laws, any Taxes payable in connection with this Agreement, and shall reasonably cooperate each other in good faith in accordance with Applicable Laws to minimize any Taxes in connection with this Agreement. |
(b) the Receiving Party may only use any Confidential Information of the Disclosing Party for the purposes of performing its obligations or exercising its rights under this Agreement; and |
(c) a Receiving Party may disclose Confidential Information of the Disclosing Party to: (i) such Receiving Party’s Affiliates, Third Party Licensees (with respect to Verastem) or Sublicensees (with respect to Licensee); and (ii) employees, directors, agents, contractors, consultants and advisors of the Receiving Party and its Affiliates, Third Party Licensees (with respect to Verastem) or Sublicensees (with respect to Licensee), in each case to the extent reasonably necessary for the purposes of, and for those matters undertaken pursuant to, this Agreement; provided that such Persons are bound by legally enforceable obligations to maintain the confidentiality of the Disclosing Party’s Confidential Information in a manner consistent with the confidentiality provisions of this Agreement; and provided further that each Party shall remain responsible for any failure by its Affiliates, Third Party Licensees (with respect to Verastem) or Sublicensees (with respect to Licensee), and its and its Affiliates’, Third Party Licensees’ (with respect to Verastem) or Sublicensees’ (with respect to Licensee) respective employees, directors, agents, consultants, advisors, and contractors, to treat such Confidential Information as required under this Section 8.1 as if such Affiliates, Third Party Licensees (with respect to Verastem) or Sublicensees (with respect to Licensee) employees, directors, agents, consultants, advisors and contractors were Parties directly bound to the requirements of this Section 8.1. |
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(b) is generally available to the public before its receipt from the Disclosing Party; |
(c) became generally available to the public or otherwise part of the public domain after its disclosure by the Disclosing Party and other than through any act or omission of the Receiving Party (or any Person to whom the Receiving Party disclosed such Confidential Information) in breach of this Agreement; |
(d) is subsequently disclosed to the Receiving Party or any of its Affiliates without obligation of confidentiality by a Third Party who may rightfully do so and is not under a conflicting obligation of confidentiality to the Disclosing Party; or |
(e) is developed by the Receiving Party or any of its Affiliates independently and without use of or reference to any Confidential Information received from the Disclosing Party, as documented by the Receiving Party’s business records. |
No combination of features or disclosures shall be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the Receiving Party, unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the Receiving Party.
(b) disclosure of this Agreement, its terms and the status and results of Development or Commercialization activities to actual or bona fide potential investors, acquirors, (sub)licensees, lenders and other financial or commercial partners solely for the purpose of evaluating or carrying out an actual or potential investment, acquisition, (sub)license, debt transaction or collaboration; provided that in each such case on the condition that such Persons are bound by written, binding obligations of confidentiality and non-use consistent with this Agreement; |
(c) such disclosure is required by judicial or administrative process, provided that in such event such Party shall promptly notify the other Party in writing of such required disclosure and provide the other Party an opportunity to challenge or limit the disclosure obligations. Confidential Information that is disclosed by judicial or administrative process shall |
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remain otherwise subject to the confidentiality and non-use provisions of this Article 8, and the Party disclosing Confidential Information pursuant to Applicable Laws or court order shall (i) take all steps reasonably necessary, including seeking of confidential treatment or a protective order, to ensure the continued confidential treatment of such Confidential Information (ii) limit disclosure of such Confidential Information only to that which is required to be disclosed by the applicable Governmental Authority; |
(d) such disclosure is by Verastem and is required to comply with its obligations to one or more Upstream Licensors; or |
(e) disclosure pursuant to Sections 8.4 and 8.6. |
Notwithstanding the foregoing, in the event a Party is required or permitted to make a disclosure of the other Party’s Confidential Information pursuant to Section 8.3(a), it will, except where impracticable, give reasonable advance notice to the other Party of such disclosure and use Commercially Reasonable Efforts to secure confidential treatment of such information. In any event, each Party agrees to take all reasonable action to avoid disclosure of Confidential Information of the other Party hereunder.
Nothing in Sections 8.1 or 8.3 shall limit either Party in any way from disclosing to any Third Party such Party’s U.S. or foreign income tax treatment and the U.S. or foreign income tax structure of the transactions relating to such Party that are based on or derived from this Agreement, as well as all materials of any kind (including opinions or other tax analyses) relating to such tax treatment or tax structure, except to the extent that nondisclosure of such matters is reasonably necessary in order to comply with applicable securities laws.
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any trademarks and corporate or trade names of Licensee shall not be impaired, in a manner consistent with best practices used by Verastem with respect to its other collaborators, and in a manner consistent with Licensee’s brand usage policies. |
(e) Other than the press release set forth in Exhibit C and the public disclosures permitted by Section 8.6(b), the Parties agree that the portions of any other news release or other public announcement relating to this Agreement or the performance hereunder that would disclose information other than that already in the public domain, shall first be reviewed and approved by both Parties (with such approval not to be unreasonably withheld or delayed), except as required by Applicable Laws. |
(f) The Parties agree that after a disclosure pursuant to Section 8.6(d) or issuance of a press release (including the initial press release) or other public announcement pursuant to Section 8.6(a) or Section 8.6(b) that has been reviewed and approved by the other |
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Party, the disclosing Party may make subsequent public disclosures reiterating such information without having to obtain the other Party’s prior consent and approval. |
(g) Each Party shall have the right to use the other Party’s name and logo in presentations, its website, collateral materials and corporate overviews to describe the collaboration relationship, as well as in taglines of press releases issued pursuant to this Section 8.6; provided that each Party will use the other Party’s corporate name only in such manner that the distinctiveness, reputation, and validity of any trademarks and corporate or trade names of the other Party shall not be impaired, in a manner consistent with best practices used by the Party for its other collaborators, and in a manner consistent with the other Party’s brand usage policies. |
9.1 Representations, Warranties of Each Party. Each Party represents and warrants to the other Party as of the Effective Date that: |
(a) it has the full right, power and authority to enter into this Agreement and to perform its obligations hereunder; |
(b) this Agreement has been duly executed by it and is legally binding upon it, enforceable in accordance with its terms, and does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material Applicable Laws or regulation of any court, governmental body or administrative or other agency having jurisdiction over it; and |
(c) there are no legal claims, judgments or settlements against or owed by it or any of its Affiliates, or pending or, to its present knowledge, threatened, legal claims or litigation, in each case, relating to antitrust, anti-competition, anti-bribery or corruption violations. |
9.2 Representations and Warranties of Verastem. Verastem represents and warrants to Licensee that as of the Effective Date: |
(a) subject to Section 2.5, it has the right under the Verastem IP to grant the License to Licensee, and it has not granted any license or other right under the Verastem IP that is inconsistent with the License; |
(b) it has not received any written notice from any Third Party asserting or alleging that the Development of the Licensed Compound or Licensed Product prior to the Effective Date infringed or misappropriated the intellectual property rights of such Third Party; |
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(d) to Verastem’s knowledge, there are no material safety issues with respect to the Licensed Compound or Licensed Product in the Field. |
9.4 Representations and Warranties of Licensee. Licensee represents and warrants to Verastem that as of the Effective Date: |
(a) Licensee and its Affiliates are not, and has not been, debarred or disqualified by any Regulatory Authority; |
(b) Verastem will conduct the Global Clinical Trial in the Territory in strict adherence with the study design set forth in the protocol for such Global Clinical Trial; and |
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debarred by any Regulatory Authority, or, to Licensee’s knowledge, is the subject of debarment proceedings by a Regulatory Authority; |
(b) Licensee will conduct its Clinical Trials under the Development Plan in strict adherence with the study design set forth in the protocol for such Clinical Trial, as may be amended from time to time, and will comply with the statistical analysis plan implemented in connection therewith; and |
(c) Licensee will only engage Clinical Trial sites that conduct all Clinical Trials in compliance with Applicable Laws in the relevant jurisdiction, including GCP and the ICH Guidelines as applicable. |
(a) Notwithstanding anything to the contrary in this Agreement, Licensee agrees that: |
(ii) it shall not, in the performance of this Agreement, directly or indirectly, make any payment, or offer or transfer anything of value, or agree or promise to make any payment or offer or transfer anything of value, to a government official or government employee, to any political party or any candidate for political office or to any other Third Party with the purpose of influencing decisions related to either Party or its business in a manner that would violate Anti-Corruption Laws; |
(i) has taken any action in violation of any applicable Anti-Corruption Laws; or |
(ii) has corruptly offered, paid, given, promised to pay or give, or authorized the payment or gift of anything of value, directly or indirectly, to any Public Official (as defined in Section 9.7(d)), for the purposes of: |
(1) influencing any act or decision of any Public Official in his or her official capacity; |
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(2) inducing such Public Official to do or omit to do any act in violation of his or her lawful duty; |
(3) securing any improper advantage; or |
(4) inducing such Public Official to use his or her influence with a government, Governmental Authority, or commercial enterprise owned or controlled by any government (including state-owned or controlled veterinary, laboratory or medical facilities) in obtaining or retaining any business whatsoever. |
(c) Licensee further represents and warrants that, as of the Effective Date, none of the officers, directors or employees of Licensee or of any of its Affiliates or agents acting on behalf of Licensee or any of its Affiliates, in each case that are employed or reside outside the United States, is a Public Official. |
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reasonable attorneys’ fees and costs) incurred in connection with any claims, demands, actions or other proceedings by any Third Party (individually and collectively, “Losses”) to the extent arising from (a) the Exploitation of the Licensed Compound or Licensed Products by or on behalf of Licensee or any of its Affiliates, Sublicensees or Subcontractors, including product liability claims (other than product liability claims resulting from Verastem’s breach of its obligations under the Supply Agreement), (b) the gross negligence or willful misconduct of Licensee or its Affiliates, Sublicensees or Subcontractors, (c) Licensee’s breach of any of its representations or warranties made in or pursuant to this Agreement or any Licensee covenants or obligations set forth in or entered into pursuant to this Agreement, or (d) failure of Licensee or its Affiliates, Sublicensees or Subcontractors to abide by any Applicable Laws, in each case of clauses (a) through (d) above, except to the extent such Losses arise out of a Verastem Indemnitee’s gross negligence or willful misconduct or material failure to abide by any Applicable Laws. |
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resolution of the dispute pursuant to Article 13, the Parties may conduct separate defenses of such claims, with each Party retaining the right to claim indemnification from the other Party in accordance with Sections 10.1 or 10.2 upon resolution of the underlying claim. |
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11.1(a)(iii) above. Licensee shall take (and cause its Affiliates, Sublicensees, and Subcontractors, including their respective employees, agents, and contractors to take) such further actions reasonably requested by Verastem to evidence such assignment and to assist Verastem in obtaining patent and other intellectual property rights protection for such Inventions. Licensee shall obligate its Affiliates, Sublicensees and Subcontractors to assign all such jointly-invented Inventions to Licensee (or directly to Verastem) so that Licensee can comply with its obligations under this Section 11.1(c), and Licensee shall promptly obtain such assignment. |
(iii) [* * *]. |
(b) Licensee Patents. As between the Parties, Licensee shall have the sole right to control the Patent Prosecution of all Licensee Patents throughout the world, at Licensee’s own cost and expense. |
(c) Cooperation. Each Party shall provide the other Party all reasonable assistance and cooperation in the Patent Prosecution efforts under this Section 11.2, including providing any necessary powers of attorney and executing any other required documents or instruments for such prosecution. |
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WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SEC.
action alleging the invalidity, unenforceability or non-infringement of any Verastem Patents and Licensee Patents (collectively “Product Infringement”). For clarity, Product Infringement excludes any adversarial Patent Prosecution proceedings. |
(i) Verastem shall have the first right, in its sole discretion, to bring and control any legal action to enforce Verastem Patents against any Product Infringement in the Territory at its own expense as it determines appropriate, provided that Verastem notifies Licensee of any such legal action reasonably in advance, and reasonably considers Licensee’s comments with respect thereto. In the event Verastem is unable or unwilling to bring or control such legal action against such Product Infringement in the Territory within [* * *] after the date of notice of such Patent Infringement, Licensee, subject to any applicable restrictions under the Upstream License Agreements, shall have the right, but not the obligation to, take any legal action, at Licensee’s own cost and expense, as Licensee deems appropriate to prevent or enjoin such Product Infringement in the Territory. |
(ii) Licensee shall have the first right to bring and control any legal action to enforce Licensee Patents against any Product Infringement in the Territory at its own expense as it reasonably determines appropriate, and in the event Licensee is unable or unwilling to bring or control the legal action against such Product Infringement in the Territory within [* * *] after the date of notice of such Patent Infringement, Verastem may, but not be obligated to, take any legal action, at Verastem’s own expense, as Verastem deems appropriate to prevent or enjoin such Product Infringement in the Territory. |
(c) Cooperation. At the request of the Party bringing an action related to Product Infringement, the other Party shall provide reasonable assistance in connection therewith, including by executing reasonably appropriate documents, cooperating in discovery and joining as a party to the action if required by Applicable Law to pursue such action, at each such Party’s sole cost and expense. |
(d) Recoveries. Any recoveries resulting from enforcement action relating to a claim of Product Infringement in the Territory shall be first applied against payment of each Party’s costs and expenses in connection therewith. [* * *]. |
(a) Notice. If any Licensed Compound or Licensed Product used or sold by Licensee, its Affiliates or Sublicensees in the Territory becomes the subject of a Third Party’s claim or assertion of infringement of a Patent Right or other rights in the Territory that are owned or controlled by such Third Party, then the Party becoming aware of such claim or assertion shall promptly notify the other Party within [* * *] days after receipt of such claim or assertion and such notice shall include a copy of any summons or complaint (or the equivalent thereof) received regarding the foregoing. Thereafter, the Parties shall promptly meet to consider the claim or |
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assertion and the appropriate course of action and may, if appropriate, agree on and enter into a “common interest agreement” wherein the Parties agree to their shared, mutual interest in the outcome of such potential dispute. The Parties shall assert and not waive the joint defense privilege with respect to any communications between the Parties in connection with the defense of such claim or assertion. |
(b) Defense. Licensee shall be solely responsible for the defense of any such infringement claims brought against Licensee, at Licensee’s cost and expense and Verastem shall provide reasonable assistance to Licensee at Verastem’s cost and expense; provided that Licensee shall not agree to any settlement, consent to judgment or other voluntary final disposition in connection with such defense action without Verastem’s consent (such consent not to be unreasonably withheld, conditioned or delayed) if such settlement, consent to judgment or other voluntary final disposition would (1) result in the admission of any liability or fault on behalf of Verastem, (2) result in or impose any payment obligations upon Verastem, or (3) subject Verastem to an injunction or otherwise limit Verastem’s ability to take any actions or refrain from taking any actions under this Agreement or with respect to any Licensed Compound or Licensed Product. Licensee shall keep Verastem informed on the status of such defense action, and Verastem shall, at its own expense, (i) provide reasonable support to Licensee upon Licensee’s reasonable request; and (ii) have the right, but not the obligation, to participate or be separately represented in such defense action at its sole option. |
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(ii) Licensee shall execute any documents required in the reasonable opinion of Verastem to be entered as a “registered user” or recorded licensee of Verastem’s Licensed Trademarks or to be removed as registered user or licensee thereof. |
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or in association with any other Person, commences a legal action challenging the validity, enforceability or scope of any Verastem Patent that is or was included in the License at any time during the Term anywhere in the world. |
(e) Full Force and Effect During Notice Period. This Agreement shall remain in full force and effect until the expiration of the applicable termination notice period. For clarity, if any milestone event is achieved during the termination notice period, then the corresponding milestone payment is accrued and Licensee shall remain responsible for the payment of such milestone payment even if the due date of such milestone payment may come after the effective date of the termination. |
(b) Regulatory Approval. Licensee shall assign to Verastem or a Third Party designated by Verastem all Regulatory Approvals for the Licensed Products in the Territory, at Licensee’s cost and expense. In addition, upon Verastem’s written request, Licensee shall, at its cost and expense, provide to Verastem copies of all tangible Development Data and Regulatory Documents Controlled by Licensee. The Parties shall discuss and establish appropriate arrangements with respect to safety data exchange, provided that Verastem will assume all safety and safety database activities no later than [* * *] after the termination hereof. |
(c) Product Marks. Except with respect to the Licensed Trademarks, which, for the avoidance of doubt, shall remain solely owned by Verastem during and following the Term, Licensee shall transfer and assign, and shall ensure that its Affiliates and Sublicensees transfer and assign, to Verastem, at no cost to Verastem, all Product Marks relating to any Licensed Product and any applications therefor (excluding any such marks that include, in whole or part, any corporate name or logos of Licensee or its Affiliates or Sublicensees). Verastem and its Affiliates |
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and licensees shall have the right to use other identifiers specific to any Licensed Product (e.g., Licensee compound identifiers). Licensee shall also transfer to Verastem any in-process applications for trademarks for any Licensed Product. |
(e) Wind Down and Transition. Licensee shall be responsible, at its own cost and expense, for the wind-down of Licensee’s, its Affiliates’ and its Sublicensees’ Development and Commercialization activities for the Licensed Compound and Licensed Products. Licensee shall, and shall cause its Affiliates and Sublicensees to, reasonably cooperate with Verastem to facilitate orderly transition of the Development and Commercialization of the Licensed Compound and Licensed Products to Verastem or its designee, including (i) assigning or amending as appropriate, upon request of Verastem, any agreements or arrangements with Third Party vendors (including distributors) to Develop, promote, distribute, sell or otherwise Commercialize the Licensed Compound or Licensed Products or, to the extent any such Third Party agreement or arrangement is not assignable to Verastem, reasonably cooperating with Verastem to arrange to continue to provide such services for a reasonable time after termination; and (ii) to the extent that Licensee or its Affiliate is performing any activities described above in (i), reasonably cooperating with Verastem to transfer such activities to Verastem or its designee and continuing to perform such activities on Verastem’s behalf for a reasonable time after termination until such transfer is completed. |
(f) Ongoing Clinical Trial. If, at the time of such termination, Licensee or its Affiliates are conducting any Clinical Trials, then, on a Clinical Trial-by-Clinical Trial basis, and in Verastem’s sole discretion: |
(i) If Verastem elects to have such Clinical Trial transferred to Verastem, then Licensee shall fully cooperate, and shall ensure that its Affiliates fully cooperate, with Verastem to transfer the conduct of such Clinical Trial to Verastem or its designees effective as of [* * *] after the termination effective date, and Verastem shall assume responsibility for the conduct of such transferred Clinical Trial after the effective date of such transfer, provided that Licensee shall bear the cost and expense of such Clinical Trial until the effective date of such transfer; or |
(ii) If Verastem elects not to have such Clinical Trial transferred to Verastem, then Licensee shall, at its sole cost and expense, orderly wind-down the conduct of any such Clinical Trial that is not assumed by Verastem under clause (i) above. |
(g) Return of Confidential Information. At Verastem’s election, Licensee shall return (at Verastem’s expense) or destroy all tangible materials comprising, bearing or containing any Confidential Information of Verastem that are in Licensee’s or its Affiliates’ or |
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Sublicensees’ possession or control and provide written certification of such destruction except to the extent that Licensee is required to retain such materials by Applicable Laws; provided that Licensee may retain one (1) copy of such Confidential Information for its legal archives, and provided further, that Licensee shall not be required to destroy electronic files containing such Confidential Information that are made in the ordinary course of its business information back-up procedures pursuant to its electronic record retention and destruction practices that apply to its own general electronic files and information. Any Confidential Information retained by Licensee pursuant to this Section 12.3(g) shall remain subject to Licensee’s confidentiality obligations in accordance with Article 8. |
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12.8 Termination of Upstream License Agreements. Upon any termination of a given Upstream License Agreement, whether with respect to the Territory or in its entirety (except as caused by Licensee’s, its Affiliates’, or its Sublicensees’ breach of this Agreement or the applicable Upstream License Agreement), Verastem shall use Commercially Reasonable Efforts to put Licensee in contact with the Upstream Licensor for purposes of Licensee negotiating a direct license with such Upstream Licensor in the Territory, provided that Verastem shall not be required to incur any costs or pay any amounts in connection therewith. |
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industry knowledge relevant to the particular dispute. Each Party shall promptly select one (1) Arbitrator each, which selections shall in no event be made later than [* * *] days after receipt of the Arbitration Notice. The third Arbitrator shall be chosen promptly by mutual agreement of the Arbitrators chosen by the Parties, but in no event later than [* * *] days after the date that the last of such Arbitrators was appointed. |
(c) The Arbitrators’ decision and award shall be made within [* * *] days of the filing of the arbitration demand, and the Arbitrators shall agree to comply with this schedule before accepting appointment. However, this time limit may be extended by agreement of the Parties or by the Arbitrators. The Arbitrators shall be authorized to award compensatory damages, but shall not be authorized to reform, modify or materially change this Agreement. The Arbitrators shall, within [* * *] days after the conclusion of the hearing, issue a written award and statement of decision describing the material facts and the grounds for the conclusions on which the award is based, including the calculation of any damages awarded. The decision of the Arbitrators shall be final, conclusive and binding on the Parties and enforceable by any court of competent jurisdiction. |
(d) Each Party shall bear its own costs and expenses (including legal fees and expenses) relating to the arbitration proceeding, except that the fees of the Arbitrators and other related costs of the arbitration shall be shared equally by the Parties, unless the Arbitrators determine that a Party has incurred unreasonable expenses due to vexatious or bad faith positions taken by the other Party, in which event the Arbitrators may make an award of all or any portion of such expenses (including legal fees and expenses) so incurred. |
(e) The Arbitrators shall be required to render the decision in writing and to comply with, and the award shall be limited by, any express provisions of this Agreement relating to damages or the limitation thereof. No Arbitrator shall have the power to award punitive damages under this Agreement regardless of whether any such damages are contained in a proposal, and such award is expressly prohibited. |
(f) Unless the Parties otherwise agree in writing, during the period of time that any arbitration proceeding is pending under this Agreement, the Parties shall continue to comply with all those terms and provisions of this Agreement that are not the subject of the pending arbitration proceeding. |
(g) All arbitration proceedings and decisions of the Arbitrators under this Section 13.3 shall be deemed Confidential Information of both Parties under Article 8. The arbitration proceedings shall take place in [* * *]. The language of the arbitration proceeding shall be in English. |
(h) Notwithstanding the foregoing, any dispute, controversy or claim relating to the scope, validity, enforceability or infringement of any Patent Rights or trademark rights shall be submitted to a court of competent jurisdiction in the country in which such Patent Rights or trademark rights were granted or arose. Nothing in this Section 13.3 will preclude either Party |
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from seeking equitable relief or interim or provisional relief from a court of competent jurisdiction, including a temporary restraining order, preliminary injunction or other interim equitable relief, concerning a dispute either prior to or during any arbitration if necessary to protect the interests of such Party or to preserve the status quo pending the arbitration proceeding. |
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unenforceable provision(s) with valid, legal and enforceable provision(s) that, insofar as practical, implement the purposes of this Agreement. |
If to Verastem:
Verastem, Inc.
117 Kendrick Street, #500,
Needham, MA 02494
USA
Attn: President and CEO
with a copy to:
Verastem, Inc.
117 Kendrick Street, #500,
Needham, MA 02494
USA
Attn: COO
If to Licensee:
Yakult Honsha Co., Ltd.
6F Ginza-Kobiki Bldg.
16-21, Ginza 7-Chome
Chuo-Ku, Tokyo, 104-0061
Japan
Attn: Head of Pharmaceutical Division
with a copy to:
Yakult Honsha Co., Ltd.
3F Ginza-Kobiki Bldg.
16-21, Ginza 7-Chome
Chuo-Ku, Tokyo, 104-0061
Japan
Attn: Head of Pharmaceutical Business Management & Licensing Department
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or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given: (a) when delivered if personally delivered or sent by electronic mail or facsimile on a Business Day (or if delivered or sent on a non-Business Day, then on the next Business Day); (b) on the Business Day after dispatch if sent by nationally-recognized overnight courier; or (c) on the fifth Business Day following the date of mailing if sent by mail.
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any such right, and any single or partial exercise of any particular right by any Party will not exhaust the same or constitute a waiver of any other right provided in this Agreement. |
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{Signature Page Follows}
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In Witness Whereof, the Parties intending to be bound have caused this License and Collaboration Agreement to be executed by their duly authorized representatives as of the Effective Date.
Verastem, Inc.Yakult Honsha Co., Ltd.
By: /s/ Robert ForresterBy:/s/ Takashige Negishi
Name: Robert ForresterName: Takashige Negishi
Title: President & CEOTitle: President and Representative Director
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Exhibit A:Verastem Patents
Exhibit B:Structure of Licensed Compound
Exhibit C:Joint Press Release
Exhibit D: Diligence Obligations
Exhibit E:Development Plan
Exhibit F:Licensed Trademarks
Exhibit G:Synopsis of the [* * *]
Exhibit HSupply Agreement Key Terms
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Exhibit A
Verastem Patents
Attorney Docket |
Application # |
Filing Date |
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Issue Date |
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Exhibit B
Structure of Licensed Compound
[* * *]
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Exhibit C
Joint Press Release
Verastem Oncology and Yakult Honsha Co., Ltd. Sign Exclusive License Agreement for the Development and Commercialization of Duvelisib in Japan
̶ Verastem to Receive Upfront Payment of $10 Million USD,Then Eligible to Receive Up To $90 Million USD in Future Milestones, Plus Royalties ̶
̶ Yakult Obtains Rights to First-in-class Oral Dual Inhibitor of Phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma (PI3K-δ,γ), Duvelisib for Oncology Indications in Japan ̶
BOSTON, MA, USA and TOKYO, JAPAN – May [XX], 2018 – Verastem, Inc. (President and CEO: Robert Forrester, NASDAQ: VSTM) and Yakult Honsha Co., Ltd. (President: Takashige Negishi, Tokyo: 2267), today announced their entry into an exclusive licensing agreement for Yakult to develop and commercialize Verastem’s duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, for the treatment, prevention or diagnosis of all oncology indications in Japan. Verastem’s New Drug Application (NDA) for duvelisib is currently under review with the U.S. Food and Drug Administration (FDA) and is seeking full approval for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL). On April 9, 2018, Verastem announced that the FDA had accepted the NDA for filing with Priority Review.
Under the terms of the agreement, Verastem will receive a one-time upfront payment of $10 million from Yakult. Verastem is eligible to receive up to an additional $90 million if certain future pre-specified development and commercialization milestones are successfully achieved by Yakult, plus double-digit royalties based on future net sales of duvelisib in Japan. In exchange, Yakult will receive exclusive rights to develop and commercialize duvelisib in Japan, at its own cost and expense. Yakult will also fund certain global development costs on a pro-rata basis. Verastem will retain all rights to duvelisib outside of Japan.
“In Japan, current therapies to treat CLL/SLL and FL are extremely limited and duvelisib has robust clinical data supporting its efficacy and safety in both indications, which we can build upon,” said Masanori Ito, Head of Pharmaceutical Business Division/Managing Executive Officer, Member of the Board of Yakult. “We are eager to collaborate with Verastem to develop duvelisib in these initial hematologic malignancies, and then plan to later expand development to include the additional indications of PTCL and DLBCL. We believe this collaboration underscores our commitment to innovation, growing our oncology franchise, and commercializing medicines that positively impact the lives of patients in Japan.”
“Following extensive due diligence, we have chosen Yakult as our duvelisib development and commercialization partner in Japan,” said Robert Forrester, President and Chief Executive Officer of Verastem. “Yakult is an established oncology leader in Japan that successfully markets several branded anti-cancer therapies, including Elplat® and Campto®. This agreement is an important, validating
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achievement for both duvelisib and Verastem Oncology and speaks to the significant global potential of this novel therapeutic for a broad range of hematologic malignancies. We look forward to working with the world-class development, regulatory and commercial teams at Yakult as they advance oral duvelisib toward commercialization in Japan.”
Duvelisib is a first-in-class investigational oral, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO™, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO™, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.
About Verastem Oncology
Verastem, Inc. (Nasdaq:VSTM), operating as Verastem Oncology, is a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients. Verastem Oncology is currently developing duvelisib, a dual inhibitor of PI3K-delta and PI3K-gamma, which has successfully met its primary endpoint in a Phase 2 study in indolent Non-Hodgkin Lymphoma (iNHL) and a Phase 3 clinical trial in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. In addition, Verastem Oncology is developing the FAK inhibitor defactinib, which is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types, including pancreatic cancer, ovarian cancer, non-small-cell lung cancer (NSCLC), and mesothelioma. Verastem Oncology’s product candidates seek to treat cancer by modulating the local tumor microenvironment and enhancing anti-tumor immunity. For more information, please visit www.verastem.com.
About Yakult Honsha Co., Ltd.
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Yakult is a leading Japanese company focused on the development and marketing of pharmaceuticals, foods, beverages, and cosmetics. With respect to its pharmaceutical business, Yakult has a strong presence in development and commercialization of the therapeutic products in the field of oncology. The company, led by Takashige Negishi, in 2017 recorded ¥378.3 Billion Revenues.
For more information on Yakult, visit: http://www.yakult.co.jp/english/index.html or view the
following company profile:
http://www.yakult.co.jp/english/pdf/profile2017-2018_en.pdf
Verastem, Inc. forward-looking statements notice:
This press release includes forward-looking statements about Verastem Oncology’s strategy, future plans and prospects, including statements regarding the development and activity of Verastem Oncology’s investigational product candidates, including duvelisib and defactinib, and Verastem Oncology’s PI3K and FAK programs generally, the potential to receive milestone and royalty payments under the agreement with Yakult, the structure of our planned and pending clinical trials, Verastem Oncology’s financial guidance and the timeline and indications for clinical development and regulatory submissions. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks that approval of Verastem Oncology’s New Drug Application for duvelisib in any jurisdiction will not occur on the expected timeframe or at all, including by the U.S. Food and Drug Administration’s target action date; that a filing of a European Marketing Application may not be achieved in fiscal year 2019 or at all; that partnerships or collaborations for the development of duvelisib outside of the United States may not be successful; that even if data from clinical trials is positive, regulatory authorities may require additional studies for approval or may approve for indications or patient populations that are not as broad as intended and the product may not prove to be safe and effective or may require labeling with use or distribution restrictions; that the preclinical testing of Verastem Oncology’s product candidates and preliminary or interim data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials; that the full data from the DUO study will not be consistent with the previously presented results of the study; that data may not be available when expected, including for the Phase 3 DUO study; that the degree of market acceptance of product candidates, if approved, may be lower than expected; that the timing, scope and rate of reimbursement for our product candidates is uncertain; that there may be competitive developments affecting our product candidates; that data may not be available when expected; that enrollment of clinical trials may take longer than expected; that our product candidates will cause unexpected safety events or result in an unmanageable safety profile as compared to their level of efficacy; that duvelisib will be ineffective at treating patients with lymphoid malignancies; that Verastem Oncology will be unable to successfully initiate or complete the clinical development and eventual commercialization of its product candidates; that the development and commercialization of Verastem Oncology’s product candidates will take longer or cost more than planned; that Verastem Oncology may not have sufficient cash to fund its contemplated operations; that Verastem Oncology or Infinity
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Pharmaceuticals, Inc. will fail to fully perform under the duvelisib license agreement; that Verastem Oncology may be unable to make additional draws under its debt facility or obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity, debt financing or otherwise; that Verastem Oncology will not pursue or submit regulatory filings for its product candidates, including for duvelisib in patients with CLL/SLL or iNHL; and that Verastem Oncology’s product candidates will not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients. Other risks and uncertainties include those identified under the heading "Risk Factors" in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 as filed with the Securities and Exchange Commission (SEC) on March 13, 2018 and in any subsequent filings with the SEC. The forward-looking statements contained in this press release reflect Verastem Oncology’s views as of the date hereof, and the Company does not assume and specifically disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
Contact:
Verastem Oncology, Inc.
Marianne M. Lambertson
Vice President, Corporate Communications
Investor Relations/Public Relations
+1 781-292-4273
mlambertson@verastem.com
References
1 Winkler D.G., Faia K.L., DiNitto J.P. et al. PI3K-delta and PI3K-gamma inhibition by IPI-145 abrogates immune responses and suppresses activity in autoimmune and inflammatory disease models. Chem Biol 2013; 20:1-11.
2 Reif K et al. Cutting Edge: Differential Roles for Phosphoinositide 3 kinases, p110-gamma and p110-delta, in lymphocyte chemotaxis and homing. J Immunol 2004:173:2236-2240.
3 Schmid M et al. Receptor Tyrosine Kinases and TLR/IL1Rs Unexpectedly activate myeloid cell PI3K, a single convergent point promoting tumor inflammation and progression. Cancer Cell 2011;19:715-727.
4 www.clinicaltrials.gov, NCT02004522
5 www.clinicaltrials.gov, NCT01882803
6 www.clinicaltrials.gov, NCT02783625, NCT02158091
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Exhibit D
Diligence Obligations
Type |
Description of obligation |
Date required by Licensee to meet obligation |
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Exhibit E
Development Plan
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Exhibit F
Licensed Trademarks
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Exhibit G
Synopsis of the [* * *] Study
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Exhibit H
Supply Agreement Key Terms
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