EX-10.1 2 d317232dex101.htm DRUG DEVELOPMENT PARTNERSHIP AND LICENSE AGREEMENT Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. DRUG DEVELOPMENT PARTNERSHIP AND LICENSE...
Exhibit 10.1
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
DRUG DEVELOPMENT PARTNERSHIP AND LICENSE AGREEMENT
FOR CUDC-906 AND CUDC-908
THIS DRUG DEVELOPMENT PARTNERSHIP AND LICENSE AGREEMENT (the “Agreement”) is entered into as of February 24, 2012 (the “Effective Date”) by and between CURIS, INC., a corporation organized under the laws of the State of Delaware, USA, having its principal offices at 0 Xxxxxxx Xxxx, Xxxxxxxxx, XX 00000, XXX (“Curis”), and GUANGZHOU BEBETTER MEDICINE TECHNOLOGY CO, LTD., a company organized under the laws of the People’s Republic of China, having its principal offices at Xxxx X000, Xxxxxx X, Xxxxxxxxx International Business Incubator, 0 Xxxxxx Xxxx, Xxxxxxxxx Xxxxxxx Xxxx, Xxxxxxxxx 000000, People’s Republic of China (“GBMT”).
1. | DEFINITIONS. |
1.1 “Affiliate” shall mean any company or other business entity controlled by, controlling, or under common control with a party hereto. For the purpose of this definition, a business entity shall be deemed to “control” another business entity, if it owns directly or indirectly, more than 50% of the outstanding voting securities, capital stock, or other comparable equity or ownership interest of such business entity, or exercises equivalent influence over such entity.
1.2 “C.F.R.” shall mean the United States Code of Federal Regulations.
1.3 “cGCP” shall mean current good clinical practices as established by the SFDA, as amended from time to time.
1.4 “cGLP” shall mean: (a) in the case of preclinical research and development activities with respect to a Compound or Product (including, without limitation, the CUDC-908 IND-Enabling Activities), current good laboratory practices, as set forth in 21 C.F.R. Part 58 and as interpreted by relevant ICH guidelines; and (b) in all other cases, current good laboratory practices as established by the SFDA; in each case, as amended from time to time.
1.5 “cGMP” shall mean: (a) in the case of preclinical research and development activities with respect to a Compound or Product (including, without limitation, the CUDC-908 IND-Enabling Activities), the current good manufacturing practices and standards for the production of drugs and finished pharmaceuticals, as set forth in 21 C.F.R. Parts 210 and 211 and as interpreted by relevant ICH guidelines; and (b) in all other cases, current good manufacturing practices as established by the SFDA; in each case, as amended from time to time.
1.6 “China” shall mean the People’s Republic of China.
1.7 “CMC” shall mean chemistry, manufacturing and controls information.
1.8 “Commercially Reasonable Efforts” shall mean, with respect to GBMT’s under this Agreement to develop or obtain Regulatory Approval for Products in the GBMT Territory, the level of efforts required to carry out such obligation in a manner consistent with the efforts a pharmaceutical or biotechnology company typically devotes to a product of similar market potential, resulting from its own research efforts, at a similar stage in its development or product life.
1.9 “Compound(s)” shall mean CUDC-906 and/or CUDC-908, as applicable.
1.10 “Confidential Information” shall have the meaning provided in Section 8.1.
1.11 “Control” or “Controlled” shall mean, with respect to any information, Patents or other intellectual property rights, possession by an entity of the ability (whether by ownership, license or otherwise) to grant access to, to grant use of, or to grant a license or a sublicense of or under such information, Patents or intellectual property rights without violating the terms of any agreement or other arrangement with any Third Party.
1.12 “CQ/Curis Agreement” shall mean that certain Inventions, Non-Disclosure and Non-Competition Agreement between Curis and Changgeng Qian, M.D., Ph.D., dated July 2, 2001.
1.13 “CUDC-906” shall mean Curis’ multi-target HDAC and PI3K inhibitor known as CUDC-906, having the chemical structure set forth in Exhibit A hereto.
1.14 “CUDC-908” shall mean Curis’ multi-target HDAC and PI3K inhibitor known as CUDC-908, having the chemical structure set forth in Exhibit B hereto.
1.15 “CUDC-908 IND-Enabling Activities” shall have the meaning provided in Section 4.2(a).
1.16 “Curis Invention” shall mean any Invention made solely by one or more employees or contractors of Curis.
1.17 “Curis Know-How” shall mean Information with respect to Compound and/or Product that is Controlled by Curis as of the Effective Date or during the Term and that is necessary or useful for the development, manufacture, use or sale of Compounds or Products in the Field. For the avoidance of doubt, Curis Know-How excludes Information relating to any pharmacologically or therapeutically active ingredient other than a Compound.
1.18 “Curis Non-Assert Patents” shall mean all Patents Controlled by Curis as of the Effective Date or during the Term in the GBMT Territory that claim priority or otherwise correspond to PCT patent publication [**]. The Curis Non-Assert Patents as of the Effective Date are set forth in Exhibit C hereto.
1.19 “Curis-Originated Information” shall mean all “Proprietary Information” and “Developments,” as each such term is defined in the CQ/Curis Agreement.
1.20 “Curis Patents” shall mean Patents Controlled by Curis as of the Effective Date or during the Term that, in the absence of a license thereunder, would be infringed by the manufacture, use, sale, offer for sale or import of Compounds and/or Products in the Field in the GBMT Territory; but excluding the Curis Non-Assert Patents. The Curis Patents as of the Effective Date are set forth in Exhibit D hereto. For the avoidance of doubt, Curis Patents exclude claims of Patents Controlled by Curis to the extent such claims are directed to any pharmacologically or therapeutically active ingredient other than a Compound.
1.21 “Curis Technology” shall mean the Curis Patents and Curis Know-How.
1.22 “Curis Territory” shall mean the entire world, excluding the GBMT Territory.
1.23 “Curis Trademarks” shall mean any and all trademarks, trade names, trade dress and service marks owned or controlled by Curis or any of its Affiliates as of the Effective Date or during the Term.
1.24 “Data” shall mean any and all results of research, preclinical studies, including in vitro and in vivo studies, clinical trials and other testing of any Compound or Product conducted by or on behalf of a party either before or during the Term, and any and all other data generated by or on behalf of a party related to the development, manufacture or commercialization of any Compound or Product, including biological, chemical, pharmacological, toxicological, efficacy, pharmacokinetic, ADME, clinical, CMC, analytical, quality control, and other data, results and descriptions.
1.25 “Derivative Compound” shall mean any derivative, analogue or modification of a Compound.
1.26 “Derivative Product” shall mean any pharmaceutical product containing or incorporating a Derivative Compound, whether or not as the sole active ingredient, in any dosage form or formulation.
1.27 “Development Plan” shall have the meaning provided in Section 4.1.
1.28 “Exclusive License” shall have the meaning provided in Section 2.1.
1.29 “FDA” shall mean the United States Food and Drug Administration, or any successor agency thereto.
1.30 “Field” shall mean the treatment or prevention of any and all human diseases and disorders.
1.31 “GBMT Invention” shall mean any Invention made solely by one or more employees or contractors of GBMT.
1.32 “GBMT Know-How” shall mean all Information generated by or on behalf of GBMT during the Term relating to Compounds or Products.
1.33 “GBMT Patents” shall mean all Patents Controlled by GBMT during the Term that claim any GBMT Know-How.
1.34 “GBMT Technology” shall mean the GBMT Patents and GBMT Know-How.
1.35 “GBMT Territory” shall mean China, Macau, Taiwan and Hong Kong.
1.36 “ICH” shall mean the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
1.37 “IND” shall mean: (a) an Investigational New Drug Application filed with the FDA pursuant to 21 C.F.R. Part 312; (b) a Clinical Trial Application filed with the SFDA (or such other application as may be required to be filed with the SFDA in order to initiate a clinical trial of an investigational drug product in China); or (c) any equivalent filing with any Regulatory Authority in any other jurisdiction; in each case, including all amendments and supplements to any of the foregoing.
1.38 “Information” shall mean tangible and intangible information, techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods (including any analytical methods and other quality control and assurance methods), processes, procedures, knowledge, know-how, skill, experience, Data, results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results or descriptions, software, algorithms, compositions of matter, cells, cell lines, assays, animal models and physical, biological or chemical material.
1.39 “Initial Development Plan” shall have the meaning provided in Section 4.1.
1.40 “Invention” shall mean any discovery or invention, whether or not patentable, made in the course and as a result of the conduct of the activities expressly contemplated by this Agreement, including, without limitation, any such discovery or invention relating to the composition or formulation of any Compound or Product, and any method of making or using any Compound or Product. For the avoidance of doubt, and notwithstanding the foregoing, Inventions shall exclude “Developments,” as such term is defined in the CQ/Curis Agreement.
1.41 “Joint Invention” shall mean any Invention made jointly by one or more employees or contractors of Curis and one or more employees or contractors of GBMT.
1.42 “Joint Patents” shall mean all Patents that claim a Joint Invention.
1.43 “Joint Technology” shall mean Joint Inventions and Joint Patents.
1.44 “Joint Steering Committee” or “JSC” shall have the meaning provided in Section 3.2.
1.45 “License” shall have the meaning provided in Section 2.2.
1.46 “Manufacturing License” shall have the meaning provided in Section 2.2.
1.47 “NDA” shall mean (a) a New Drug Application filed with the FDA pursuant to 21 C.F.R. Part 314.5, et seq.; (b) a New Drug Application filed with the SFDA (or such other application as may be required to be filed with the SFDA in order to market and sell a new drug in China); or (c) the equivalent application filed with any Regulatory Authority in any other jurisdiction; in each case, including all amendments and supplements to any of the foregoing.
1.48 “Patents” shall mean patents and patent applications, including provisional applications, continuations, continuations-in-part, continued prosecution applications, divisions, substitutions, reissues, additions, renewals, reexaminations, extensions, term restorations, confirmations, registrations, revalidations, revisions, priority rights, requests for continued examination and supplementary protection certificates granted in relation thereto, as well as utility models, innovation patents, xxxxx patents, patents of addition, inventor’s certificates, and equivalents in any country or jurisdiction.
1.49 “Product” shall mean any pharmaceutical product containing or incorporating a Compound, whether or not as the sole active ingredient, in any dosage form or formulation.
1.50 “Regulatory Approval” shall mean any and all approvals (including price and reimbursement approvals, if required), licenses, registrations, or authorizations of any Regulatory Authority that are necessary to market and sell a Product in any country or other jurisdiction.
1.51 “Regulatory Authority” shall mean any country, federal, supranational, state or local regulatory agency, department, bureau or other governmental or regulatory authority having the administrative authority to regulate the development or marketing of pharmaceutical products in any country or other jurisdiction (e.g., the FDA and the SFDA).
1.52 “SFDA” shall mean the State Food and Drug Administration of China, or any successor agency thereto.
1.53 “Sublicensee” shall mean any Third Party or Affiliate of GBMT to whom GBMT (or an Affiliate of GBMT) has directly or indirectly granted a sublicense under all or any portion of the License.
1.54 “Term” shall have the meaning provided in Section 9.1.
1.55 “Third Party” shall mean any entity other than parties and their respective Affiliates.
1.56 “U.S. IND Package” shall have the meaning provided in Section 4.2(c).
1.57 “Valid Claim” shall mean a claim contained in (a) an issued and unexpired patent which has not been held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through abandonment, reissue, disclaimer or otherwise or (b) a patent application that has not been irretrievably cancelled, withdrawn or abandoned.
2. | LICENSE GRANTS. |
(a) Until delivery to Curis of the U.S. IND Package for CUDC-908, Curis’ prior written consent will be required for the grant by GBMT of any Sublicense to any Third Party or Affiliate of GBMT; provided, however, that this Section 2.4(a) shall not be construed as prohibiting GBMT from subcontracting Development Plan activities to qualified Third Party service providers as expressly permitted by Section 4.4;
(b) From and after delivery to Curis of the U.S. IND Package for CUDC-908, Curis shall have the exclusive right of first negotiation with respect to any proposed Sublicense (a “ROFN”), as described below in this Section 2.4(b). If GBMT proposes to grant any Sublicense to any Third Party or Affiliate, then, prior to offering any Sublicense to, initiating any Sublicense discussions with, or providing any Compound data to, any Third Party or Affiliate, GBMT shall deliver written notice to Curis of GBMT’s intent to grant such Sublicense, which notice shall describe the scope of the proposed Sublicense, and shall provide to Curis the complete data package regarding the applicable Compound(s) that GBMT would provide to potential Sublicensees. Curis may exercise its ROFN with respect to such proposed Sublicense by delivering written notice [**] (the “Notice Period”). If Curis exercises its ROFN for a particular proposed Sublicense, [**], the “Negotiation Period”), Curis and GBMT shall negotiate in good faith a definitive agreement under which GBMT would grant such Sublicense to Curis. During the Notice Period for a proposed Sublicense and, if Curis exercises its ROFN for such proposed Sublicense, during the applicable Negotiation Period (collectively, the “Exclusive Period”), GBMT shall not offer or grant such proposed Sublicense to any Third Party or Affiliate, nor engage in any discussions or negotiations with any Third Party or Affiliate regarding such proposed Sublicense. If [**], then GBMT shall have the right to offer and grant to a Third Party or an Affiliate of GBMT a Sublicense of no greater scope than described in GBMT’s notice to Curis; provided, however, [**]. For clarity, neither Curis’ failure to exercise its ROFN with respect to a particular proposed Sublicense, nor the parties’ failure to enter into a definitive agreement with respect to a particular proposed Sublicense, shall constitute a waiver of Curis’ ROFN with respect to any other proposed Sublicense that is of a greater scope than, or is outside of the scope of, such proposed Sublicense.
(c) Any and all sublicenses granted under the License shall be subject to, and consistent with, the terms and conditions of this Agreement.
(d) GBMT shall be fully responsible for the compliance of its Affiliates and Sublicensees with the terms and conditions of this Agreement.
2.6 Retained Rights. Curis hereby expressly reserves:
(a) the exclusive right to practice, and to grant licenses under, the Curis Technology for any and all purposes other than the development, manufacture, use, marketing, sale, offer for sale, and import of Compounds and Products in the Field in the GBMT Territory;
(b) the non-exclusive right to practice, and to grant licenses to its Affiliates and to Third Parties under, the Curis Technology and Curis’ interest in the Joint Technology, to make and have made Compounds and Products in the GBMT Territory and import such Compounds and/or Products into the Curis Territory, in each case, for the sole purpose of the development, manufacture, use, marketing, sale, offer for sale, and import of such Compounds and/or Products in the Curis Territory; and
(c) all rights in Curis Trademarks. No right or license, express or implied, is granted to GBMT to use any Curis Trademark.
3. | GOVERNANCE. |
[**] contact with each other thereafter, and shall be responsible for facilitating communications between the parties (including coordinating the transfer of Data and Information as required under this Agreement). In addition, GBMT’s Alliance Manager shall work closely with Curis’ Alliance Manager to ensure that Development Plan activities are designed and conducted such that the results of such activities are suitable for submission to the FDA in support of INDs, NDAs and Regulatory Approvals for Products, including, as applicable, cGLP, cGCP and/or cGMP.
3.3 JSC Functions and Powers. The responsibilities of the JSC shall be:
(a) to review, discuss and approve the Development Plan and amendments thereto, including, but not limited to, the CUDC-908 IND-Enabling Activities and the budget therefor;
(b) to facilitate the exchange of Curis Know-How and GBMT Know-How;
(c) to serve as a forum for GBMT to keep Curis reasonably informed regarding GBMT’s development, registration and commercialization plans, efforts and results with respect to Compounds and Products in the Field in the GBMT Territory;
(d) to seek harmonization in the parties’ respective development and Regulatory Approval efforts with respect to Compounds and Products in the Field; and
(e) to carry out such other obligations as are expressly delegated to it under this Agreement.
Field in the GBMT Territory (other than manufacturing of Compounds or Products by or on behalf of Curis for import into the Curis Territory as permitted by this Agreement), Xx. Xxxx shall have final decision-making authority; provided, however, that Xx. Xxxx, in the exercise of his final decision-making authority: (a) shall give good faith consideration to, and take into account, Curis’ position; and (b) shall not have any power (i) to modify or amend the terms and conditions of this Agreement; or (ii) to determine any issue in a manner that would conflict with the terms and conditions of this Agreement; and provided, further, that the Development Plan and any amendment thereto, including, without limitation, the CUDC-908 IND-Enabling Activities and the budget for such activities, shall not be subject to Xx. Xxxx’x final decision-making authority.
4. | DEVELOPMENT AND COMMERCIALIZATION. |
(a) conduct, or have a reputable and qualified Third Party service provider conduct on GBMT’s behalf, preclinical research and development activities with respect to CUDC-908 (or, if preclinical research and development of CUDC-908 is terminated, then, at Curis’ option, with respect to CUDC-906) in the Field in the GBMT Territory, including IND-enabling toxicology studies, all of which shall be conducted in accordance with cGLP and cGMP, such that the resulting data are suitable for submission to both the FDA and the SFDA in support of an IND filing (collectively, “CUDC-908 IND-Enabling Activities”). Any Third Party service provider proposed to be used shall be subject to Curis’ prior written approval, which shall not be unreasonably withheld;
(b) use Commercially Reasonable Efforts to complete the CUDC-908 IND-Enabling Activities [**];
(c) [**] CUDC-908 IND-Enabling Activities, deliver to Curis a data package that contains all data and other information necessary to support a U.S. IND filing for CUDC-908 by Curis (the “U.S. IND Package”). GBMT acknowledges that failure to deliver the U.S. IND Package in accordance with this Agreement shall constitute a material breach of this Agreement by GBMT;
(d) make all regulatory submissions to, and conduct all communications with, the SFDA and other Regulatory Authorities in the GBMT Territory with respect to Compounds Products in the Field;
(e) conduct clinical development of Products in the Field in the GBMT Territory, and use a reputable, qualified and independent data safety monitoring board (“DSMB”) to oversee and monitor all such clinical development activities. Any DSMB proposed to be used shall be subject to Curis’ prior written approval, which shall not be unreasonably withheld; and
(f) conduct Product manufacturing process development and scale-up and manufacture of clinical material.
Subject to the terms and conditions of this Agreement, GBMT shall have final decision-making authority regarding the development of, and the content, preparation and filing of all INDs, applications for Regulatory Approval, and other regulatory submissions with respect to, Compounds and Products, in each case, in the Field in the GBMT Territory; provided, however, that GBMT shall:
(i) [**], through its Alliance Manager, discuss GBMT’s proposed clinical strategies with Curis’ Alliance Manager;
(ii) provide Curis’ Alliance Manager with drafts of all protocols for preclinical studies and clinical trials of Compound or Product of which GBMT or its Affiliate or Sublicensee will be the sponsor and allow Curis’ Alliance Manager [**] on such drafts;
(iii) provide Curis’ Alliance Manager with the proposed labeling for any Product [**] for such Product with the SFDA; and
(iv) accept and incorporate all reasonable comments and suggestions of Curis’ Alliance Manager with respect to the matters described in the preceding subsections (i), (ii) and (iii).
4.5 Technology Transfer; Exchange of Information.
(a) Commencing promptly after the Effective Date, Curis shall disclose to GBMT all existing and available (in recorded form) Curis Know-How as reasonably required for the development, manufacture or commercialization of Product in the GBMT Territory. Thereafter, on an ongoing basis, Curis shall also disclose to GBMT any and all additional Curis Know-How generated after the Effective Date. Without limiting the generality of the foregoing, Curis shall provide to GBMT true and complete copies of all written, graphic or electronic embodiments of Data within the Curis Know-How, including all draft and final reports of any preclinical study or clinical trial of, and all CMC, pharmacology, toxicology and pharmacokinetic data with respect to, Compounds and Products, and shall promptly disclose to GBMT in writing each Curis Invention that is within the Curis Know-How and each Joint Invention.
(b) On an ongoing basis during the Term, GBMT shall disclose to Curis all GBMT Know-How necessary or useful for the development, manufacture or commercialization of Product in the Curis Territory. Without limiting the generality of the foregoing, GBMT shall provide to Curis true and complete copies of all written, graphic or electronic embodiments of Data within the GBMT Know-How, including all draft and final reports of any preclinical study or clinical trial of, and all CMC, pharmacology, toxicology and pharmacokinetic data with respect to, Compounds and Products, and shall promptly disclose to Curis in writing each GBMT Invention and Joint Invention. With respect to any of the foregoing that is in a language other than English, GBMT shall also provide Curis with an English translation thereof.
(a) Regulatory Responsibility in the GBMT Territory. GBMT shall be solely responsible for preparing and filing all INDs and NDAs in the GBMT Territory and obtaining and maintaining all Regulatory Approvals for Compounds and Products in the Field in the GBMT Territory. GBMT shall be the holder of all Regulatory Approvals for Compounds and Products in the Field in the GBMT Territory and shall have responsibility for all interactions with Regulatory Authorities with respect to Compounds and Products in the Field in the GBMT Territory. GBMT shall bear all costs and expenses incurred in connection with regulatory activities with respect to Compounds and Product in the Field in the GBMT Territory.
(b) Access to Regulatory Filings.
(i) Curis Filings. Curis shall in a timely manner provide to GBMT true and complete copies of: (A) all INDs, NDAs and Regulatory Approvals for any Compound or Product in the U.S.; and (B) other major correspondence with the FDA regarding any Compound or Product. Curis hereby grants to GBMT the right to access and cross-reference all U.S. INDs, NDAs and Regulatory Approvals for any Compound or Product for the purposes of obtaining and maintaining Regulatory Approvals for such Compound or Product in the GBMT Territory and complying with applicable adverse event reporting and other regulatory requirements in the GBMT Territory. Curis shall, promptly upon GBMT’s request, file with the FDA such letters of access or cross-reference as may be necessary to accomplish the intent of the preceding sentence.
(ii) GBMT Filings. GBMT shall in a timely manner provide to Curis:
(1) drafts of all proposed IND and NDA filings for each Product in China for review and comment reasonably in advance of submission to the SFDA or any other Regulatory Authority in China, together with English translations of any such draft INDs and NDAs that are not in English;
(2) true and complete copies of: (A) all INDs, NDAs and Regulatory Approvals for any Compound or Product in China, together with English translations of any of the foregoing that are not in English; and (B) other major correspondence with the SFDA and other Regulatory Authorities in China regarding any Compound or Product, together with English summary translations of any such correspondence that is not in English; and
(3) upon Curis’ request, true and complete copies of other INDs, NDAs and Regulatory Approvals for any Compound or Product in the GBMT Territory, and such other filings, submissions and correspondence with Regulatory Authorities in the GBMT Territory regarding any Compound or Product, as, in each case, Xxxxx xxxxx necessary or useful to obtain or maintain Approvals for any Compound or Product in the Curis Territory or to comply with applicable adverse event reporting and other regulatory requirements in the Curis Territory, together with English summary translations of any of the foregoing that are not in English.
GBMT hereby grants to Curis the right to access and cross-reference all INDs, NDAs and Regulatory Approvals for any Compound or Product in the GBMT Territory for the purposes of obtaining and maintaining Regulatory Approvals for such Compound or Product in the Curis Territory and complying with applicable adverse event reporting and other regulatory requirements in the Curis Territory. GBMT shall, promptly upon Curis’ request, file with the SFDA and other Regulatory Authorities in the GBMT Territory such letters of access or cross-reference as may be necessary to accomplish the intent of the preceding sentence.
from GBMT to Curis pursuant to this Section 4.6(c) shall be delivered to the attention of Chief Medical Officer, Curis, with a copy to Chief Executive Officer, Curis, at the address set forth in Section 12.9. Reports from Curis to GBMT pursuant to this Section 4.6(c) shall be delivered to the attention of Xx. Xxxx, at the address set forth in Section 12.9. The parties shall mutually cooperate with regard to investigation of any such serious adverse event, whether experienced by GBMT, Curis or any Affiliate, sublicensee, co-marketer or distributor of Curis or GBMT.
4.7 Commercialization. GBMT shall be solely responsible for marketing, promotion, distribution and commercialization of Products in the Field in the GBMT Territory, at GBMT’s sole expense. In marketing, promoting, distributing and commercializing Products in the Field in the GBMT Territory, GBMT shall comply with all applicable laws, rules and regulations.
5. | PAYMENTS. |
5.1 Financial Support for CUDC-908 IND-Enabling Activities. The parties acknowledge that this Agreement requires GBMT to conduct or have conducted all CUDC-908 IND-Enabling Activities in accordance with U.S. regulatory requirements such that the resulting Data is suitable for filing with the FDA of an IND for CUDC-908 (or CUDC-906, as applicable), as well as all applicable regulatory requirements in China as necessary for the filing with the SFDA of an IND for such Compound. In order to [**], Curis shall provide to GBMT up to an aggregate of U.S. $400,000, [**] CUDC-908 IND-Enabling Activities. Curis shall pay such amount to GBMT in installments on the following schedule, subject to fulfillment of the conditions specified below:
(a) U.S. $[**] within 10 business days after the cGMP synthesis and delivery to GBMT of a quantity (to be specified in the Development Plan) of CUDC-908 that meets QA/QC requirements, standards and criteria to be set forth in the Development Plan, such that it is suitable for use in (i) the cGLP IND-enabling toxicology studies that are part of the CUDC-908 IND-Enabling Activities under the Development Plan, and (ii) eventual clinical formulation;
(b) U.S. $[**] within 10 business days after completion and delivery to Curis of a certified English-language translation of the final reports from the cGLP IND-enabling toxicology studies that are part of the CUDC-908 IND-Enabling Activities under the Development Plan, which have been conducted in accordance with Sections 4.2 and 4.3, such that the results thereof are sufficient for filing with the FDA; and
(c) U.S. $[**] within 10 business days after delivery to Curis of the U.S. IND Package and Curis’ acceptance thereof in accordance with acceptance criteria to be set forth in the Development Plan.
In no event shall the aggregate amount payable by Curis under this Section 5.1 exceed U.S. $400,000.
6. | INTELLECTUAL PROPERTY. |
suggestions of, GBMT with respect to strategies for filing and prosecuting Curis Patents in the GBMT Territory. In the event that Curis seeks to abandon or cease prosecution or maintenance of any Curis Patent in the GBMT Territory, Curis shall provide reasonable prior written notice to GBMT of such intention to abandon or cease prosecution or maintenance (which notice shall be given no later than 30 days prior to the next deadline for any action that must be taken with respect to any such Curis Patent in the relevant patent office). In such case, at GBMT’s sole discretion, upon written notice to Curis from GBMT, GBMT may elect to continue prosecution and/or maintenance of any such Curis Patent, at its sole cost and expense and by counsel of its own choice.
(i) Curis shall have the sole right to bring and control any action or proceeding with respect to infringement of any Curis Patent: (A) in the Curis Territory; and (B) in the GBMT Territory with respect to any infringing activity that (1) is outside the Field, or (2) relates to any compound or product that is not a Compound or Product (whether or not it also relates to Compound or Product); in each case, at its own expense and by counsel of its own choice.
(ii) GBMT shall have the first right to bring and control any action or proceeding against a Third Party with respect to infringement of any Curis Patent in the Field in the GBMT Territory, where such infringement relates solely to Compound or Product, at its own expense and by counsel of its own choice, and Curis shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. If GBMT fails to bring any such action or proceeding within (A) [**] following the notice of alleged infringement, or (B) [**] the time limit, if any, set forth in the appropriate laws and regulations for the filing of such actions, whichever comes first, then Curis shall have the right to bring and control any such action, at its own expense and by counsel of its own choice, and GBMT shall have the right, at its own expense, to be represented in any such action by counsel of its own choice.
(i) Curis shall have the first right to bring and control any action or proceeding against a Third Party with respect to infringement of any GBMT Patent in the Field in the Curis Territory, at its own expense and by counsel of its own choice, and GBMT shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. If Curis fails to bring any such action or proceeding within (A) [**] following the notice of
alleged infringement, or (B) [**] the time limit, if any, set forth in the appropriate laws and regulations for the filing of such actions, whichever comes first, then GBMT shall have the right to bring and control any such action, at its own expense and by counsel of its own choice, and Curis shall have the right, at its own expense, to be represented in any such action by counsel of its own choice.
(ii) GBMT shall have the sole right to bring and control any action or proceeding with respect to infringement of any GBMT Patent in the GBMT Territory, at its own expense and by counsel of its own choice.
(i) Curis shall have the sole right to bring and control any action or proceeding with respect to infringement of any Joint Patent in the Curis Territory, at its own expense and by counsel of its own choice.
(ii) GBMT shall have the first right to bring and control any action or proceeding against a Third Party with respect to infringement of any Joint Patent in the GBMT Territory, at its own expense and by counsel of its own choice, and Curis shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. If GBMT fails to bring any such action or proceeding within (A) [**] following the notice of alleged infringement, or (B) [**] the time limit, if any, set forth in the appropriate laws and regulations for the filing of such actions, whichever comes first, then Curis shall have the right to bring and control any such action, at its own expense and by counsel of its own choice, and GBMT shall have the right, at its own expense, to be represented in any such action by counsel of its own choice.
any such claim involving alleged infringement of Third Party rights by GBMT’s activities at its own expense and by counsel of its own choice, and Curis shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. Neither party shall have the right to settle any patent infringement litigation under this Section 6.5 in a manner that admits the invalidity or unenforceability of the other party’s Patents or imposes any restriction or obligation on the other party, without the written consent of such other party, which shall not be unreasonably withheld.
7. | REPRESENTATIONS AND WARRANTIES. |
7.3 GBMT Acknowledgment. GBMT acknowledges [**]. GBMT further acknowledges that, [**]. In addition, GBMT acknowledges that, notwithstanding the use in this Agreement of the prefix “CUDC-” in referring to the Compounds, neither CUDC-906 nor CUDC-908 has been formally designated by Curis as a development candidate.
8. | CONFIDENTIALITY. |
(a) filing or prosecuting Patents as permitted by this Agreement;
(b) establishing or enforcing the Receiving Party’s rights under this Agreement;
(c) prosecuting or defending litigation as permitted by this Agreement;
(d) complying with a valid order of a court or other governmental body having jurisdiction or with applicable laws, rules and regulations; provided that the Receiving Party shall, except where impracticable, give reasonable advance notice to the Disclosing Party of the required disclosure, and, at the Disclosing Party’s request and expense, cooperate with the Disclosing Party’s efforts to contest such required disclosure, to obtain a protective order preventing or limiting the disclosure or requiring that the Confidential Information so disclosed be used only for the purposes for which such disclosure is required, or to obtain other confidential treatment of the Confidential Information required to be disclosed. In any event, the Receiving Party shall disclose only such Confidential Information as it is required by such order or applicable law, rule or regulation to disclose and shall only disclose such Confidential Information for the purpose and to the entity(ies) required by such order or applicable law, rule or regulation;
(e) disclosure to Third Parties in connection with due diligence or similar investigations by such Third Parties, and disclosure to potential Third Party investors in confidential financing documents, provided, in each case, that any such Third Party agrees to be bound by reasonable obligations of confidentiality and non-use; and
(f) in the case of GBMT, disclosure to bona fide potential Sublicensees, provided that each such potential Sublicensee undertakes in writing obligations of confidentiality and non-use regarding Confidential Information of Curis which are at least as stringent as those undertaken by GBMT under this Article 8.
(a) Each party agrees not to disclose to any Third Party the terms of this Agreement without the prior written consent of the other party hereto, except that each party may disclose the terms of this Agreement to the extent such disclosure is permitted under Section 8.3, Section 8.4(b), or Section 8.4(c).
(b) The parties shall coordinate in advance with each other in connection with the filing of this Agreement (including redaction of certain provisions of this Agreement) with the U.S. Securities and Exchange Commission (“SEC”) or any stock exchange on which securities issued by a party or its Affiliate are traded, and each party shall use reasonable efforts to seek confidential treatment for the terms proposed to be redacted; provided that each party shall ultimately retain control over what information to disclose to the SEC or any stock exchange, as the case may be, and provided further that the parties shall use their reasonable efforts to file redacted versions which are consistent with redacted versions previously filed with the SEC or any stock exchange.
(c) The parties acknowledge that either party may be required to file a copy of certain terms of this Agreement with government authorities in the GBMT Territory or in the Curis Territory for registration or approval purposes. Each party shall notify the other in writing of any such required filing, in which event, the parties agree to execute for such purpose a tailored short-form agreement (comprising relevant portions of this Agreement) mutually acceptable to the parties which incorporates only those provisions that need to be disclosed to the relevant government authority. The party required to make such filing shall file only such tailored short-form agreement with the relevant government authority.
9. | TERM AND TERMINATION. |
9.2 Termination for Material Breach.
(a) A party may terminate this Agreement for material breach of this Agreement by the other party upon 60 days’ written notice specifying the nature of the breach, unless the breaching party cures such breach within such 60-day period.
(b) Curis shall have the right to terminate this Agreement immediately upon written notice to GBMT, if GBMT, its Affiliate or Sublicensee directly, or through assistance granted to a Third Party, commences any interference or opposition proceeding with respect to, or challenges the validity or enforceability of, any Curis Patent or Curis Non-Assert Patent.
9.5 Consequences of Expiration or Termination.
(a) Upon expiration (but not earlier termination) of this Agreement pursuant to Section 9.1, the License granted to GBMT shall survive on a non-exclusive, irrevocable, perpetual basis.
(b) Upon any termination of this Agreement prior to its expiration, the License shall automatically terminate and revert to Curis.
(c) [**] the termination of this Agreement for any reason prior to its expiration, GBMT shall: (i) return to Curis all Confidential Information of Curis and all Curis Technology that is in GBMT’s or its Affiliates’ possession, including any and all documentation and other tangible embodiments thereof, except that GBMT may retain one archival copy of Curis’ Confidential Information solely for purposes of monitoring compliance with its obligations hereunder and complying with applicable law; (ii) transfer to Curis all data and information in the possession of GBMT or its Affiliates relating to Compounds or Products (to the extent not previously disclosed to Curis); (iii) to the maximum extent permitted by applicable law, transfer and assign to Curis or its designee all of its right, title and interest in and to all INDs, Regulatory Approvals (including applications therefor), drug dossiers and master files with respect to any Compound or Product in the GBMT Territory, including any and all documentation relating thereto; and (iv) take such other actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights to Curis under this Section 9.5(c).
(d) Neither expiration nor termination shall relieve either party of any obligation accruing prior to such expiration or termination. Except as expressly set forth elsewhere in this Agreement, the obligations and rights of the parties under Sections 2.8, 4.6(b)(ii), 4.6(c), 6.1, 6.2(b), 6.2(c), 6.3, 6.4(a), 6.4(c), 6.4(d), 6.4(e), 6.4(f), 7.3, 7.4, 7.5, 8.1, 8.2, 8.3, 8.4, 9.5, 9.6 and 9.7 and Articles 10, 11 and 12 shall survive termination or expiration of this Agreement.
to be performed by such party. If a case is commenced during the Term by or against a party under the Bankruptcy Laws, this Agreement is rejected as provided in the Bankruptcy Laws and the other party elects to retain its rights hereunder as provided in the Bankruptcy Laws, then the party subject to such case under the Bankruptcy Laws (in any capacity, including debtor-in-possession) and its successors and assigns (including a Title 11 trustee), shall provide to the other party copies of all Information necessary for such other party to prosecute, maintain and enjoy its rights under the terms of this Agreement promptly upon such other party’s written request therefor. All rights, powers and remedies of the non-bankrupt party as provided herein are in addition to and not in substitution for any and all other rights, powers and remedies now or hereafter existing at law or in equity (including, without limitation, the Bankruptcy Laws) in the event of the commencement of a case by or against a party under the Bankruptcy Laws.
10. | INDEMNIFICATION. |
indemnification obligation under this Agreement except and only to the extent that such Indemnifying Party is actually damaged as a result of such failure to give notice), shall permit the Indemnifying Party to assume direction and control of the defense of the claim (including the right to settle the claim solely for monetary consideration), and shall cooperate as requested (at the expense of the Indemnifying Party) in the defense of the claim. The Indemnified Party shall not agree to any settlement of such action, suit, proceeding or claim without the prior written consent of the Indemnifying Party. The Indemnifying Party shall not agree to any settlement of such action, suit, proceeding or claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Indemnified Party from all liability with respect thereto, that imposes any liability or obligation on the Indemnified Party or that acknowledges fault by the Indemnified Party; in each case, without the prior written consent of the Indemnified Party.
11. | DISPUTE RESOLUTION. |
(a) Subject to Section 11.4 below, any dispute, controversy or claim that is not resolved pursuant to Section 11.1 shall be resolved by final and binding arbitration in accordance with the applicable rules of the London Court of International Arbitration (“LCIA”) as then in effect (the “Rules”), except to the extent any such Rule conflicts with the express provisions of this Article 11.
(b) The arbitration shall be conducted by an arbitral tribunal of three neutral arbitrators selected by the LCIA Court in accordance with the Rules; provided that such arbitrators shall not be current or former employees or directors, or current stockholders, of either party, any of their respective Affiliates or any Sublicensee; and provided, further, that each arbitrators shall have experience and familiarity with commercial licensing practices in the pharmaceutical and biotechnology industries. The place of arbitration shall be Boston, Massachusetts, USA, and all proceedings and communications shall be in English.
(c) The arbitral tribunal shall permit discovery (including both the production of documents and deposition testimony) as reasonably necessary for an understanding of any legitimate issue raised in the arbitration, while also taking into account the desirability of making discovery efficient and cost-effective.
(d) The arbitral tribunal shall, in rendering an award, apply the substantive law of the Commonwealth of Massachusetts, USA, without giving effect to its principles of conflicts of law, and without giving effect to any of its rules or laws relating to arbitration. The award shall include a written statement describing the essential findings and conclusions upon which the award is based, including the calculation of any damages awarded. The arbitral tribunal’s authority to award special, incidental, consequential or punitive damages shall be subject to the limitation set forth in Section 7.5, except to the extent the substantive laws of the Commonwealth of Massachusetts, USA, do not permit such limitation. The award rendered by the arbitral tribunal shall be final, binding and non-appealable (subject only to the parties’ right to request correction of any errors in computation, clerical or typographical errors, or other errors of a similar nature, and the arbitral tribunal’s right to make any such correction on its own initiative, in each case, in accordance with the Rules), and judgment upon the award may be entered in any court of competent jurisdiction.
(e) Each party shall bear its own attorneys’ fees, costs, and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the arbitration; provided, however, that the arbitral tribunal shall be authorized to determine whether a party is the prevailing party, and if so, to award to that prevailing party reimbursement for any or all of its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel expenses, etc.), and/or the fees and costs of the LCIA Court and the arbitral tribunal.
12. | MISCELLANEOUS. |
12.2 Governing Law. This Agreement shall be governed by, and construed and enforced in accordance with, the laws of the Commonwealth of Massachusetts, USA, excluding its conflicts of laws principles.
(a) in connection with the transfer or sale of all or substantially all of Curis’ business to which this Agreement relates to a Third Party, whether by merger, sale of stock, sale of assets or otherwise, provided that in the event of such a sale or transfer (whether this Agreement is actually assigned or is assumed by the acquiring party by operation of law (e.g., in the context of a reverse triangular merger)), intellectual property rights of the acquiring party in such sale or transfer (if other than Curis) shall not be included in the technology licensed hereunder or otherwise subject to this Agreement; or
(b) to an Affiliate of Curis, provided that Curis shall remain liable and responsible to GBMT for the performance and observance of all such duties and obligations by such Affiliate.
The rights and obligations of the parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the parties, and the name of a party appearing herein will be deemed to include the name of such party’s successors and permitted assigns to the extent necessary to carry out the intent of this section. Any assignment not in accordance with this Agreement shall be void.
If to Curis: | Curis, Inc. 0 Xxxxxxx Xxxx Xxxxxxxxx, XX 00000 XXX Attention: Chief Executive Officer Telephone: x0 (000) 000-0000 Facsimile: x0 (000) 000-0000 | |
With a copy to: | Curis, Inc. 0 Xxxxxxx Xxxx Xxxxxxxxx, XX 00000 XXX Attention: Chief Medical Officer Telephone: x0 (000) 000-0000 Facsimile: x0 (000) 000-0000 |
If to GBMT: | Guangzhou BeBetter Medicine Technology LTD Co. Room C209, Sector C Guangzhou International Business Incubator 3 Juquan Road, Guangzhou Science Park Guangdong 510663 People’s Republic of China Attention: Changgeng Qian, Ph.D., M.D. Telephone: x00-00-0000-0000 Facsimile: x00-00-0000-0000 | |
and: | Xx. Xxxxxxxxx Xxxx [**] USA Telephone: [**] |
[Signature page follows]
IN WITNESS WHEREOF, the parties hereto have duly executed this Drug Development Partnership and License Agreement as of the Effective Date.
CURIS, INC. | GUANGZHOU BEBETTER MEDICINE TECHNOLOGY LTD CO. | |||||||
By: | /s/ Xxxxxx X. Xxxxxxx | By: | /s/ Changgeng Qian | |||||
Name: | Xxxxxx X. Xxxxxxx | Name: | Changgeng Qian | |||||
Title: | President and CEO | Title: | Legal Representative |
Exhibit A
CUDC-906
[**]
Compound Name: CUDC-906
Curis registration Number: [**]
Chemical Name: [**]
Exhibit B
CUDC-908
[**]
Compound Name: CUDC-908
Curis registration Number: [**]
Chemical Name: [**]
Exhibit C
CURIS NON-ASSERT PATENTS
Country of Filing | Application Serial Number | Publication Number | ||
[**] | [**] | [**] | ||
[**] | [**] | [**] | ||
[**] | [**] | [**] | ||
[**] | [**] | [**] |
Exhibit D
CURIS PATENTS
Country of Filing | Application Serial Number | Publication Number | ||
[**] | [**] | [**] | ||
[**] | [**] | |||
[**] | [**] | [**] | ||
[**] | [**] | [**] |
Exhibit E
INITIAL DEVELOPMENT PLAN
Dual HDAC and PI3K Inhibitor CUDC-908/CUDC-906
Clinical Development Plan
(Preliminary)
Contents
Summary
Rationale for Dual Pi3K/HDAC Inhibitors
Pharmacological Properties of CUDC-908 and CUDC-906
Comparison of CUDC-906, [**] and CUDC-908
In Vitro Potency and Mechanism of Action
[**]
Efficacy Studies
Safety Assessment
Overall Strategy of CUDC-908 and CUDC-906 Clinical Development
CUDC-908 IND-Enabling Studies and IND-Filing
CMC and Clinical Formulation
GLP Toxicity and TK Studies
CUDC-908 Clinical Trial Plan
Indications
[**]
Clinical Development Plan
Clinical Development Objectives
Phase I Study
Phase II Study
Collaboration and Timelines
Finance
Reference
Summary
[**].
Rationale for Dual Pi3K/HDAC Inhibitors
[**].
Pharmacological Properties of CU-908 and CU-906
Comparison of [**], CU-908, and CU-906,
[**].
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In Vitro Potency and Mechanism of Action
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[**]. A total of two pages were omitted and filed separately with the Securities and Exchange Commission.
Efficacy Studies
[**]. A total of three pages were omitted and filed separately with the Securities and Exchange Commission.
Safety Assessment
[**].
Overall Strategy of CUDC-908 and CUDC-906 Clinical Development
[**].
CU-908 IND-Enabling Studies and IND-Filing
CMC and Clinical Formulation
[**]:
A total of two pages were omitted and filed separately with the Securities and Exchange Commission.
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CU-908 Clinical Trial Plan
Indications
[**].
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Clinical Development Plan
[**]
Phase I Study
[**].
Phase II Study
[**].
Collaboration and Timelines
After license grant to GBMT in February 2012, [**].
[**].
[**]
Finance
The estimated cost [**].
References
[**].