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Exhibit 10.4
LICENSE AND COLLABORATION AGREEMENT
THIS LICENSE AND COLLABORATION AGREEMENT (the “Agreement” ) is entered into as of November 19, 2003 (the “Effective Date” ) by and among MAXIM PHARMACEUTICALS, INC. , a Delaware corporation ( “Maxim Pharmaceuticals” ), having an address of 8899 University Center Lane, Suite 400, San Diego, California 92122, and CYTOVIA, INC. , a Delaware corporation and wholly-owned subsidiary of Maxim Pharmaceuticals ( “Cytovia” ), having an address of 8899 University Center Lane, Suite 400, San Diego, California 92122 (Maxim Pharmaceuticals and Cytovia are hereinafter collectively referred to as “Maxim” ), and MYRIAD GENETICS, INC. , a Delaware corporation, having an address of 320 Wakara Way, Salt Lake City, Utah 84108 ( “Myriad” ).
RECITALS
WHEREAS, Maxim has developed expertise and proprietary rights related to its MX90745 series of compounds, including but not limited to MX128495, as more fully described below;
WHEREAS, Myriad is engaged in the research, development and commercialization of pharmaceutical products; and
WHEREAS, Myriad and Maxim desire to enter into a collaborative relationship to identify and develop Products (as defined below) for clinical development and commercialization by Myriad, subject to the terms and conditions set forth herein.
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:
1. DEFINITIONS
1.1 “Affiliate” shall mean any company or entity controlled by, controlling, or under common control with a party hereto and shall include any company more than 50% of whose voting stock or participating profit interest is owned or controlled, directly or indirectly, by a party, and any company which owns or controls, directly or indirectly, more than 50% of the voting stock of a party.
1.2 “Calendar Quarter” shall mean each respective period of three (3) consecutive months ending on March 31, June 30, September 30 and December 31.
1.3 “Confidential Information” shall have the meaning provided in Section 10.1.
1.4 “Control” shall mean, with respect to any Information, Patents or other intellectual property rights, possession by a party of the right, power and authority (whether by ownership, license or otherwise) to grant access to, to grant use of, or to grant a license or a sublicense to such Information, Patents or intellectual property rights without violating the terms of any agreement or other arrangement with any Third Party.
1.5 “FDA” shall mean the United States Food and Drug Administration, or any successor agency thereto having the administrative authority to regulate the marketing of human pharmaceutical products or biological therapeutic products, delivery systems and devices in the United States of America.
1.6 “Field” shall mean the treatment and/or prevention of any disease or disorder.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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1.7 “First Commercial Sale” shall mean, with respect to any Product, the first sale for end use or consumption of such Product in a country after the governing health regulatory authority of such country has granted Regulatory Approval. Sale to an Affiliate or Sublicensee shall not constitute a First Commercial Sale unless the Affiliate or Sublicensee is the end user of the Product.
1.8 “FTE” shall mean the equivalent of a full-time scientist’s work time over a 12-month period (including normal vacations, sick days and holidays). The portion of an FTE year devoted by a scientist to the Research Program shall be determined by dividing the number of full working days during any 12-month period devoted by such scientist to the Research Program by the total number of working days in such 12-month period. Each party understands and agrees that the other party retains complete discretion to change the identity of any individual employee or consultant devoted to the Research Program and/or the frequency and the time during which such individual employee’s or consultant’s efforts are devoted to the Research Program, provided that in any event each such employee or consultant devoted to the Research Program shall satisfy the criteria for general experience and qualifications set forth in the Research Plan.
1.9 “IND” shall mean an Investigational New Drug Application filed with the FDA, or the equivalent application or filing filed with any equivalent agency or governmental authority outside the United States of America (including any supra-national agency such as in the European Union) necessary to commence human clinical trials in such jurisdiction.
1.10 “Information” shall mean all tangible and intangible (a) techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, know-how, skill, experience, test data and results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms and (b) compositions of matter, cells, cell lines, assays, animal models and physical, biological or chemical material.
1.11 “Inventions” shall have the meaning provided in Section 8.1.
1.12 “Joint Inventions” shall have the meaning provided in Section 8.1.
1.13 “Joint Patents” shall mean all Patents that claim or disclose a Joint Invention.
1.14 “Joint Development Committee” or “JDC” shall mean the committee formed pursuant to Section 2.1.
1.15 “Major Market” shall mean [***] .
1.16 “Maxim Inventions” shall have the meaning provided in Section 8.1.
1.17 “Maxim Know-How” shall mean, to the extent useful for purposes of the Research Program or necessary to develop, make, have made, use, distribute for sale, promote, market, offer for sale, sell, have sold, import or export any Product, Information not included in the Maxim Patents or Joint Patents that Maxim or any of its Affiliates Controls on the Effective Date or during the Term, including, without limitation, all such Information that is conceived or developed by Maxim or any of its Affiliates in the course and as part of the Research Program, and, in each case, any replication or any part of such Information.
1.18 “Maxim Patents” shall mean, to the extent useful or necessary to develop, make, have made, use, distribute for sale, promote, market, offer for sale, sell, have sold, import or export any Product, all Patents that Maxim or any of its Affiliates Controls as of the Effective Date or during the Term, but excluding the Joint Patents.
1.19 “Maxim Technology” shall mean the Maxim Patents and Maxim Know-How.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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1.20 “MX90745 Series” shall mean the series of compounds described in [***] .
1.21 “Myriad Inventions” shall have the meaning provided in Section 8.1.
1.22 “Myriad Know-How” shall mean, to the extent useful for purposes of the Research Program or necessary to develop, make, have made, use, distribute for sale, promote, market, offer for sale, sell, have sold, import or export any Product, Information not included in the Myriad Patents or Joint Patents that Myriad or any of its Affiliates Controls on the Effective Date or during the Term, including, without limitation, all such Information that is conceived or developed by Myriad or any of its Affiliates in the course and as part of the Research Program, and, in each case, any replication or any part of such Information.
1.23 “Myriad Patents” shall mean, to the extent useful for purposes of the Research Program or necessary to develop, make, have made, use, distribute for sale, promote, market, offer for sale, sell, have sold, import or export any Product, all Patents that Myriad or any of its Affiliates Controls as of the Effective Date or during the Term, but excluding the Joint Patents.
1.24 “Myriad Technology” shall mean the Myriad Patents and Myriad Know-How.
1.25 “NDA” shall mean a New Drug Application (as more fully defined in 21 C.F.R. 314.5 et seq. ) and all amendments and supplements thereto filed with the FDA, or the equivalent application filed with any equivalent agency or governmental authority outside the United States of America (including any supra-national agency such as in the European Union), including all documents, data, and other information concerning a pharmaceutical product which are necessary for gaining Regulatory Approval to market and sell such pharmaceutical product.
1.26 “Net Sales” shall mean the gross amounts invoiced by Myriad, its Affiliates and [***] its Sublicensees for sales of Products to Third Parties that are not Affiliates or Sublicensees of the selling party (unless such Affiliate or Sublicensee is the end user of such Product, in which case the amount billed therefor shall be deemed to be the amount that would be billed to a Third Party end user in an arm’s-length transaction), less the following items, as allocable to such Product (if not previously deducted from the amount invoiced): (i) trade discounts, credits or allowances; (ii) credits or allowances additionally granted upon returns, rejections or recalls (except where any such recall arises out of Myriad’s, its Affiliate’s or Sublicensee’s gross negligence, willful misconduct or fraud); (iii) freight, shipping and insurance charges; (iv) taxes, duties or other governmental tariffs (other than income taxes); (v) government mandated rebates; and (vi) all such invoiced amounts that are written off as bad debt by Myriad, its Affiliates or U.S. Sublicensees (with such bad debt adjustment to be reduced by invoiced amounts that collected in the current period that were written off in prior periods).
1.27 “Patents” shall mean (a) United States patents, re-examinations, reissues, renewals, extensions and term restorations, and foreign counterparts thereof, and (b) pending applications for United States patents, including, without limitation, provisional applications, continuations, continuations-in-part, divisional and substitute applications, including, without limitation, inventors’ certificates, and foreign counterparts thereof.
1.28 “Percentage-Based Payments” shall have the meaning provided in Section 6.6.
1.29 “Phase 1 Clinical Trial” shall mean a human clinical trial that would satisfy the requirements for a Phase 1 study as defined in 21 C.F.R. 312.21(a) (or its successor regulation).
1.30 “Phase 2 Clinical Trial” shall mean a human clinical trial that would satisfy the requirements for a Phase 2 study as defined in 21 C.F.R. 312.21(b) (or its successor regulation).
1.31 “Phase 3 Clinical Trials” shall mean a human clinical trial that would satisfy the requirements for a Phase 3 study as defined in 21 C.F.R. 312.21(c) (or its successor regulation).
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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1.32 “Product” shall mean a product that contains any composition of matter in the MX90745 Series, or any analog, homolog, derivative or isomer of any composition of matter in the MX90745 Series, including, in each case, all formulations, line extensions and modes of administration thereof. Product shall also mean any product developed in the Research Program.
1.33 “Regulatory Approval” shall mean any and all approvals (including price and reimbursement approvals, if required), licenses, registrations, or authorizations of any country, federal, supranational, state or local regulatory agency, department, bureau or other government entity that are necessary for the manufacture, use, storage, import, transport and/or sale of a Product in such jurisdiction.
1.34 “Research Plan” shall mean the plan for conducting the Research Program, as amended from time to time by the JDC. The initial Research Plan has been agreed upon by the parties in writing as of the Effective Date and is attached hereto as Exhibit A.
1.35 “Research Program” shall mean a research program carried out by Maxim during the Research Term pursuant to Articles 2 and 3 hereof, as more fully described in the Research Plan.
1.36 “Research Term” shall mean the period beginning on the Effective Date and ending on the first (1 st ) anniversary of the Effective Date, subject to extension for one (1) additional year in accordance with Section 3.4 and to termination in accordance with Article 11.
1.37 “Royalty Term” shall mean, in the case of any Product, in any country, the period of time commencing on the First Commercial Sale in such country and ending upon the later of (a) ten (10) years after the date of First Commercial Sale in such country, and (b) the expiration of the last to expire of the Maxim Patents or Joint Patents containing a Valid Claim claiming the manufacture, use or sale of such Product in such country.
1.38 “Sublicensee” shall mean a Third Party to whom Myriad or any of its Affiliates has granted a license or sublicense of the right to develop, make, have made, use, distribute for sale, promote, market, offer for sale, sell, have sold, import or export Products, beyond the mere right to purchase Product from Myriad or its Affiliates.
1.39 “Sublicensing Revenues” shall mean the amount actually received by Myriad or an Affiliate of Myriad from any and all Sublicensees arising from the license or sublicense of the right to develop, make, have made, use, distribute for sale, promote, market, offer for sale, sell, have sold, import or export Products [***] . Sublicensing Revenues shall include up-front or license fees, milestone payments, royalties paid to Myriad or any of its Affiliates by a Sublicensee based on such Sublicensee’s sale of Products, premiums above the fair market value on sales of securities, annual maintenance fees and any other payments in respect of the grant to such Sublicensee of a license or sublicense of the right to develop, make, have made, use, distribute for sale, promote, market, offer for sale, sell, have sold, import or export Products [***] (with any of the foregoing consideration received by Myriad or its Affiliate other than in the form of cash to be valued at its fair market value as of the date of receipt); provided, however, that Sublicensing Revenues shall not include any payments tied directly to the provision of goods and services by Myriad or its Affiliate to such Sublicensee (including research and development and manufacturing) to compensate Myriad or its Affiliate for the fair market value of the provision of such goods and services, reimbursement to Myriad by Maxim or a Third Party for costs or expenses incurred by Myriad in the performance of its obligations under this Agreement (including reimbursement for patent and trademark costs but excluding costs or expenses associated with the development and pursuit of Regulatory Approval for any Product), or payments for securities (other than premiums above the fair market value of such securities).
1.40 “Term” shall have the meaning provided in Section 11.1.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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1.41 “Third Party” shall mean any entity other than Maxim or Myriad or an Affiliate of Maxim or Myriad.
1.42 “Valid Claim” shall mean (a) an unexpired claim of an issued patent within the Maxim Patents or Joint Patents which has not been found to be unpatentable, invalid or unenforceable by a court or other authority in the subject country, from which decision no appeal is taken or can be taken; or (b) a claim of a pending application within the Maxim Patents or Joint Patents, which application claims a first priority no more than five (5) years prior to the date upon which pendency is determined.
2. RESEARCH PROGRAM GOVERNANCE
2.1 Joint Development Committee. Promptly after the Effective Date, the parties will form a Joint Development Committee (the “JDC” ) comprised of three (3) representatives of each of Myriad and Maxim. One (1) member of the JDC shall be selected to act as the chairperson of the JDC, with each chairperson acting for a term of twelve (12) months. The chairperson shall be selected alternately by Maxim and Myriad, and Myriad shall designate the first chairperson. The JDC shall meet at least four (4) times per year during the Research Term or at such greater frequency as the JDC agrees. Such meetings may be conducted by videoconference, teleconference or in person, as agreed by the parties, and the parties shall agree upon the time of meetings. Within 30 days after each meeting, the JDC chairperson will provide the parties with a written report describing, in reasonable detail, the status of the Research Program, a summary of the results and progress to date, the issues requiring resolution, and the agreed resolution of previously reported issues. A reasonable number of additional representatives of a party may attend meetings of the JDC in a non-voting capacity.
2.2 Joint Development Committee Functions and Powers. The responsibilities of the JDC shall be as follows:
(a) encouraging and facilitating communication between the parties with respect to the Research Program;
(b) establishing, updating, reviewing and approving the Research Plan and other plans for accomplishing the goals of the Research Program;
(c) overseeing development and regulatory strategies for Products;
(d) monitoring progress of the Research Program and Maxim’s diligence in carrying out its responsibilities thereunder; and
(e) carrying out the other duties and responsibilities described for it in this Agreement.
2.3 JDC Decision-Making. Decisions of the JDC shall be made by unanimous vote, with each party having one (1) vote. No vote of the JDC may be taken unless at least two (2) of each party’s representatives on the JDC vote. If the JDC is unable to reach a unanimous vote on any matter, then the matter shall be referred to the Chief Executive Officer of Maxim and the Chief Executive Officer of Myriad for further discussion and resolution. These individuals shall as soon as practicable attempt in good faith to resolve the matter and thereby make the decision on behalf of the JDC. These individuals may obtain the advice of other employees or consultants as they deem necessary or advisable in order to make the decision. In the event that these individuals are unable to resolve the matter within 30 days of commencing such discussions, the [***] ; provided, however, that [***] be construed to permit [***] to, and neither [***] shall have the right to: (a) [***] ; (b) [***] ; (c) [***] .
3. CONDUCT OF THE RESEARCH PROGRAM
3.1 Objectives; Responsibilities. The parties hereby agree to establish the Research Program, to be conducted by Maxim during the Research Term in accordance with the Research Plan and with the terms of this Agreement, with the goal of discovering and
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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developing one or more Products for development and commercialization by Myriad. Any amendments or revisions to the Research Plan shall be in writing and shall require unanimous approval of the JDC. Myriad shall be responsible for development and Regulatory Approval of Products, as more fully described in Article 4, and Maxim shall assist Myriad in Myriad’s development efforts through Maxim’s performance of its obligations under the Research Plan. In addition, at Myriad’s request, Maxim will contribute high-level support in the areas of clinical development and regulatory strategy to support Myriad’s development of Products.
3.2 Technology Transfer. Commencing promptly after the Effective Date and from time to time thereafter during the Research Term, Maxim shall disclose to Myriad the Maxim Technology to the extent necessary to enable Myriad to exercise fully the licenses granted to Myriad under Article 5 hereof. Commencing promptly after the Effective Date and from time to time thereafter during the Research Term, Myriad will disclose to Maxim such Myriad Technology as is reasonably necessary to enable Maxim to perform its Research Program activities hereunder in accordance with the Research Plan and otherwise to exercise fully the licenses granted to Maxim under Article 5 hereof. During the Research Term, Maxim will provide Myriad with reasonable technical assistance relating to the use of the Maxim Technology by Myriad solely to the extent permitted under the license granted to Myriad under Article 5. During the Research Term, Myriad will provide Maxim with reasonable technical assistance relating to the use of the Myriad Technology by Maxim solely to the extent permitted under the license granted to Maxim under Article 5.
3.3 Performance Standards. Maxim shall conduct its activities under the Research Program in good scientific manner, and in compliance in all material respects with the requirements of applicable laws and regulations and with applicable good laboratory practices, to attempt to achieve its objectives efficiently and expeditiously. Maxim shall maintain laboratories, offices and all other facilities reasonably necessary to carry out the activities to be performed pursuant to the Research Plan. In conformity with standard pharmaceutical and biotechnology industry practices and the terms and conditions of this Agreement, Maxim shall prepare and maintain, or shall cause to be prepared and maintained, complete and accurate written records, accounts, notes, reports and data with respect to activities conducted pursuant to the Research Plan and, upon Myriad’s written request, shall send legible copies of the aforesaid to Myriad. Upon reasonable advance notice, Maxim agrees to make its employees and non-employee consultants reasonably available at their respective places of employment to consult with Myriad on issues arising during the Term and in connection with any request from any regulatory agency, including, without limitation, regulatory, scientific, technical and clinical testing issues.
3.4 Research Commitment; Research Term Extension. During the Research Term, Maxim shall use its commercially reasonable efforts to conduct the Research Program in accordance with the Research Plan, as revised from time to time by the JDC. Without limiting the generality of the foregoing, and subject to Myriad’s compliance with its funding obligations under Section 6.2 hereof, Maxim shall devote to the Research Program [***] FTEs during the one (1) year period following the Effective Date. At Myriad’s option, exercisable by written notice to Maxim given no less than 60 days prior to the first (1 st ) anniversary of the Effective Date, Myriad may extend the Research Term until the second (2 nd ) anniversary of the Effective Date. In the event of such extension, Maxim shall devote to the Research Program up to [***] FTEs during such additional year of the Research Term, subject to Myriad’s compliance with its funding obligations under Section 6.2 hereof.
3.5 Research Reports. Maxim shall keep Myriad fully informed as to all discoveries and technical developments (including, without limitation, any Inventions) made in the course of performing activities under the Research Program. In particular, Maxim shall prepare, and distribute to all members of the JDC no later than five days prior to the next JDC meeting, a reasonably detailed written summary report, in such form and format and setting forth such information regarding the results and progress of performance of the Research Program as determined from time to time by the JDC.
3.6 Subcontracts. Maxim may perform some of its obligations under the Research Plan through one (1) or more subcontractors, provided that (a) none of the rights of either party hereunder are diminished or otherwise adversely affected as a result of such
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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subcontracting, and (b) the subcontractor undertakes in writing obligations of confidentiality and non-use regarding Confidential Information which are substantially the same as those undertaken by the parties pursuant to Article 10 hereof. In the event Maxim performs any of its obligations under the Research Plan through a subcontractor, then Maxim will at all times be responsible for the performance and payment of such subcontractor. Additionally, all such subcontractors shall be obligated to enter into a written agreement to assign all of Subcontractor’s intellectual property rights for any work performed under the Research Program to Maxim.
3.7 Materials Transfer. In order to facilitate the Research Program, either party may provide to the other party certain biological materials or chemical compounds Controlled by the supplying party, including, but not limited to, compounds from the MX90745 Series or analogs, homologs, derivatives or isomers thereof (collectively, “Materials” ) for use by the other party in furtherance of the Research Program. Except as otherwise provided under this Agreement, all such Materials delivered to the other party will remain the sole property of the supplying party, will be used only in furtherance of the Research Program in accordance with this Agreement, and will be used in compliance with all applicable laws, rules and regulations. The Materials supplied under this Agreement must be used with prudence and appropriate caution in any experimental work because not all of their characteristics may be known. Except as expressly set forth herein, THE MATERIALS ARE PROVIDED “AS IS” AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY.
4. DEVELOPMENT AND COMMERCIALIZATION OF PRODUCTS
4.1 Development and Commercialization of Products. Subject to the terms and conditions of this Agreement (including, without limitation, Section 5.2), Myriad shall control the worldwide development and commercialization of Products, including, but not limited to, the worldwide supply of Products for use in development and commercialization activities.
4.2 Disclosure Regarding Myriad Efforts. Myriad will keep Maxim appropriately informed about Myriad’s research, development, clinical trial progress and commercialization efforts with respect to Products. Without limiting the generality of the foregoing, Myriad shall provide Maxim with written notice of the following:
(a) identification or generation of any Product by or on behalf of Myriad or any of its Affiliates outside of the Research Program or after the Research Term for which IND-enabling non-clinical studies are commenced;
(b) filing of an IND or NDA with respect to any Product in any jurisdiction;
(c) initiation of Phase I Clinical Trials, Phase II Clinical Trials and Phase III Clinical Trials, and Regulatory Approval, with respect to any Product in any jurisdiction; and
(d) clinical trial progress and commercialization plans, activities and results with respect to Products in any jurisdiction.
With respect to clause (a) of this Section 4.2, Myriad shall disclose to Maxim any such Products generated by or on behalf of Myriad or any of its Affiliates during any Calendar Quarter within 30 days of the end of such Calendar Quarter. With respect to clauses (b) and (c) of this Section 4.2, Myriad will provide such notice promptly (and in any event within 10 days) following the occurrence of the applicable event. With respect to clause (d) of this Section 4.2, such notice shall be provided to Maxim as regularly as appropriate to keep Maxim reasonably informed, and, in any event, Myriad shall provide Maxim with annual written reports summarizing in reasonable detail any such events that have occurred during the applicable twelve (12) month period. The provisions of this Section 4.2 shall survive expiration or termination of the Research Term for so long as Myriad has a license hereunder pursuant to Section 11.3.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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5. LICENSES
5.1 License Grants.
(a) By Maxim.
(i) Research License. Subject to the terms and conditions of this Agreement, Maxim hereby grants to Myriad and its Affiliates, during the Term, a non-exclusive, worldwide, royalty-free license, without the right to sublicense, under the Maxim Technology solely to perform Myriad’s obligations under the Research Plan.
(ii) Development and Commercialization License. Subject to the terms and conditions of this Agreement, Maxim hereby grants to Myriad, during the Term, an exclusive (even as to Maxim), worldwide, royalty-bearing license, with the right to sublicense, under the Maxim Technology and Maxim’s interest in the Joint Patents, to develop, make, have made, use, sell, distribute for sale, offer for sale, have sold and import or export Products in the Field. Myriad will at all times be responsible for the performance of its Sublicensees and Third Party contractors under this Agreement.
(b) By Myriad. Subject to the terms and conditions of this Agreement, Myriad hereby grants to Maxim and its Affiliates, during the Research Term, a non-exclusive, worldwide, royalty-free license, without the right to sublicense, under the Myriad Technology solely to perform Maxim’s obligations under the Research Plan.
5.2 Diligence Obligations. Myriad agrees to use commercially reasonable efforts to develop and commercialize one or more Products in the Major Markets.
(a) In the event that Myriad or a Sublicensee is not conducting development or commercialization of at least one Product in a particular Major Market, then Myriad shall provide Maxim with prompt written notice thereof.
(b) In addition, if Maxim in good faith believes that Myriad is not using its commercially reasonable efforts to develop or commercialize at least one Product in a particular Major Market, Maxim may provide Myriad with written notice thereof, in which event Myriad will have 60 days from the date of such notice in which to show commercially reasonable efforts. If the parties can not agree as to what are commercially reasonable efforts, then such matter shall be resolved pursuant to the resolution procedures set forth in Section 11.3. If the arbitrators decide that the efforts undertaken by Myriad have not been commercially reasonable, Myriad shall have 60 days to have commenced and thereafter reasonably proceed forward with the completion of such efforts as determined by the arbitration panel to be commercially reasonable. If Myriad fails to implement the commercially reasonable efforts designated by the arbitration panel, then Maxim’s claim under this Section 5.2(b) shall be deemed to have been resolved against Myriad.
5.3 Maxim [***] Rights. If Myriad provides Maxim with notice under Section 5.2(a) above, or if Maxim provides Myriad with notice under Section 5.2(b) above (provided, in the event of a dispute, that the matter under Section 5.2(b) is ultimately resolved against Myriad), then:
(a) the license granted to Myriad under Section 5.1(a)(ii) [***] ;
(b) Myriad shall [***] ; and
(c) Maxim shall have [***] . Maxim shall have [***] , to notify Myriad in writing either that (i) [***] or (ii) [***] . If Maxim notifies Myriad within [***] , the parties shall [***] . If Maxim [***] , then Myriad shall [***] ; provided, however , that for a period of [***] . For purposes of clarification, [***] .
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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6. FEES AND PAYMENTS
6.1 Upfront Fee. Myriad shall pay to Maxim a non-refundable, non-creditable upfront fee of [ *** ] within 20 days of the Effective Date.
6.2 Research Funding. During the Research Term, Myriad shall make research funding payments to Maxim for [***] FTEs per year, quarterly in advance, at the rate of [***] per FTE per year. The first payment under this Section 6.2 shall be made within 20 days of the Effective Date and each subsequent payment shall be made on the first day of each Calendar Quarter during the Research Term. The first and final quarterly payments shall be prorated to reflect the number of days in the calendar quarter that the Research Program is in effect. Any commitment by Maxim of more than [***] FTEs to the Research Program during the Research Term, and/or any extension of the Research Term beyond the second (2 nd ) anniversary of the Effective Date, would be subject to negotiation by the parties and require the mutual written agreement of the parties.
6.3 Milestone Payments. Within 30 days following the first occurrence of each of the events set forth below with respect to a Product, Myriad shall pay to Maxim the milestone payment set forth below (whether such milestone is achieved by Myriad, its Affiliate or any of their respective Sublicensees):
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Milestone Event |
Milestone Payment |
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|
Dosing of first patient in first Phase
1 |
$1,000,000 |
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
[***] |
[***] |
Each of the milestone payments described in this Section 6.3 shall be payable one (1) time for each Product containing a particular active ingredient, regardless of the number of indications for which such Product is developed or commercialized; provided, however, that if (a) a Product is abandoned during development after one (1) or more of the milestone payments under this Section 6.3 has been made (a “Dropped Product” ) and (b) another Product containing a different active ingredient is developed for substantially the same indication as a replacement for such Dropped Product, then only those milestone payments under this Section 6.3 that were not previously made with respect to such Dropped Product shall be payable with respect to the replacement Product. All payments made to Maxim pursuant to this Section 6.3 are non-refundable and, except as set forth in the preceding sentence, may not be credited against any other payments payable by Myriad to Maxim under this Agreement.
6.4 Royalties. Myriad shall pay to Maxim royalties on Net Sales of Products by Myriad and its Affiliates (but not their respective Sublicensees) at the following rates:
(a) [***] of that portion of total annual Net Sales of Products that is less than or equal to [***] ;
(b) [***] of that portion of total annual Net Sales of Products that is greater than [***] and less than or equal to [***] ;
(c) [***] of that portion of total annual Net Sales of Products that is greater than [***] and less than or equal to [***] ; and
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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(d) [***] of that portion of total annual Net Sales of Products that is greater than [***] .
6.5 Sublicensing Revenues.
(a) [***] Sublicense. Myriad shall pay to Maxim [***] of all Sublicensing Revenues received by Myriad or any of its Affiliates with respect to sublicenses of the right to develop, make, have made, use, distribute for sale, promote, market, offer for sale, sell, have sold, import or export Products [***] .
(b) [***] Sublicense. If Myriad grants to a Sublicensee the right to develop, make, have made, use, distribute for sale, promote, market, offer for sale, sell, have sold, import or export Products [***] , Myriad shall pay to Maxim milestone payments based on the achievement of any milestone set forth in Section 6.3 above by any such Sublicensee. Myriad shall also pay to Maxim royalties on the Net Sales of Products by all such Sublicensees [***] based on th






