Document:

Exhibit 10.19

 

CONFIDENTIAL MATERIAL OMITTED AND FILED

SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS DENOTE SUCH OMISSIONS.

 

PROCESS DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT

 

This Process Development and Manufacturing Services Agreement is entered into as of the 28th day of March, 2012 (the “Effective Date”), by and between Hovione Inter Limited, a Swiss corporation, having a principal place of business at Bahnhofstrasse 21 CH-6000 Lucerne 7 Switzerland (together with its Affiliates “Hovione”), and TESARO, Inc., a Delaware corporation, having a principal place of business at 1000 Winter Street, Suite 3300, Waltham, MA 02451 (“Client”).  Each of Hovione and Client may be referred to in this Agreement, individually, as a “Party” and, collectively, as the “Parties”.

 

Background

 

A.            Client is a biopharmaceutical company currently developing a product known as Rolapitant.

 

B.            Hovione is a contract manufacturer with the capabilities and facilities necessary to be able to provide process development and manufacturing services with respect to pharmaceutical products.

 

C.            Client desires to engage Hovione to provide certain process development services with respect to the manufacture of Rolapitant, and, if the manufacturing process is successfully implemented at Hovione, to manufacture Rolapitant in the quantities from time to time ordered by Client, and Hovione is willing to perform such services for Client, in each case subject to the terms and conditions set forth in this Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements contained in this Agreement, the Parties agree as follows:

 

SECTION 1.           DEFINITIONS.  As used in this Agreement, the following words and phrases will have the following meanings, whether used in the singular or plural:

 

1.1             “AAA” has the meaning set forth in Section 18.3.

 

1.2             “Affiliate,” as to a Party, means any entity which, directly or indirectly, controls, is controlled by, or is under common control with such Party.  For the purposes of this definition, “control” refers to any of the following: (i) direct or indirect ownership of fifty percent (50%) or more of the voting securities entitled to vote for the election of directors in the case of a corporation, or of fifty percent (50%) or more of the equity interest with the power to direct management in the case of any other type of legal entity; or (ii) any other arrangement where an entity possesses, directly or indirectly, the power to direct the management or policies of another entity, whether through ownership of voting securities, by contract or otherwise.  Notwithstanding the foregoing, the term “Affiliate” with respect to Client will not include New Enterprise Associates or any entity controlled by New Enterprise Associates other than the Client and its subsidiaries.

 

1.3             “Agreement” means this Process Development and Manufacturing Services Agreement, together with all Appendices attached hereto, Work Plans, and accepted Purchase Orders, as amended from time to time by the Parties in accordance with Section 20.2.

 

 

1.4             “Applicable Laws” means all laws, statutes, regulations, rules and guidances applicable to (a) activities performed under this Agreement in the jurisdiction where they are performed, other than activities described in clauses (b) and (c) of this paragraph, (b) Manufacturing in the jurisdiction of Manufacture, and (c) the supply, use, marketing or sale of Product in any jurisdiction where such Product is to be supplied, used, marketed or sold, including laws, statutes, regulations, rules and guidances related to Manufacture of Product that apply by reason of the supply, use, marketing or sale of Product in such jurisdiction; provided that, notwithstanding anything to the contrary in this Agreement, with regard to the supply, use, marketing or sale of Product, Product Manufactured by Hovione will only be required to comply with the applicable laws, regulations, guidelines, and directives, including cGMP, of (i) the FDA, the EMA, and PMDA, and (ii) such other comparable Regulatory Authority (ies) in the Territory as the Parties agree in writing, such agreement not to be unreasonably withheld, conditioned or delayed.

 

1.5             “Auditable Requirements Records” has the meaning set forth in Section 4.1(c).

 

1.6             “Batch” means a specific quantity of a Product that is intended to be of uniform character and quality and is produced during the same cycle of Manufacture in accordance with the Manufacturing Process in the amount and at the scale set forth in the applicable Master Batch Documentation.

 

1.7             “Batch Delivery Date” has the meaning set forth in Section 6.2.

 

1.8             “Batch Records” means the final executed batch production records for each Batch of Product Manufactured under this Agreement, prepared in accordance with cGMP, if applicable.

 

1.9             “Bulletin of Analysis,” as to any Batch of Product, means a certificate attesting to the results of testing of such Batch of Product against the criteria specified in relevant Product Specifications, and including test methods, specification parameters and the pass/fail criteria, used to show that a particular Batch of such Product meets Product Specifications and was Manufactured in accordance with the executed Batch Records.

 

1.10           “Calendar Quarter” means each three (3) month period commencing January 1, April 1, July 1 and October 1 during the Term.

 

1.11           “Cancellation Fee” has the meaning set forth in Section 5.7(b).

 

1.12           “Certificate of Analysis,” as to any Batch of Product, means a certificate attesting to the results of testing of such Batch of Product against the criteria specified in relevant Product Specifications, and including test methods, specification parameters and the pass/fail criteria, used to show that a particular Batch of such Product meets Product Specifications, and a statement attesting that a particular Batch of a Product was Manufactured in accordance with cGMP and the executed Batch Records.

 

1.13           “cGMP” means current good manufacturing practices applicable to the Manufacture of Product as follows: (i) current good manufacturing practices promulgated by the FDA, as specified in the United States Code of Federal Regulations and FDA’s guidance documents, as such practices govern the Manufacture of Product intended for use in the United States; (ii)  current good manufacturing practices as defined in the Q7A Guidance on Good Manufacturing Practices of the International Conference on Harmonization of Technical 

 

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Requirements of Pharmaceuticals for Human Use (ICHQ7A) and other ICH guidelines applicable to the manufacture of the drug substance; (iii) current good manufacturing practices or equivalent standards promulgated by Regulatory Authorities of Japan; and (iv) current good manufacturing practices or equivalent standards promulgated by such other countries of the Territory in which Product is intended to be supplied, used, marketed or sold and which other countries are agreed to in writing between the Parties, such agreement not to be unreasonably withheld, conditioned or delayed.

 

1.14           “Change Order” means a written description of a change in the scope of Services or other terms specified in a Work Plan or in the prices or payment schedule for such Work Plan as executed by both Parties in accordance with Section 2.3, but not including changes to Purchase Orders for Manufacture of commercial supplies of Product which are covered by Section 5.6(b).

 

1.15           “Client Background Intellectual Property” means Client Background Know-How and Client Background Patent Rights.

 

1.16           “Client Background Know-How” means any and all inventions, discoveries, trade secrets, processes, process improvements, procedures, materials, components, designs, documentation, technical data, analytical information and other data, information and know-how whether or not protectable under patent, trademark, copyright or similar law, that are either generated, owned or controlled (with the right to sublicense) by Client or any of its Affiliates, with the right to sublicense, (i) prior to the Effective Date or (ii) independent of this Agreement and without the use of the Confidential Information of Hovione or Hovione Background Know-How.

 

1.17           “Client Background Patent Rights” means any and all U.S. and foreign patents and patent applications, including divisions, continuations, continuations-in-part, additions, renewals, extensions, re-examinations and reissues, if any, owned by Client or any of Client’s Affiliates, or controlled by Client or any of its Affiliates (i) prior to the Effective Date, or (ii) arising independently of this Agreement, including after the Effective Date, and without the use of the Confidential Information of Hovione or Hovione Background Know-How.

 

1.18           “Client Indemnified Parties” has the meaning set forth in Section 14.2.

 

1.19           “Client-Supplied Materials” means the specific raw materials, ingredients, and other materials to be provided by Client, as listed in Appendix A or the applicable Work Plan, as updated by Client in writing, from time to time.

 

1.20           “CMC Documentation” means the chemistry, manufacturing and controls section of a Regulatory Filing.

 

1.21           “Commercial Supply Election” has the meaning set forth in Section 4.1(a).

 

1.22           “Confidential Information” as to Client means (i) any information of a confidential or proprietary nature, including, but not limited to, scientific, technical, trade and business information, provided by or on behalf of Client to Hovione under the CDA or this Agreement; (ii) subject to Section 9.6 and excluding any Proprietary Formats contained in the following, the Master Batch Documentation, Batch Records and other Development Deliverables; (iii) any Product-Related Know-How; (iv) Client’s development plans and timelines related to Product; and (v) other information generated by Hovione in the course of 

 

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Services that is specific to Product and not related to manufacture of other product, in each case, whether or not labeled or identified as confidential.  “Confidential Information” as to Hovione means (y) any information of a confidential or proprietary nature, including, but not limited to, any scientific, technical, trade and business information, provided by or on behalf of Hovione to Client or any of its Affiliates under the CDA or this Agreement, but not including the Development Deliverables (except for Proprietary Formats in any Development Deliverables) or Product-Related Know-How and (z) Hovione Background Intellectual Property and Hovione Improvements, in each of (y) and (z) whether or not labeled or identified as confidential.

 

1.23           “Costs Savings” has the meaning set forth in Section 7.4.

 

1.24           “Costs Savings Target” means *.

 

1.25           “Deficiency Notice” has the meaning set forth in Section 6.4.

 

1.26           “Development Deliverables” means (i) the Product Specifications; (ii) Master Batch Documentation; (iii) Batch Records; (iv) procedures, processes, protocols and analytical methods developed in the performance of the Services that are solely related to Product; (v) technical reports prepared as part of Services; and (vi) other deliverables specified in a Work Plan which may include, but shall not be limited to, raw data and in-process controls (IPC)  results.

 

1.27           “Development Fees” has the meaning set forth in Section 7.1.

 

1.28           “Development Services” means the activities related to technology transfer; process development, including particle design; process validation; CMC Documentation preparation; analytical development and validation, stability testing, scale-up and other services related to the Manufacture of Product, as described in the Work Plan attached to this Agreement as Appendix D or in any additional Work Plan executed by the Parties in accordance with Section 2.1, but not including Manufacturing Services.  For the sake of clarity, the Manufacture of Product for clinical studies, if requested by Client, will be performed as part of Development Services under a mutually agreed upon Work Plan.  Manufacture of commercial supplies, to the extent Client elects to proceed under Section 4.1, will be part of Manufacturing Services.

 

1.29           “Disclosing Party” has the meaning set forth in Section 11.1.

 

1.30           “Dispute” has the meaning set forth in Section 18.2.

 

1.31           “EMA” means the European Medicines Agency, or any successor entity thereto.

 

1.32           “Executive Officers” has the meaning set forth in Section 18.2.

 

1.33           “Facilities” means the Hovione facility used in the conduct of Services, as specified in the applicable Work Plan and any other Hovione facility approved in writing by Client prior to use in the performance of Services.

 

1.34           “FDA” means the United States Food and Drug Administration, or any successor entity thereto.

 

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1.35           “Force Majeure Event” has meaning set forth in Section 19.

 

1.36           “Hovione Background Intellectual Property” means Hovione Background Know-How and Hovione Background Patent Rights.

 

1.37           “Hovione Background Know-How” means any and all inventions, discoveries, trade secrets, designs, processes, process improvements, procedures, materials, components, documentation, technical data, analytical information, and other data and the like, information and know-how whether or not protectable under patent, trademark, copyright or similar law, that are either generated, owned or controlled (with the right to sublicense) by Hovione (i) prior to the Effective Date, or (ii) arising independently of this Agreement and without the use of the Confidential Information of Client or Client Background Know-How.

 

1.38           “Hovione Background Patent Rights” means any and all U.S. and foreign patents and patent applications, including divisions, continuations, continuations-in-part, additions, renewals, extensions, re-examinations and reissues, if any, owned by Hovione, or controlled by Hovione (with the right to sublicense) (i) prior to the Effective Date, or (ii) arising independent of this Agreement and without the use of the Confidential Information of Client or Client Background Know-How.

 

1.39           “Hovione Improvements” means any and all inventions, discoveries, know-how, trade secrets, processes, process improvements, procedures, materials, components, designs, information, data and the like, whether or not protectable under patent, trademark, copyright or similar law, that are generated, conceived, developed, created, invented, made or reduced to practice solely by or on solely on behalf of Hovione by any Third Party engaged by Hovione in the conduct of Development Services or Manufacturing Services under this Agreement other than Product-Related Improvements.

 

1.40           “Hovione Indemnified Parties” has the meaning set forth in Section 14.1.

 

1.41           “Hovione Personnel” has the meaning set forth in Section 15.2.

 

1.42           “Independent Expert” has the meaning set forth in Section 6.5.

 

1.43           “Initial Order Date” has the meaning set forth in Section 5.3.

 

1.44           “Inspection Period” has the meaning set forth in Section 6.4.

 

1.45           “Joint Project Team” has the meaning set forth in Section 2.6.

 

1.46           “Launch Date” means the date of the first commercial sale in a country within the Territory following regulatory approval in such country, by Client or its Affiliates or their respective designees in the Territory of Product Manufactured in accordance with this Agreement or a product containing or comprised of Product.

 

1.47           “Liability” has the meaning set forth in Section 14.1.

 

1.48           “Manufacture”, “Manufacturing” or “Manufactured” will mean all steps, processes and activities of Hovione to produce Product (or any step, process or activity therein), including the manufacture, production, Materials sourcing, other than Client-Supplied Materials, and testing as applicable, packaging, labeling, warehousing, quality control testing 

 

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(including in-process, release and stability testing, when applicable), release, preparation for shipping and storing of any Product, either as part of Development Services or Manufacturing Services.

 

1.49           “Manufacturing Documents” has the meaning set forth in Section 2.2.

 

1.50           “Manufacturing Process” means any and all processes and activities (or any step in any process or activity) used or intended to be used in the Manufacture of a Product as described in the Master Batch Documentation.

 

1.51           “Manufacturing Services” means, subject to Section 4.1, the Manufacture by Hovione of commercial Batches of Product ordered by Client after Process Validation Completion.

 

1.52           “Manufacturing Standards” means, with respect to the Manufacture of a Product that the Product: (i) has been Manufactured in accordance with the Master Batch Documentation and in accordance with the applicable Quality Agreement; (ii) at the time of delivery conforms to the agreed upon Product Specifications; and (iii) has been prepared for shipment in accordance with the procedures and requirements mutually agreed upon by the Parties; (iv) has been Manufactured in accordance with Applicable Laws including, cGMP (if applicable).

 

1.53           “Master Batch Documentation”, as to a Product, means the documents that specify or reference the complete set of formal instructions for the Manufacture of such Product, including Material descriptions, in process testing and finished Product Specifications developed and mutually approved by Hovione and Client under the terms of this Agreement, as amended from time to time by in accordance with Section 8.3.

 

1.54           “Material Gain” means, for the relevant period, the amount by which (a) the quantity of Client-Supplied Materials used to Manufacture Product in the relevant period is less than (b) the specified range of the quantity of Client-Supplied Materials that would be used to Manufacture the same amount of Product at the standard per kilogram input as set forth in the Validation Report, and is the difference between (a) and (b).

 

1.55           “Material Loss” means, for the relevant period, the aggregate amount of Client-Supplied Materials lost in such period (a) in the performance of Services by Hovione, or any of its agents, subcontractors or employees or, subject to Section 6.6(e), failure of Product to meet the Manufacturing Standards, or (b) as a result of any Yield Loss, in each case using as a base line the specified range of the quantity of Client-Supplied Material used to Manufacture a kilogram of Product as set forth in the Validation Report.

 

1.56           “Material Specifications” means the specifications for Materials including, but not limited to, written release specifications and testing instructions, as specified in the Master Batch Documentation or as otherwise mutually agreed upon in writing by the Parties.

 

1.57           “Materials” means any key starting materials and other raw materials and ingredients used in the Manufacture of a Product including Client-Supplied Materials.

 

1.58           “Minimum Purchase Obligation” means seventy percent (70%) of the total quantity of Product purchased by Client for commercial sale in the Territory on an annual basis during the Term, subject to adjustment in accordance with Section 4.1; provided that, Client may 

 

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designate up to 20% of Product purchased on an annual basis as “safety stock” and such safety stock shall not be deemed to be “for commercial sale” for the purposes of calculating the percentage of the total quantity of Product purchased by Client hereunder.

 

1.59           “PMDA” means the Pharmaceuticals and Medical Device Agency in Japan, or any successor entity thereto.

 

1.60           “Process Validation Completion” means the date on which Client provides written notice of approval of the validation report documenting the successful completion by Hovione of the validation of the Manufacturing Process for the Product in accordance with the validation master plan approved in writing by both Parties which notice shall be no later than * days after Hovione submits such report to Client.  For the sake of clarity, Client shall have no obligation to provide such approval if the report documents other than successful completion of the validation of the Manufacturing Process, as determined by Client, acting reasonably.

 

1.61           “Product” means the product described in Appendix C, as amended from time to time by mutual written agreement of the Parties.

 

1.62           “Product Consumption Report” has the meaning set forth in Section 4.1(b).

 

1.63           “Product-Related Improvements” means Product-Related Know-How and Product-Related Patent Rights.

 

1.64           “Product-Related Know-How” means any and all inventions, discoveries, know-how, trade secrets, designs, processes, process improvements, procedures, materials, components, information, data, and the like, whether or not protectable under patent, trademark, copyright or similar law, that are generated, conceived, developed, created, invented, made or reduced to practice by or on behalf of Hovione or any Third Party engaged by Hovione in the conduct of Development Services or Manufacturing Services under this Agreement that (i) constitute an improvement, modification or new use of Product; (ii) constitute an improvement or modification to the Manufacturing Process for Product that is specific to Product; or (iii) constitute an improvement or modification to Client Background Know-How.

 

1.65           “Product-Related Patent Rights” means any and all United States and foreign patents and patent applications, including divisions, continuations, continuations-in-part, additions, renewals, extensions, re-examinations and reissues, covering inventions included within Product-Related Know-How, and any extensions and supplemental protection certificates with respect to any of the foregoing.

 

1.66           “Product Specifications”, as to a Product, means the written release specifications, as mutually agreed upon in writing by the Parties in the course of the Development Services, and as amended from time to time by mutual agreement of the Parties in accordance with Section 8.2.

 

1.67           “Project Manager” has the meaning set forth in Section 2.6(b).

 

1.68           “Proprietary Format” means those proprietary document formats of Hovione as are expressly listed in Appendix E, but solely with respect to the corresponding document as listed on Appendix E, provided that a format will not be treated as a Proprietary Format if it is included in a document that is in the public domain or made available by Hovione to Third Parties on non-confidential basis.

 

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1.69           “Purchase Order” means any order instructions, including quantity of Product ordered, delivery date, and shipping instructions, submitted by Client or any of its Affiliates for commercial supply of a Product in accordance with Section 5.7.

 

1.70           “Quality Agreement” has the meaning set forth in Section 6.3.

 

1.71           “Receiving Party” has the meaning set forth in Section 11.1.

 

1.72           “Records” has the meaning set forth in Section 8.14.

 

1.73           “Regulatory Authority” means the FDA, the EMA the PMDA or any other governmental or regulatory body, agency authority or entity which regulates, directs or controls the manufacture, clinical testing, commercialization or use of pharmaceutical products in, or with respect to, the country of manufacture or sale within the Territory which are agreed to in writing between the Parties, such agreement not to be unreasonably withheld, conditioned or delayed.

 

1.74           “Regulatory Filings” means the governmental filings required to obtain approval to conduct clinical trials of a Product, or to market and sell a Product in a given country within the Territory, including, but not limited to, Product registrations and Product marketing approvals, as applicable, in each such country.

 

1.75           “Response Date” has the meaning set forth in Section 6.5.

 

1.76           “Response Notice” has the meaning set forth in Section 6.5.

 

1.77           “Retention Period” has the meaning set forth in Section 8.14.

 

1.78           “Rolling Forecast” has the meaning set forth in Section 5.4.

 

1.79           “Services” means Development Services and Manufacturing Services.

 

1.80           “Shipping Instructions” means the standards and other requirements for the packaging and preparation of the Product for shipment that are mutually agreed to in writing by the Parties.

 

1.81           “Supply Failure” means (i) any notification from Hovione under Section 5.7 of an anticipated Product shortage or inability to fill a Purchase Order in either case for a period of * days or more from the agreed upon delivery date; (ii) a Force Majeure Event affecting Hovione’s ability to supply Product that meets the Manufacturing Standards in accordance with this Agreement for a period of * days or more from the agreed upon delivery date; (iii) a material breach by Hovione of its supply obligation under this Agreement which such breach is not cured for a period of * days of receipt of written notice from Client; or (iv) the occurrence on more than two (2) occasions within a twelve month period of a material breach by Hovione of its obligation to supply Product that meets the Manufacturing Standards whether or not such breach has been cured.

 

1.82           “Supply Price” shall have the meaning set forth in Section 7.2.

 

1.83           “Supply Price Target” means: *

 

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1.84           “Target Yield” means the target Yield using the specified ranges of the quantities of Client-Supplied Materials established after Process Validation Completion and updated annually by mutual written agreement of the Parties based on the historical performance of the Manufacturing Process during the Parties’ annual product quality review meeting.

 

1.85           “Technology Transfer” has the meaning set forth in Section 10.2(a).

 

1.86           “Term” has the meaning set forth in Section 12.1.

 

1.87           “Territory” means the United States, European Union, Japan, Canada, India, Brazil, Australia, New Zealand, Russia, China, and South Korea and such other countries as are specified in a Work Plan or as agreed to in writing between the Parties, such agreement not to be unreasonably withheld, conditioned or delayed.

 

1.88           “Third Party” or “Third Parties” means any person or entity, as applicable, other than Client or Hovione or any of their respective Affiliates.

 

1.89           “Work Plan” means a written order for the performance of Services by Hovione under this Agreement, in substantially the form attached hereto as Appendix B, signed by duly authorized representatives of both Parties and referencing this Agreement.   The initial Work Plan is attached as Appendix D to this Agreement.

 

1.90           “Yield” means the quantity of Product obtained that conforms to Product Specifications (if applicable) and has been Manufactured in accordance with the Manufacturing Standards.

 

1.91           “Yield Loss” applies if (a) the amount of Product Manufactured in the relevant period is below (b) the amount that would be expected to be Manufactured using the same quantity of Client-Supplied Materials at the Target Yield, and means the difference between (a) and (b).

 

SECTION 2.           DEVELOPMENT SERVICES.

 

2.1             Development Services.  Subject to the terms and conditions of this Agreement and the applicable Work Plan, Hovione will perform technology transfer, process and analytical development, process and analytical validation, CMC Documentation preparation, Manufacture of demonstration batches, validation batches, registration batches and clinical supplies, stability studies and other Development Services, as may be, from time to time, set forth in one or more Work Plans, and deliver to Client the corresponding Product or other Development Deliverables, in each case in accordance with the timelines and specifications for performance set for in the applicable Work Plan and in this Agreement.  The initial Work Plan is attached as Appendix D.  Each Work Plan executed under this Section shall contain the material terms for Development Services specifically requested by Client, and agreed upon by Hovione, the fees and payment schedule for such Development Services, the schedule for performance and the deliverables, and such other details and special arrangements agreed to by the Parties.  Once executed, the Work Plan is subject to the terms and conditions of this Agreement and incorporated herein in its entirety, and any changes or additions to a Work Plan, including, but not limited to changes in scope, fees and timing shall be made by a Change Order in accordance with Section 2.3.  In the event of any conflict between this Agreement and any Work Plan, this Agreement shall control, except to the extent that the Work Plan expressly specifies that a particular provision in the Work Plan will take precedent over this Agreement.

 

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2.2             Manufacturing Documents for Approval.  As part of Development Services, Hovione shall deliver to Client the Master Batch Documentation, the Product Specifications, Product-specific procedures, protocols and technical reports, and such other documents as are specified in the applicable Work Plan, including but not limited to, raw data and IPC results (the “Manufacturing Documents”).  Drafts of all Manufacturing Documents and such other documents as are to be approved in writing by Client, as specified in the Quality Agreement or agreed to by the Joint Project Team, will be provided to Client for approval at least * days in advance of commencement of the first cGMP Batch or on such other schedule as the Joint Project Team agrees.

 

2.3             Change Orders.  Any changes in, or additions to, a Work Plan, including changes to specific assumptions set forth in such Work Plan, scope, fees, and timing, will be made only by mutual written agreement of the Parties.  In the event Hovione reasonably believes that any activity requested by Client constitutes a change in the scope of the Work Plan or otherwise identifies the need for a Change Order, Hovione will provide Client with a proposed Change Order (which, if it includes a change in any payment amounts shall be commercially reasonable in light of the change in scope).  When the Parties agree on a written Change Order documenting such change in scope and any agreed upon changes in the payment amounts,  it shall be effective upon execution by authorized representatives of both Parties, provided that Client may, in writing, authorize Hovione to proceed with a change pending final agreement on and execution of the applicable Change Order.

 

2.4             Compliance.  In performing Development Services under this Agreement, Hovione will comply with all Applicable Laws and generally accepted industry standards, and any protocols, guidelines, instructions, processes and procedures referenced in the applicable Work Plan (provided the same do not violate any Applicable Laws and/or generally accepted industry standards), and the Manufacturing Documents, to the extent applicable, or mutually agreed to in writing signed by both Parties.  If requested by Client in a Work Plan or Change Order, Hovione will comply with all reasonable and applicable guidelines and instructions that Client provides that do not conflict with Applicable Laws, and provided that in no event will Hovione be required to reform its cGMP documentation unless such documentation does not comply with cGMP or change any of its policies if such change would result in Hovione not complying with cGMP.  In the event that a Work Plan specifies that a protocol applicable to Development Services must be agreed upon by both Parties, Hovione will provide such protocol to Client at least * business days’ prior to commencement of the relevant Development Services.  Hovione will perform Development Services in accordance with the timelines set forth in the applicable Work Plan provided that timelines may be extended to accommodate any material delays in Client document review or other material delays originating from Client communications required by this Agreement. Client acknowledges that timelines in Work Plans are dependent upon: (i) timely reviews and approvals by Client, and (ii) Client maintaining a sufficient inventory of Client-Supplied Materials as required by Section 5.5.  In the event that Client’s material delay is longer than * weeks, Hovione will be entitled, at its sole option, to reallocate resources otherwise reserved for the performance of those Services without penalty.  Notwithstanding the foregoing sentence, Hovione will use commercially reasonable efforts to promptly recommence Services based on availability of resources at the time of the conclusion of said delay taking into account its other contractual commitments.  In the event there is a dispute between Client and Hovione regarding the schedule for recommencing Services pursuant to the foregoing sentence, the Parties will work together in good faith to resolve such dispute pursuant to the dispute resolution provisions of Section 18.2.  Hovione will use commercially reasonable efforts to ensure that the data, reports, Development Deliverables and other results of Development Services provided to Client under this Agreement are truthful and 

 

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accurate in all respects.  Hovione acknowledges that, subject to the obligations of Client under clauses (i) and (ii) of this Section 2.4, time is of the essence with regard to the performance of Services under this Agreement, including the date of delivery by Hovione of any Product.

 

2.5             Reports.  While Services under any Work Plan are ongoing, Hovione will provide to Client, on a monthly basis, or at such other frequency as is set forth in the applicable Work Plan or agreed upon by the Joint Project Team, detailed written reports on the status and results to date of the Development Services.  Hovione will provide a final report describing in detail the results of Development Services under a Work Plan within * days of completion of all activities under such Work Plan or on such other schedule as is set forth in such Work Plan or as the Parties otherwise mutually agree in writing.  Reports provided under this Section sentence will be in such format as determined by the Joint Project Team.

 

2.6             Governance.

 

(a)                 Joint Project Team.  During the Term, the Parties will maintain a Joint Project Team (the “Joint Project Team”) comprised of * representatives from each Party *.  The Project Manager of each Party shall be a member of the Joint Project Team.  The Joint Project Team will be responsible for coordinating the Development Services and making recommendations to Client with respect to the implementation of Work Plan activities before and during Process Validation Completion, and will provide a forum for communication regarding Manufacturing activities after Process Validation Completion.  The Joint Project Team will not have any ability to make any changes to the terms and conditions of this Agreement, including, but not limited to, any Work Plan.  Each Party’s representative(s) on the Joint Project Team will have the appropriate technical knowledge and expertise as relevant to the activities allocated to such Party under this Agreement.  Additional attendees may attend meetings of the Joint Project Team at the discretion of either who wants such attendee to attend, subject to the confidentiality obligations set forth in Section 11.  The Joint Project Team will meet, twice each month, in person or by phone, during the course of performance of Development Services and after completion of all Development Services will meet quarterly or at such other frequency as the Parties mutually agree.  Each Party will bear its own expenses related to the participation of its representatives on the Joint Project Team.  Each Party may change its designees on the Joint Project Team, in its sole discretion, upon written notice to the other Party.

 

(b)                 Project Manager.  Each Party has designated a representative (the “Project Manager” who will act as the primary interface for interactions with the other Party related to activities under this Agreement.  Each Party may replace its Project Manager upon written notice to the other Party. The Project Managers will communicate on a regular basis and make themselves reasonably available for purposes of this Agreement.

 

(c)                 Annual Meeting.  At least annually and at such other reasonable times, upon request by either Party, designees of the senior management teams of both Parties will meet to discuss the overall business relationship of the Parties, and to discuss areas for improvement and planning for future activities.

 

2.7             Non-competition.  Hovione will not for itself or any of its Affiliates, nor shall it provide to any Third Party, directly or indirectly, any development, consulting, validation, contract manufacturing or any other services with respect to any product that incorporates the same active pharmaceutical ingredient as the Product during the Term of this Agreement and for a period of * thereafter, except that with respect to Third Parties, Hovione may provide such 

 

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service to a Third Party that Client confirms to Hovione in writing has the necessary rights from Client to, manufacture, have manufactured and/or develop or have developed the product containing such active pharmaceutical ingredient, such written confirmation not to be unreasonably withheld, conditioned, or delayed.

 

SECTION 3.           CLIENT RESPONSIBILITIES

 

3.1             Process Information; Client Background Know-How.  Client will be responsible for (i) providing Hovione with such Client Background Know-How and other information as is specified in each Work Plan as to be provided by Client or such other Client Background Know-How reasonably requested by Hovione as is readily accessible to Client and necessary for Hovione to perform Services; and (ii) ensuring that such information is complete and accurate in all material respects; and (iii) reviewing and approving the Manufacturing Documents prepared by Hovione.

 

3.2             Client-Supplied Materials.  Except as expressly set forth in this Agreement or in a Work Plan or as otherwise agreed upon by the Parties, Client will be responsible for sourcing and providing to Hovione all Client-Supplied Materials, *, for all Development Services and Manufacturing Services.  Hovione’s requirements for Client-Supplied Materials and the dates by which such Client-Supplied Materials must be provided to Hovione for the commencement of the applicable Services (a) will be set forth in the applicable Work Plan or otherwise mutually agreed to in writing for Development Services, and (b) is set forth in Section 5.5 for Manufacturing Services.  Notwithstanding anything in this Agreement to the contrary, Hovione will not be in breach of its obligation to supply Product or perform Services by the agreed to delivery date and it will not constitute a Supply Failure if the delivery or performance delay is substantially the result of Client’s failure to meet its material obligations in accordance with the terms of this Agreement; provided that, if such failure is reasonably likely to cause the delivery or performance delay, Hovione promptly notifies Client thereof and provides Client with a reasonable estimate of the delay and Hovione uses all reasonable efforts to mitigate the delay.  Hovione will promptly advise Client in writing of any Client-Supplied Materials that are lost or damaged, including any Material Loss.

 

3.3             Client Personnel.  Client will be responsible for providing Hovione with reasonable access to knowledgeable Client personnel for consultation regarding Client Background Know-How, Confidential Information of Client, Client-Supplied Materials and the Services.

 

3.4             Notice of Hazardous Materials.  Prior to Hovione commencing the Services, Client shall inform Hovione of all material characteristics, including all health and safety characteristics, of the Client-Supplied Materials to the extent known by Client, and when appropriate, provide Hovione with a Material Safety Data Sheet on Client-Supplied Materials and Product.  Client shall promptly notify Hovione of any new hazards or potential new hazards to the health and safety of Hovione personnel relating to the Client-Supplied Materials or Product of which Client becomes aware.

 

SECTION 4.           MANUFACTURING SERVICES.

 

4.1             Manufacture and Sale of Product.

 

(a)                 General. Unless terminated in accordance with Section 12.2(a), 12.2(b),  or 12.2(c) or Section 12.3. Client will be deemed to have elected to have Hovione perform 

 

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Manufacturing Services (“Commercial Supply Election”).  In the event the Commercial Supply Election has occurred, then, commencing upon agreement by the Parties of a Supply Price, Client will, except as otherwise set forth in this Agreement, be required to purchase no less than the Minimum Purchase Obligation from Hovione each calendar year during the remainder of the Term in accordance with the terms of this Agreement or reimburse Hovione for the shortfall under Section 4.1(b).  Notwithstanding the foregoing, the Minimum Purchase Obligation shall no longer apply for periods commencing after the first occurrence of either of the following:  (i) the Supply Price exceeds the Supply Price Target, or (ii) a Supply Failure. Client will not be responsible for any failure to purchase the Minimum Purchase Obligation arising from a breach by Hovione of its obligations under this Agreement, whether or not cured.

 

(b)                 Product Reports.  Within * days after the end of each calendar year during the Term, Client will provide to Hovione a report (the “Product Consumption Report”) in a form mutually agreed by the Parties setting forth (i) the total quantity of Product purchased by Client for commercial sale in the Territory in the immediately preceding calendar year; (ii) based on the foregoing, the Minimum Purchase Obligation under this Agreement for the applicable calendar year; and (iii) the total amount of Product purchased from Hovione under this Agreement during the applicable calendar year.  Further, if requested in writing by Hovione at least * business days prior to issuance of a given Product Consumption Report, Client shall have such Product Consumption Report signed by a duly authorized representative of Client.  If any such Product Consumption Report shows that Client has not met its Minimum Purchase Obligation, if any, with respect to a given calendar year then Client will include with such Product Consumption Report a payment to Hovione at the Supply Price in effect at the end of such calendar year for the requirements shortfall.

 

(c)                 Requirements Records.  Client shall keep complete and accurate written records in connection with Minimum Purchase Obligation.  Such records shall be in sufficient detail to permit verification of all Product Consumption Reports provided by Client pursuant to Section 4.1(b), and shall be maintained and may be audited for a period of * from the end of the calendar year to which they relate (the “Auditable Requirements Records”).  Upon * business days prior written notice from Hovione, Client shall permit Hovione’s Third Party auditors to examine and audit such Auditable Requirements Records during normal business hours, * to verify the accuracy of all amounts reported to Hovione by Client in such Product Consumption Reports.  Hovione’s Third Party auditors must be from a nationally (i.e., United States) known independent audit firm.  If an audit under this Section 4.1(c) reveals that Client has not met its obligations for the applicable calendar year, either through purchases made during the calendar year or the shortfall payment specified in Section 4.1(b), then unless Client disputes the finding in such audit report by providing written notice to Hovione within * days of receipt of such written audit report, Client shall, within * days after Client receives the written audit report so concluding, make to Hovione a payment at the Supply Price in effect at the end of the relevant calendar year for any shortfall not already covered by Section 4.1(b).  * shall bear the costs and fees associated with any audit under this 4.1(c); provided, however, that if such audit demonstrates that Client has not met its minimum purchase obligations under 4.1(a) and/or shortfall payment obligations under Section 4.1(b) by greater than * of the Minimum Purchase Obligation, then the costs and fees associated with the audit shall be paid by *.  Any audit under this 4.1(c) conducted by or on behalf of Hovione shall not relieve either Party from any of its obligations or liabilities under this Agreement.  Hovione’s right to examine or have such Auditable Requirements Records examined shall survive termination or expiration of this Agreement, solely to the extent necessary to provide Hovione with the rights set forth in the first sentence of this subsection (c).

 

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4.2             Materials.  Except as set forth in Section 3.2, Hovione will purchase, *, all Materials and equipment used in Manufacturing Services which cost shall be *.  All such Materials will conform to the applicable Materials Specifications.  The Materials identified in Appendix F will be supplied by Client-approved suppliers.

 

4.3             Inventory.  Hovione will maintain an inventory of Materials in a minimum amount to be determined by mutual agreement of the Parties based on the recommendation of the Joint Project Team, such agreement not to be unreasonably withheld.

 

4.4             Use of Third Parties.  Hovione will not utilize any Third Party to Manufacture all or any portion of the Product except as permitted in accordance with Section 16(b).

 

SECTION 5.           ORDERS AND FORECASTS.

 

5.1             First Year Estimate.  Within * days after the Commercial Supply Election, if any, Client will provide Hovione with a written nonbinding estimate of Client’s quarterly requirements of the initial Product to be ordered from Hovione as part of Manufacturing Services for the then current Calendar Quarter and the following three Calendar Quarters.

 

5.2             First Order.  Hovione and Client will cooperate fully in estimating and scheduling production for Client’s first order of Product as part of Manufacturing Services.

 

5.3             First Firm Order.  On not fewer than * calendar days in advance of the desired Product availability date after Process Validation Completion or on such other schedule as agreed upon by the Joint Project Team (the “Initial Order Date”), Client will place its first firm Purchase Order for Product (the “Initial Order”).  At the same time, Client will provide to Hovione a nonbinding estimate of Client’s quarterly requirements of Product to be supplied by Hovione as part of Manufacturing Services for the next succeeding * calendar month period.

 

5.4             Rolling Forecast.  At the beginning of each Calendar Quarter during the Term following the Initial Order Date, Client will provide to Hovione a rolling * month projection of its requirements of Product to be supplied by Hovione (the “Rolling Forecast”).  Commencing with Rolling Forecasts provided after a Commercial Supply Election, the first  * quarters of a Rolling Forecast will be a binding commitment to purchase, and the remainder of such Rolling Forecast will be nonbinding. For the sake of clarification, in each updated Rolling Forecast after a Commercial Supply Election, the first 1st and 2nd quarter binding commitment shall be identical in quantity to the quantity shown for the same quarter on the Rolling Forecast provided in the immediately preceding Calendar Quarter unless mutually agreed to between the Parties in writing.

 

5.5             Client Supplied Materials.  Commencing upon a Commercial Supply Election, Client agrees to use commercially reasonable efforts to build, over time, an inventory of Client-Supplied Materials at the Facility to support * of the Rolling Forecast, and will, at a minimum, provide Client-Supplied Materials to Hovione sufficient to enable Hovione to manufacture the then current binding portion of the Rolling Forecast at least *calendar days in advance of said requirement.

 

5.6             Purchase Orders.

 

(a)                 Client will submit Purchase Orders for each order for the Manufacture and supply of Product as part of Manufacturing Services at least * days in advance of the requested 

 

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delivery date for such Product.  The Purchase Order will be accepted in writing within * business days of its receipt by Hovione confirming acceptance of the Purchase Order.  Hovione may not withhold its acceptance of a Purchase Order unless the supply price is inconsistent with the Supply Price as calculated in accordance with Sections 7.2 and 7.3 or the quantity ordered would cause the total amount ordered by Client in the applicable Calendar Quarter to be more than * of the amount shown for such Calendar Quarter in the Rolling Forecast provided at the beginning of the immediately prior Calendar Quarter or the Purchase Order otherwise fails to comply with the terms of this Agreement.  Hovione shall deliver to Client the quantity of Product specified in each accepted Purchase Order on the date specified in each accepted Purchase Order, unless Hovione is not able to do so solely due to any act or omission of Client.  Each accepted Purchase Order or any acknowledgment thereof, whether printed, stamped, typed, or written will be governed by the terms of this Agreement and none of the provisions of such Purchase Order or acknowledgment will be applicable except those specifying Product and quantity ordered, delivery location, delivery dates, special shipping instructions and invoice information.

 

(b)                 Changes to Purchase Orders.  Client may cancel an accepted Purchase Order for commercial supplies of Product upon written notice to Hovione, subject to payment of a cancellation fee (a “Cancellation Fee”) as follows:

 

(i)        In the event Client provides written notice of cancellation to Hovione less than * calendar days, but more than * calendar days prior to the proposed delivery date, Client will pay Hovione * of the Supply Price for the total amount of Product ordered under the cancelled portion of the order;

 

(ii)       In the event Client provides written notice of cancellation to Hovione less than * calendar days, but more than * calendar days prior to the proposed delivery date, Client will pay Hovione * of the Supply Price for the total amount of Product ordered under the cancelled portion of the order; and

 

(iii)      In the event Client provides written notice of cancellation * calendar days or more prior to the proposed delivery date, then *.

 

Hovione will provide Client with an estimated, non-binding target date on which the Manufacture of a Batch under a Purchase Order will commence; such target date shall be based upon the relevant Forecast provided by Client.  However, notwithstanding anything to the contrary in this subsection (b), if a Purchase Order is cancelled after Manufacture has commenced, Client will pay Hovione * of the Supply Price for the total amount of Product ordered under the cancelled order.  For purposes of this Section 5.6, the Manufacture of a Batch of Product shall conclusively be deemed to have commenced when the first materials for such Batch have been charged to a reactor.

 

5.7             Notice of Inability to Supply.  Hovione shall notify Client within * days of (i) any damage to the Facility that will or may affect or delay Hovione’s ability to Manufacture Product under this Agreement; or (ii) the occurrence of any other event that may or will impact Hovione’s ability to fill an accepted Purchase Order by the requested delivery date.  The foregoing will not be deemed a limitation on Hovione’s obligations or the rights of Client under this Agreement.

 

5.8             Product Title and Shipment.  Any Product Manufactured by Hovione pursuant to this Agreement will, after release by Hovione, or, at Client’s request under quarantine pending 

 

15

 

final release by Hovione (i) be packaged and prepared for shipment in accordance with the Shipping Instructions), and delivered FCA the Facility (Incoterms 2010), or (ii) be stored by Hovione at the Facility, as requested by Client and agreed by Hovione in advance in writing.  Title and risk of loss will pass to Client in accordance with FCA (Incoterms 2010) upon delivery of Product, or upon release of Product by Hovione, if Product is, at Client’s request, stored by Hovione.  Product will be shipped via a carrier designated in writing by Client, and will be packaged for delivery in accordance with the Shipping Instructions to the location specified by Client in the applicable Purchase Order.

 

5.9             Storage.  Hovione will maintain all Products stored by Hovione in accordance with the storage specifications for the Product as agreed upon between the Parties in writing.

 

5.10           Invoices.  Hovione will be entitled to send invoices to Client with respect to a Batch of Product upon the issuance by Hovione to Client of the Certificate of Analysis or Bulletin of Analysis, as described in an applicable Work Order, for the Batch but not earlier than the specified delivery date of the Product to Client.  Subject to Section 6.6, invoices are payable by Client in accordance with Section 7.4.

 

5.11           Conflicts.  In the event of any conflict between this Agreement and any accepted Purchase Order or issued invoice, the terms of this Agreement shall control.

 

SECTION 6.           QUALITY CONTROL.

 

6.1             Quality Control.  Hovione will apply its quality control procedures and in-plant quality control checks to the Manufacture of Product for Client, including both Manufacture of Product as part of Development Services and Manufacture of Product as part of Manufacturing Services, in accordance with Applicable Laws and other industry standards.  In addition, Hovione will test and release Product in accordance with the Product Specifications and the Master Batch Documentation.

 

6.2             Batch Records and Deviations.  Upon completion of any Product testing required to be done by Hovione under this Agreement for a Batch, Hovione will make the Batch available to Client in accordance with (i) or (ii) of the first sentence of Section 5.8, and will provide to Client copies of the Batch Records related to such Batch, and the Certificate of Analysis or Bulletin of Analysis, as described in an applicable Work Order, and quality control records containing the raw data from test results related to the Certificate of Analysis or, if requested in advance in writing by Client, make such Batch Records available to Client for review at the Facility.  The date when the Batch and Batch Records and the Certificate of Analysis or Bulletin of Analysis, as described in an applicable Work Order, are delivered or, at Client’s request, otherwise made available to Client, is the “Batch Delivery Date”.  All deviations from the Manufacturing Standards will be investigated and fully documented by Hovione.  Documentation related to any such deviation and investigation will be retained as part of the Batch Records for the Batch affected.  When reasonably deemed necessary, Client reserves the right to request a more in-depth investigation of any deviation by Hovione.  Hovione and Client will work together in determining the need for additional investigational work.  If Client approves of any significant deviation from the Manufacturing Standards, then such approval will be obtained in writing (.pdf electronic document confirmation is acceptable).  At Client’s request, Client and Hovione will jointly provide the documented product impact assessment for all deviations that may impact the Product.

 

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6.3             Quality Assurance.  The Parties will negotiate and approve a quality agreement (“Quality Agreement”) outlining the responsibilities and key contacts for quality and quality-related issues consistent with the terms of this Agreement.  The Parties will use good faith efforts to negotiate and execute the Quality Agreement for Development Services no later than * days after the Effective Date, but in any event prior to commencement of Manufacturing of any cGMP Batches, and the Quality Agreement for Manufacturing Services no later than * days after a Commercial Supply Election.  Matters that may be addressed in the Quality Agreement include, but are not limited to, quality responsibilities related to recalls, complaints, annual Product reviews, returned goods, regulatory audits, and compliance with such other quality-related concerns as are deemed appropriate by the Parties.

 

6.4             Acceptance of Product. Client or Client’s designee will have * days from the Batch Delivery Date to inspect and test samples of the Product, using the testing methods identified in the Product Specifications (unless the Parties mutually agree in writing to any alternative testing methods) and review the Batch Records (the “Inspection Period”), and will give Hovione notice (a “Deficiency Notice”) (i) of any Product that fails to comply with any of warranties of Hovione stated in Section 13.2(a) or that is delivered without a Certificate of Analysis or Bulletin of Analysis, as applicable; (ii) if applicable, of any shortages reconciled against the relevant Purchase Order; and (iii) of any Product that does not comply with the Manufacturing Standards.  Such notice shall specify the nature of the Product’s non-compliance.  In the event Client fails to provide Hovione with a Deficiency Notice for Batch of Product within the Inspection Period, then such Batch of Product will be deemed to have been accepted by Client.  Notwithstanding anything in this Agreement to the contrary, the remedies available to Client under this Section 6 will be extended if Client discovers a latent defect in a Batch of Product within * after the date of delivery of such Batch of Product provided that Client provides a Deficiency Notice to Hovione within * days after Client’s discovery of such latent defect.  Nothing in this Section shall be deemed a limitation on Client’s rights and Hovione’s obligations under Section 14.2.

 

6.5             Determination of Deficiency.  Upon receipt of a Deficiency Notice, Hovione will have * business days from Hovione’s receipt of the Deficiency Notice (the “Response Date”) to advise Client in writing that (a) it disagrees in good faith with the contents of such Deficiency Notice, or (b) that despite using good faith efforts, additional time will be required to assess the Deficiency Notice (either, a “Response Notice”).  In the case of a Response Notice identifying that additional time is required, the Response Notice shall specify how much additional time is reasonably required by Hovione, which shall not be more than * business days unless Hovione specifically identifies issues that cannot be properly addressed within such * period,  and the Response Date will be deemed extended by such period.  If Hovione does not respond to the Deficiency Notice within the Response Date the Deficiency Notice will be deemed accepted by Hovione.  If Client and Hovione fail to agree within * business days after Client’s receipt of a Response Notice from Hovione as to whether the Product satisfies the Manufacturing Standards then the Parties will promptly mutually select an independent laboratory that meets the requirements of cGMP, if Product analysis is required, and an independent Third Party expert with manufacturing expertise, as appropriate, if any other evaluation is required, in either case, of recognized standing in the industry (each such laboratory or expert to be referred to as, an “Independent Expert”), to evaluate a representative sample of Product, using a review of Batch Records and the testing methods described in the Product Specifications, to determine if the Product is nonconforming from the relevant Product Specifications or to otherwise determine whether Product meets the Manufacturing Standards.  Consent to the appointment of such Independent Expert shall not be unreasonably withheld or delayed by either Party.  Such evaluation will be binding on the Parties absent manifest error, and if such evaluation certifies 

 

17

 

that the Product is nonconforming from any Product Specifications or otherwise does not meet the Manufacturing Standards, Client may reject said Product as set forth in Section 6.6.  If such evaluation reveals that the Product in question complies with the Product Specifications and meets the other Manufacturing Standards then Client will be deemed to have accepted delivery of such Product upon the Independent Expert issuing its opinion.  The fees and expenses of the Independent Expert incurred in making such determination shall be paid by the Party against whom the determination is made.

 

6.6             Rejection.

 

(a)                 Subject to Sections 6.4, 6.5, 6.6(b) through 6(e) and 6.7, Client has the right to reject and return, *, any portion of any shipment of Product as to which (i)  Hovione has not sent a Response Notice within * business days from its receipt of a Deficiency Notice; (ii) an Independent Expert engaged under Section 6.5 has found is nonconforming from the Product Specifications or otherwise does not meet the Manufacturing Standards, or (iii) the Parties agree is nonconforming from the Product Specifications or has not been Manufactured in accordance with the Manufacturing Standards, without invalidating any remainder of such shipment.  For clarity, the Deficiency Notice will apply only to those portions of the shipment identified in the Deficiency Notice and the remedies set forth in this Section 6.6 will not apply to any other portions of such shipment.

 

(b)                 In such event, Hovione will, at * cost subject to Sections 6.4, 6.5, 6.6(a), 6.6(c) and 6(e) and 6.7, within * days after receipt of additional Client-Supplied Materials, or as mutually agreed to between the Parties, replace such rejected amounts with Product that conforms with the Product Specifications and has been Manufactured in accordance with the Manufacturing Standards, except that in the case where such nonconforming Product was the result of Hovione’s gross negligence or willful misconduct, then Hovione will, at Client’s election, either, (i) * days after receipt of additional Client-Supplied Materials, replace, at * cost, such rejected amounts with Product that, subject to Section 6.6(e) conforms with the Product Specifications and has been Manufactured in accordance with the Manufacturing Standards, or (ii) refund to Client all amounts paid by Client for such amount of Product within * days of Client’s election of a refund.

 

(c)                 Material Losses/Gains.  In the event there has been any Material Loss or Material Gain in any calendar year during the Term, the following terms will apply:

 

(i)        Prior to Process Validation Completion: Material Loss.  Prior to Process Validation Completion for the Product and subject to the limits set forth in Section 14.4, Hovione will, within * days of the end of each calendar year, issue Client a credit in the amount of the quantity of Materials represented by such Material Loss, but solely to the extent such Material Loss results from Hovione’s gross negligence or willful misconduct or failure to perform Manufacturing activities in accordance with the Master Batch Documentation and cGMP.

 

(ii)       After Process Validation Completion: Material Loss.  Subject to the limits set forth in Section 14.4 and the offset provisions of Section 6.6(c)(iii), after Process Validation Completion, Hovione will, within * days of the end of each calendar year, issue Client a credit in the amount of the quantity of Client-Supplied Materials represented by such Material Loss.

 

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(iii)      After Process Validation Completion: Offset for Material Gain.  After Process Validation Completion, any Material Loss in each calendar year will be offset by *of any Material Gain in such calendar year prior to calculation of the credit to be issued to Client under Section 6.6(c)(ii).

 

(iv)      Report.  For each calendar year during the Term, Hovione will provide Client with a written report showing how the credit was calculated in this Section 6.6(c), including showing the amount of Material Loss and any Material Gain during such calendar year, and describing the nature of any Material Loss and Material Gain, respectively, during such calendar year.

 

(v)       Reimbursement.  Within * days of the termination or expiration of this Agreement, Hovione will pay to Client, or Client will pay to Hovione, as the case may be,  an amount equal to the value of any credits accrued under this Section 6.6(c); provided however, that any amounts that a party is required to pay pursuant to this Section 6.6(c)(v) may be offset against other amounts otherwise owed to such client pursuant to Section 12.4 of this Agreement, as the case may be.

 

(d)           Sole Remedy.  The remedies set forth in this Section 6.6 are Client’s sole remedy under this Agreement with respect to non-conforming Product.  Notwithstanding the foregoing, nothing in this Section shall be deemed a limitation on Hovione’s obligations, or Client’s rights, under Sections 8.11 or 14.2.

 

(e)           Prior to Process Validation Completion: Conformance.  Notwithstanding anything in this Section 6 to the contrary, prior to Process Validation Completion the remedies available to Client under this Section 6 will not apply to Product that fails to conform to the Product Specifications or subsection (ii) of the Manufacturing Standards, unless such failure resulted from Hovione’s negligence or willful misconduct or failure to perform Manufacturing activities in accordance with the Master Batch Documentation and cGMP.

 

6.7             Nonconformity of Client-Supplied Materials.  Notwithstanding anything to the contrary in this Agreement, Product will not be considered to be nonconforming with Product Specifications or the Manufacturing Standards if such failure is a result of a latent defect caused by Client-Supplied Materials.

 

SECTION 7.           PAYMENT TERMS.

 

7.1             Development Fees.  Client will pay for Development Services (including fees and specified pass-through costs) in accordance with the applicable payment terms for such Development Services as specified in the applicable Work Plan (the “Development Fees”), but not to exceed, in the aggregate with respect to any Work Plan, the cap for Development Fees specified in the Work Plan, unless the Work Plan and payment amounts and payment schedule have been amended in writing through a Change Order signed by both Parties in accordance with the terms of Section 2.3.

 

7.2             Supply Price for Manufacturing Services.  Based on the outcome of the Development Services and no later than * days after Process Validation Completion, the Parties will mutually agree in writing on a price per kg of Product (not including the cost of Client-Supplied Materials) for Manufacture of commercial supplies of Product (the “Supply Price”) to apply in the event of a Commercial Supply Election, provided that in no event will the 

 

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negotiated per unit Supply Price exceed *per kg., not including the *, subject to adjustment as set forth in Section 7.3.

 

7.3             Client will pay for Product Manufactured under this Agreement and delivered pursuant to each accepted Purchase Order at the per unit Supply Price agreed upon under the preceding sentence, provided, that, for the sake of clarity, the cost of Manufacture of Product as part of Development Services is included in the Development Fees, and there will not be an additional Supply Price for such Manufacture.

 

7.4             Supply Price Increases.  Not more than *, commencing * delivery of the first Batch of Product ordered after Process Validation Completion, Hovione may increase the Supply Price by *.

 

7.5             Costs Savings. The Parties agree to work together diligently and in good faith to achieve costs savings on both Materials and processes used in the Manufacture of Product (“Costs Savings”).  In the event that the following initial Costs Savings (per kg) amounts (as such amounts may be amended as set forth below, the “Initial Cost Savings Targets”) are achieved, * of the Initial Cost Savings Targets shall benefit *:

 

	
·
    	
Initial Costs Savings Target Related to *
    	
 
    
	
 
    	
(reduction in molar equivalence) is Realized at   Scale:
    	
*
    
	
 
    	
 
    	
 
    
	
·
    	
Initial Costs Savings Target Related to an Alternate   Supplier
    	
 
    
	
 
    	
of * Following the Qualification of Such Alternate   Supplier:
    	
*
    

 

For the avoidance of doubt, * of the actual Cost Savings achieved that are equal to or less than the Initial Cost Savings Targets listed above will benefit *.  In the event the Initial Cost Savings Targets cannot be achieved, the parties will agree to a reduced Initial Cost Savings Target to reflect those amounts actually achieved.  In the event that the total amount of actual Cost Savings exceeds the Initial Costs Savings Targets, the Parties agree * such Costs Savings that exceed the Initial Cost Savings Targets (such Cost Savings that exceed the Initial Cost Savings Target being referred to as the “Excess Cost Savings”). The following example is an application of the foregoing Cost Savings principles:

 

	
·
    	
 
    	
 
    

 

*

 

7.6             Invoices.  Hovione will send Client an invoice according to the invoice schedule outlined in the applicable Work Plan for Development Services, or in accordance with Section 5.11 for Manufacturing Services, as applicable.  Payment on undisputed invoices will be due * days after receipt of the applicable invoice by Client.  In the event any undisputed payment is not made on time, Hovione will be entitled, in addition to its other rights and remedies to assess a late fee on any undisputed amounts not paid when due, on a pro rata basis, at a rate of *.   All payments due under this Agreement will be paid in U.S. Dollars by wire transfer of immediately available funds to the following bank account:

 

HSBC Bank (through correspondent bank, HSBC Bank USA)

Bowery Street

New York, NY 10012

For the Account of Hovione International Ltd.,

Account *

 

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7.7             Audit.  For a period of *, Client will have the right to conduct an audit of Hovione’s records with respect to (i) Hovione’s costs for any Supply Price increases imposed by Hovione under Section 7.3; (ii) any pass-through costs paid as part of Development Fees; and (iii) any Material Loss and Material Gains under Section 6.6(c).  In the event any audit shows that a Supply Price increase paid by Client in any year exceeded the permitted Supply Price increase under Section 7.3 or Client overpaid Development Fees or Hovione underpaid any amount due Client or underpayment Client of any amounts due Hovione under Section 6.6(c) then Hovione will credit the overpayment or underpayment by Client or the underpayment or overpayment by Hovione to the next invoice issued to Client immediately following written notice of the results of such audit.  * shall bear the costs and fees associated with any audit conducted under this Section 7.5; provided, however, that if such audit demonstrates that *, then the costs and fees associated with the audit shall be paid by *.

 

7.8             Taxes.  Except as expressly set forth in the Work Plan, all fees are exclusive of value-added taxes.  If Client is required by law to pay or withhold any income or other taxes on behalf of Hovione with respect to amounts paid to Hovione under this Agreement; (i) Client shall deduct such taxes from the amounts paid to Hovione; (ii) any such tax required to be paid or withheld shall be an expense of and borne solely by Hovione; and (iii) Client shall promptly provide Hovione with a certificate or other documentary evidence to enable Hovione to support a claim for a refund or foreign tax credit. Notwithstanding the foregoing, Client shall be solely responsible for any taxes including, but not limited to value-added tax or importation duties, related to Client-Supplied Materials.

 

SECTION 8.           COMPLIANCE AND REGULATORY MATTERS.

 

8.1             Compliance with Manufacturing Standards.  Except for those Batches specifically specified as non-cGMP Batches in the Work Plan and subject to Section 6.6(e), all Product delivered to Client under this Agreement will meet the Manufacturing Standards.

 

8.2             Modification of Product Specifications.  Prior to Process Validation Completion, any changes to the Product Specifications will be reviewed and approved in writing by both Parties and, to the extent the change affects the fees set forth in a Work Plan, will be documented in a Change Order or a new or amended Work Plan by the Parties.  After Process Validation Completion, Hovione will implement any modification, material or otherwise, to any Product Specifications as requested by Client or a Regulatory Authority (but under no circumstances without the consent of Client), subject to agreement by the Parties on a Change Order or a new or amended Work Plan or amendment to the Supply Price, as applicable, if such change will affect the fees set forth in a Work Plan or the costs used in the calculation of Supply Price under Section 7.2.  If such modification results in the requirement to reprocess and/or retest previously Manufactured and otherwise acceptable Product, any additional costs incurred by Hovione in such reprocessing and/or retesting will be paid by * within * days after Client’s receipt of the final report of the results of the retest or reprocessing or as otherwise set forth in the relevant Work Plan.  If any modification to any Product Specifications is requested by a Regulatory Authority, but not agreed to by Client and the failure of Client to provide such consent cannot otherwise be resolved as between Client and Hovione, the matter shall be resolved pursuant to Section 18; provided however; nothing contained herein shall prevent Hovione from taking any and all actions it reasonably believes are required to comply with all Applicable Laws and all obligations imposed by any Regulatory Authority.

 

8.3             Modification of Product Process.  Hovione will make changes to the Manufacturing Process or the Master Batch Documentation or other Manufacturing Documents 

 

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as requested by Client or a Regulatory Authority, subject to agreement by the Parties on a Change Order or a new or amended Work Plan or amendment to the Supply Price, as applicable, if such change will affect the fees set forth in a Work Plan or the costs used in the calculation of Supply Price under Section 7.2, but will not otherwise make any such change with respect to the Manufacture of the Product without the prior written approval of Client. Client will be responsible for obtaining all necessary regulatory approvals from Regulatory Authorities, if any are required, in connection with any proposed change to the Manufacturing Process.

 

8.4             Changes to Facility.  Hovione will not use any facility in the Manufacture of Product other than the Facilities.  Hovione will not make any change at the Facility that would result in a change of the Manufacturing Process or may affect the identity, quality, purity, potency or bioavailability of Product or that would otherwise require prior approval of any applicable Regulatory Authority without giving Client at least * days’ prior written notice of such change and making available to Client all information required for applicable Regulatory Authority approval.  Hovione will notify Client, in writing, of all other changes to the Facilities as required by Applicable Law.

 

8.5             Environmental Compliance.  The generation, collection, storage, handling, transportation, movement and release of hazardous materials and waste generated by or on behalf of Hovione in connection with the Manufacture of Product and other Services under this Agreement will be the responsibility of Hovione, at the cost and expense of Hovione.  Without limiting other legally applicable requirements, Hovione will prepare, execute, and maintain as the generator of waste, all licenses, registrations, approvals, authorizations, notices, shipping documents and waste manifests required under Applicable Laws.  Client will provide Hovione the information set forth in Section 3.4.

 

8.6             Audit by Client.  Upon at least * business days’ prior written notice, and, subject to the next sentence, no more than * per Facility, Hovione will permit two (2) (or such other number of persons agreed to by Hovione) Client representatives (which may include representatives of Client’s Affiliates and any of their respective consultants, but will not include representatives who are competitors of Hovione) who are subject to confidentiality obligations no less stringent than the confidentiality obligations set forth in this Agreement, to conduct, during normal business hours during the Term, quality assurance audits and inspections of Hovione’s Records and the Facilities related to Development Services or Manufacturing Services solely to ascertain compliance by Hovione with the terms of this Agreement in the performance of the Services.  Notwithstanding the foregoing, (i) the vendor selection audit performed on the 12th and 13th of May, 2011 by Client or Client’s representatives to qualify Hovione as a vendor does not qualify as an * audit and (ii) any vendor selection audit to qualify Hovione to perform additional Services other than the Services included in the Work Plan that is attached as Appendix D, and preparatory audits conducted in preparation for an approval inspection by a Regulatory Authority may be conducted in addition to the foregoing * audit; and (iii) Client may, upon * business days’ written notice, conduct additional audits in the event any audit conducted by Client or an audit by a Regulatory Authority reveals a material compliance deficiency.  All information disclosed or ascertained by Client in connection with any audit or inspection that is not Confidential Information of Client will be deemed to constitute Confidential Information of Hovione, subject to the terms of Section 11.  Except as expressly set forth in the Work Plan, the costs of Hovione personnel participating in any audit under this Section will be borne by *.

 

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8.7             Regulatory Authority Inspections. Hovione will be responsible for inspections of its Facilities by any Regulatory Authorities, and will, to the extent permitted by Applicable Law, within * business days of receipt of notice from a Regulatory Authority, notify Client if such inspections are directly related to the Manufacture of Product or if the results of a non-related inspection could reasonably be expected to impair the ability of Hovione to perform in accordance with this Agreement.  With respect to inspections solely related to the Product, Hovione will, to the extent permitted by Applicable Law, (i) provide Client with copies of all documents, reports or communications received from or given to any Regulatory Authority associated therewith; (ii) permit Client’s representatives to be present on site and participate, as appropriate, based on questions or requests specific to Client or Product, and as permitted by Regulatory Authorities, in such inspections and participate in the wrap-up sessions; and (iii) allow Client the opportunity to review and provide comments to Hovione with respect to matters related to the Product, and Hovione will draft any such correspondence to Regulatory Authorities taking into account Client’s comments.

 

8.8             Cure of Deficiencies.  Hovione will be responsible for correcting any deficiencies identified in any inspection of the Facilities conducted by any Regulatory Authority from the U.S, the European Union or Japan or by any other Regulatory Authority if the deficiency is a failure to comply under Applicable Law under this Agreement, at the cost of Hovione.  In addition, following any audit provided for in Section 8.6, Client will discuss its observations and conclusions with Hovione and any corrective actions will be discussed by the Parties. If Hovione agrees that an item identified by Client is a deficiency (such agreement not to be unreasonably withheld, conditioned or delayed) for which Hovione is responsible, Hovione will correct such deficiency, at the sole cost of *.

 

8.9             Interactions with Regulatory Authorities.  Except as set forth in Section 8.7 or for approvals and licenses required with respect to the Facilities which will be the responsibility of Hovione and, except for any portion of the CMC Documentation to be prepared by Hovione as part of Development Services, Client will be responsible for the preparation and filing of Regulatory Filings, if any, and for all contacts and communications with any Regulatory Authorities with respect to matters specifically relating to Product, and Hovione will have no such contact or communication with any Regulatory Authority without the prior written consent of Client.  Hovione will notify Client promptly (and in no event later than *) after Hovione receives any communication from any Regulatory Authority related in any way to the Development Services or Manufacturing Services of Product.  Hovione will provide Client with copies of any such correspondence or other communication within * of receipt of such communication by Hovione.  Hovione will use commercially reasonable efforts to consult with Client regarding the response to any inquiry or observation from any Regulatory Authority relating to Product and, except with respect to matters related to the Facilities, will allow Client, at its discretion, to participate in any further contacts or communications relating to Product.  Hovione will comply with all reasonable requests and comments by Client with respect to all contacts and communications with any Regulatory Authority relating in any way to the Development Services or the Manufacturing Services provided however, that such participation will not prohibit Hovione from responding directly to any Regulatory Authority as required by Applicable Law.  Hovione will provide Client with drafts of any correspondence or other reports to be submitted to Regulatory Authorities concerning the Development Services or the Manufacturing Services for review prior to submission, will consider in good faith Client’s comments, and will provide final copies to Client promptly after submission.  All documents provided to Client under this Section 8.9 may be redacted to remove confidential information of Third Parties.

 

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8.10           Product Complaints.  If Hovione becomes aware that any of the Products Manufactured under this Agreement, whether as part of Development Services or Manufacturing Services, are or may become harmful to persons or property, or that any such Product has become adulterated, contaminated or misbranded, or that the design or manufacture of the Products is defective in any manner which is or may be in violation of Applicable Laws, Hovione shall promptly give written notice to Client, including all relevant information with respect thereto.  Without limiting the generality of the foregoing, Hovione will give Client written notice of any report of a medical or non-medical complaint related to Product Manufactured by Hovione.  Client will be responsible for customer response communications and communications to patients and physicians, to the extent applicable, and reports to Regulatory Authorities.  If any such complaint or report relates to a death or injury following administration of Product or otherwise relates to Product quality, purity, safety or effectiveness, Hovione will notify Client in writing of such complaint or report within *.  All other notices of a complaint or report will be provided to Client within * business days. If Client receives, or reasonably determines that a complaint or report on the Product relates to Product quality, purity, the Manufacturing Standards, or the Facility, Client will notify Hovione promptly in writing of such complaint or report but in any event no more than within *  business days.  Hovione will cooperate by conducting any investigation related to Manufacturing of Product related to any such complaint as Client may reasonably request.  Additional processes related to handling and reporting of complaints will be set forth in the Quality Agreement.

 

8.11           Recalls.  Product recalls will be the responsibility of, and under the control of, Client.  In the event that Hovione has reason to believe that any Product should be recalled or withdrawn from distribution, it will promptly inform Client in writing of such belief.  Client will notify the appropriate Regulatory Authorities of any recall, if required under Applicable Law, and will be responsible for coordinating all necessary activities regarding the action taken.  Hovione and Client will fully cooperate to complete the recall, and will thereafter resolve any allocation of liability as may be appropriate in accordance with the terms of this Agreement.  The costs and expenses of conducting any recall will be treated as follows:

 

(a)                 If any Product is recalled as a result of Hovione’s negligence or willful misconduct in Manufacture of the Product or failure to Manufacture Product in accordance with the Manufacturing Standards then, except to the extent the recall resulted from any failure of Client-Supplied Materials unless Hovione knew of, or should have known of a failure of the Client Supplied Materials to conform to the applicable Material Specifications, as a result the testing of Client-Supplied Materials the parties had mutually agreed in writing would be performed by Hovione as part of Services, *.  In addition, in such event, Hovione, *, will promptly replace such rejected and recalled amounts with Product that conforms to the Product Specifications and is Manufactured in accordance with the Manufacturing Standards and shall reimburse Client for Material Loss in accordance with Section 6.6. Hovione’s total liability to Client under this Section 8.11 for each particular recall, market withdrawal or correction shall not exceed the aggregate Manufacturing Fees, if any, paid by Client to Hovione for the total amount of Product that is contained in the drug product that is recalled, withdrawn from the market or corrected. In addition, the limitations set forth in Section 14.4  hereof shall also apply to any liability of Hovione under this Section 8.11.

 

(b)                 If each Party contributes to the cause for a recall, the amounts contemplated under paragraph (a) will be *; and

 

(c)                 All recalls of Product supplied to Client under this Agreement other than those described in clauses (a) or (b) will be at * sole expense.

 

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Client will give Hovione prompt written notice of any Product recalls for which Client believes Hovione has responsibility under Section 8.11(a) or (b).

 

8.12           Information.  Hovione will supply to Client, for use by Client and its Affiliates and their respective licensees or sublicensees and contractors who are subject to written obligations of non-use and confidentiality with Client at least as stringent as those obligations set forth in this Agreement, such data and information related to Development Services and Manufacturing Services as Client may, from time to time reasonably request, including, but not limited to, information in support of filings, if any, with Regulatory Authorities or in response to questions from Regulatory Authorities, concerning the Development Services or the Manufacture of Product.

 

8.13           Client Employees On-Site.  During the Term of this Agreement, Client will have the right to have up to * on site to observe Development Services and Manufacturing Services during Client’s normal business hours of 8 A.M. to 5 P.M. local time in the location at which the Development Services or Manufacturing Services are being performed or at such other reasonable time(s) as Hovione may agree to upon the request of Client, such agreement not to be unreasonably withheld, conditioned or delayed by Hovione.  Client agrees to require each of its employees on site to comply with posted policies or other written policies of Hovione of which Client is made aware, in each case to the extent such policies are in compliance with Applicable Laws.

 

8.14           Records and Retained Samples.  Hovione will maintain all materials, data and documentation obtained or generated by Hovione in the course of performing the Development Services or Manufacturing Services under this Agreement, including all reference standards, retained samples of Product and key intermediates, and computerized records and files (the “Records”) in a secure area reasonably protected from fire theft and destruction for the longer of (i) * after completion of the applicable Work Plan under which such Records were generated or (ii) * past the last expiration date of Product supplied under this Agreement, or, in each case, such longer period as is required by Applicable Law (the “Retention Period”).  At the end of the Retention Period, all Records will, at Client’s option, either be (a) delivered to Client or to its designee in such form as is then currently in the possession of Hovione, (b) retained by Hovione, *, until further disposition instructions are received or (c) disposed of, at the direction and written request of Client.  In no event will Hovione dispose of any Records without first giving Client at least * days’ prior written notice of its intent to do so and an opportunity to have the Records transferred to Client.  While in the possession and control of Hovione, Records will be available during audits or at other mutually agreed to times for inspection, examination, review or copying by Client and its representatives; provided, however, that Hovione may exclude or redact from such Records any confidential or proprietary information of Third Parties.  Notwithstanding anything in this Section to the contrary, Hovione may retain copies of any Records as necessary to comply with Applicable Law, regulatory requirements or its obligations under this Agreement, subject to the obligations of confidentiality of Hovione under this Agreement.

 

8.15           Other Notices.  Hovione will notify Client within * business days (or such shorter period as may be required by applicable law) of becoming aware of (i) any error or mistake in the Batch Records with respect to Product; and (ii) any other event that might reasonably be expected to have an adverse effect on Hovione’s ability to meet its obligations under this Agreement with respect to Services.  The foregoing notices shall not relieve Hovione of any liability hereunder associated with the subject of such notices.

 

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SECTION 9.           INTELLECTUAL PROPERTY.

 

9.1             Existing Proprietary Information.  All rights to and interest in Hovione Background Intellectual Property and Confidential Information of Hovione will remain the exclusive property of Hovione, subject to the license granted to Client under Section 10.3, and all rights to and interest in Client Background Intellectual Property and Confidential Information of Client will remain the exclusive property of Client subject to the license granted to Hovione under Section 9.2(b).

 

9.2             Client Intellectual Property.

 

(a)                 Assignment of Product-Related Intellectual Property.  Hovione hereby assigns to Client all of the right, title and interest of Hovione in and to the Product-Related Improvements.  Hovione agrees to assist Client in securing for Client any patents, copyrights or other proprietary rights in Product-Related Know-How, and agrees to take such actions and execute such documents as Client may reasonably request in connection with providing such assistance or otherwise to vest in Client all right, title and interest in Product-Related Improvements.  Hovione will be compensated for all of its reasonable out-of-pocket costs and expenses associated with such requested assistance.  To the extent Product-Related Improvements cannot be assigned to Client under this Section, Hovione grants to Client and its Affiliates an exclusive perpetual, irrevocable, transferable, fully paid-up, worldwide license, with the right to grant sublicenses, under such Product-Related Improvements for any and all purposes.

 

(b)                 License Grant.  Client hereby grants to Hovione a worldwide, nonexclusive, fully paid-up license, without the right to grant sublicenses except to subcontractors specifically approved by Client under Section 16(b), to any Client Background Intellectual Property and Product-Related Improvements solely for use in Manufacturing of Product for Client under this Agreement.

 

9.3             Hovione Improvements.  Hovione will remain the owner of all of its rights to and interest in Hovione Improvements, subject to the rights and licenses granted to Client and its Affiliates under Section 10.3 provided in any case, that Hovione will not use any Hovione Improvements in violation of Section 2.7.

 

9.4             Patents.  Client will have the exclusive right to prepare, file, prosecute, maintain and defend, at * expense, any patent applications and/or patents that claim Product-Related Improvements.  Hovione will have the exclusive right to prepare, file, prosecute, maintain and defend, at * expense, any patent applications and/or patents that claim Hovione Improvements.

 

9.5             Development Deliverables.  Client will own the Development Deliverables except for any Proprietary Formats and other Confidential Information of Hovione contained in such Development Deliverables.  Client will have the right to transfer the Development Deliverables to one or more Third Parties, including Confidential Information of Hovione contained in such Development Deliverables, provided that such Third Parties, other than Regulatory Authorities, are subject to confidentiality and non-use terms with respect to Confidential Information of Hovione no less restrictive than those set forth in this Agreement, and provided further that, to the extent feasible and reasonably practical, Client uses good faith efforts to remove the Proprietary Formats that do not fall under the exceptions set forth in Section 11.2 prior to transferring the Development Deliverables to such Third Party other than Regulatory Authorities unless Hovione otherwise agrees in writing.  Notwithstanding anything 

 

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in this Agreement to the contrary, Client will not be required to remove Proprietary Formats prior to transferring the Development Deliverables to an Affiliate of Client or to a consultant of Client providing quality assurance/quality control services pertaining to this Agreement to Client or providing regulatory support services with respect to Product as long as such Affiliate or consultant is bound by obligations of confidentiality and restrictions on use at least as stringent as those set forth in this Agreement.  For the sake of clarity, and not in limitation of any term of this Agreement, Hovione will not have the right to use the Development Deliverables or Product-Related Improvements for any purpose other than performance of the Development Services or Manufacturing Services for Client and its Affiliates under this Agreement.  For clarity, nothing herein is intended to limit Hovione’s right to use the Proprietary Formats and other Confidential Information of Hovione contained in the Development Deliverables.

 

9.6             Third Party Technology.  Hovione will not knowingly utilize in the performance of the Development Services or in the Manufacture of Product under this Agreement or incorporate into the Manufacturing Process or any Development Deliverables any technology or materials covered by proprietary rights of a Third Party except as Hovione is freely permitted to do without further compensation by Client to Hovione or to any Third Party.

 

SECTION 10.             TECHNOLOGY TRANSFER AND LICENSE GRANT

 

10.1           Internal Technology Transfer.  Notwithstanding anything in this Agreement to the contrary, internal technology transfer activities conducted by Hovione within the Facilities will be the * responsibility of * of the final technology transfer plan and of the technology transfer data package that establishes that the activities have been successfully transferred.  For sake of clarification, internal technology transfer activities do not include production of any registration and/or validation batches required to qualify another facility to the extent such activities are set forth in a mutually agreed upon Work Plan.

 

10.2           Technology Transfer to Third Party.

 

(a)                 General.  Hovione will, at Client’s request upon the occurrence of (b)(i), (b)(ii) or (b)(iii) below and subject to the applicable terms set forth in such subsections, cooperate with Client in the transfer of the Manufacturing Process and Master Batch Documentation to one (1) Third Party designated by Client by providing such technical assistance and documentation as Client may reasonably request (a “Technology Transfer”).

 

(b)                 Technology Transfer Terms.

 

(i)        Because of Termination by Hovione.  In the event of termination of this Agreement by Hovione under Section 12.2(d), Client may exercise its right to Technology Transfer, but must exercise its right to a Technology Transfer within * after notice of termination by Hovione pursuant to Section 12.2(d).  Any Technology Transfer under this subsection (i) will be provided by Hovione * to Client.

 

(ii)       Because of Supply Failure.  Upon the occurrence of a Supply Failure  or in the event of termination of this Agreement by Client under Section 12.3(a), (b) or (c), Client may exercise its right to a Technology Transfer provided that in the case of a Supply Failure, if Client fails to exercise Client’s right to a Technology Transfer prior to Hovione remedying such Supply Failure, then such right due to a Supply Failure will be suspended until such time, if 

 

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ever, that another Supply Failure occurs.  Any Technology Transfer under this subsection (ii) will be provided by Hovione at no charge to Client.

 

(iii)          Qualification of Second Supplier.  Subject to the terms of this Agreement, Hovione recognizes that Client may wish to use an additional manufacturer to Manufacture or process Product in order to, among other reasons, reduce or spread Client’s business risk and Hovione agrees, at Client’s request, to provide a Technology Transfer to such additional manufacturer.  All Technology Transfer costs billed by Hovione pursuant to this subsection (iii) shall be paid *.

 

(iv)          No Limitation on Use of Development Deliverables.  For the sake of clarity, this Section 10.2 is not intended to be a limitation of Client’s rights under Sections 9.5 or 10.3 and, without being considered Technology Transfer under this Section 10.2, Hovione will make available the Manufacturing Documents and other Development Deliverables to Client, at Client’s request.

 

10.3           License Grant to Client.  Subject to Sections 11.3 and 9.5, Hovione hereby grants to Client an irrevocable (with respect to Product), worldwide, nonexclusive, fully paid-up license, with the right to grant sublicenses, to any Hovione Background Know-How and Hovione Improvements which have been incorporated into the Manufacturing Process or into any Development Deliverable (including, subject to Section 9.5, any Proprietary Formats) and under any corresponding Hovione Background Patent Rights and under Hovione’s intellectual property rights covering Hovione Improvements, in each case, solely for use in manufacturing of Product whether by Client or any of its Affiliates, or any of their respective licensees or sublicensees or by a Third Party for the benefit of Client or any of its Affiliates or any of their respective licensees or sublicenses solely for use in manufacturing of Product.

 

10.4           Requirements for Sublicenses.  Client shall be solely responsible for the actions of any Third Party or Affiliate of Client to which Client sublicenses its rights under Section 10.3.  Client shall cause any such sublicensee to be bound by, and to comply with, (i) the limitations on Client’s rights granted in Section 10.3, and (ii) confidentiality requirements relating to the Hovione Background Know-How, Hovione Improvements and other Hovione Confidential Information that are no less strict than those applicable to Client under this Agreement.

 

SECTION 11.             CONFIDENTIAL INFORMATION.

 

11.1           Obligation.  A Party (the “Receiving Party”) receiving or in the possession of Confidential Information of the other Party (the “Disclosing Party”) will not, without the prior written consent of the Disclosing Party, (i) use the Disclosing Party’s Confidential Information except for purposes of fulfilling the Receiving Party’s obligations or exercising its rights under this Agreement or as otherwise expressly permitted under this Agreement, or (ii) disclose the Disclosing Party’s Confidential Information to any Third Party, except as otherwise expressly permitted under this Agreement.  The Receiving Party may disclose Confidential Information of the other Party to those employees, directors, representatives, advisors, consultants, service providers, or agents of the Receiving Party who have a specific need to know such information for permitted uses under this Agreement and who are subject to restrictions on use and nondisclosure obligations at least as stringent as those obligations set forth in this Agreement.  The obligations of each Party under this Section 11 relating to the other Party’s Confidential Information will expire * after expiration or termination of this Agreement, except that with respect to any Confidential Information comprising a trade secret of the Receiving Party, the

 

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obligations of the Receiving Party under this Section with respect to such Confidential Information will continue until the information becomes the subject of one of the exceptions set forth in Section 11.2.  The disclosure of Confidential Information by the Disclosing Party under this Agreement does not constitute the grant of any license or any other rights, or generate any business arrangements, unless specifically set forth herein or in another writing.  The Disclosing Party will, at the time of disclosure, label all trade secrets as such at the time of disclosure.

 

11.2           Exceptions.  Notwithstanding the foregoing, the obligations of confidentiality and nonuse under this Section 11 will not apply to, information of a Disclosing Party if such information:

 

(a)       is already known to the Receiving Party prior to receipt or being generated under, or related to this Agreement, as evidenced by the Receiving Party’s written records and without obligation of confidentiality;

 

(b)       is disclosed to the Receiving Party without restriction after the Effective Date by a Third Party who has the right to make such disclosure on a non-confidential basis and is not providing such information on behalf of the Disclosing Party;

 

(c)       is independently developed by or for the Receiving Party other than in connection with this Agreement without use of, reference to, or reliance on the Confidential Information of the Disclosing Party as evidenced by the Receiving Party’s written records; or

 

(d)       becomes available to the general public without fault of the Receiving Party.

 

  In addition, notwithstanding anything in this Agreement to the contrary, the Receiving Party will be entitled to disclose Confidential Information of the Disclosing Party to the extent such disclosure is required by applicable law or pursuant to a subpoena or other court order of a proper authority, provided that, to the extent permitted by applicable law, the Receiving Party gives the Disclosing Party prompt written notice of such requirement prior to such disclosure and provides assistance to the Disclosing Party, at the reasonable request and expense, of the Disclosing Party in limiting the scope of the information to be provided or in obtaining an order protecting the information from public disclosure.

 

11.3           Other Permitted Disclosures and Use.  Notwithstanding anything in this Agreement to the contrary,  Client and its Affiliates, licensees and sublicensees may use Confidential Information of Hovione in connection with Regulatory Filings related to Product or for any other purposes that are consistent with the rights or licenses granted to Client under Section 9 and Section 10.3, including, but not limited to, using any Confidential Information of Hovione incorporated into the Development Deliverables (including, subject to Section 9.5, any Proprietary Formats) for the purpose of manufacturing Product or having Product manufactured for Client or any of its Affiliates, licensees or sublicensees by a Third Party, to the extent consistent with the terms of this Agreement.  To the extent consistent with the foregoing sentence, Client may disclose Confidential Information of Hovione (i) to any Regulatory Authority or other governmental authority and (ii) to any Affiliate of Client or to any licensee or sublicense or other Third Party who is manufacturing Product or providing related services to Client or any of its Affiliates, licensees or sublicensees, provided each such Third Party other than a Regulatory Authority is under an obligation of confidentiality and restrictions on use with respect to such information that are at least as restrictive as those applicable to Client under this Section.

 

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11.4           Terms of Agreement.  The terms and conditions of this Agreement are the Confidential Information of both Parties.  Neither Party will disclose the existence of this Agreement or any terms and conditions of this Agreement except (a) with the other Party’s prior written consent; (b) as required to comply with foreign, federal, state or local laws and regulations (including, without limitation, federal and state securities laws and regulations or listing requirements of any stock exchange or market); (c) to advisors, investors and potential investors and potential acquirers and, in the case of Client, to existing or potential collaborators, licensees and Third Party consultants and service providers, in each case on a need-to-know basis under circumstances that ensure confidentiality; or (d) in a public announcement permitted under Section 20.6.  Notwithstanding the foregoing, Client may publicly identify Hovione as one of its contract manufacturers and as the source of Product supplied under this Agreement.

 

11.5           Remedies.  Each Party acknowledges that the remedy at law for any breach of this Section 11 may be inadequate, and the full amount of damages that may result from such breach may not readily susceptible to being measured in monetary terms.  Accordingly, in the event of a breach or threatened breach by either Party of this Section 11, the other Party will be entitled to seek immediate injunctive relief and specific performance.  Such remedies will be in addition to any other remedies that may be available in law or equity.

 

SECTION 12.             TERM AND TERMINATION

 

12.1           Term.  This Agreement will become effective as of the Effective Date, and unless earlier terminated under this Section 12, will continue in effect for * from the last to occur of (i) the completion of all Development Services under the last Work Plan executed by the Parties prior to the * of the Effective Date, or (ii) Launch Date of the Product in the first to occur of Europe, Japan or the United States subject in each of (i) and (ii) to extension by signed, written agreement of both Parties (the “Term”).

 

12.2           Voluntary Termination Right.

 

(a)                 Development Work.  Client, will have the right to terminate this Agreement, in its entirety, after each phase of the initial Work Plan attached to this Agreement as Appendix D, *.  For the avoidance of doubt, Hovione’s final invoice for each phase of the Initial Work Plan shall serve as written notification to Client of the completion of that phase of the Initial Work Plan.  In the event Client does not provide written notice of termination within * days’ of completion of a given phase of such initial Work Plan (following receipt of Hovione’s notice), Client will not have a further right of termination under this paragraph (a) until completion of the next phase of such initial Work Plan.  In addition, Client may terminate any Work Plan for Development Services executed after the initial Work Plan upon at least * days’ prior written notice to Hovione without terminating the entire Agreement.

 

(b)                 Termination of the Product.  In the event Client provides Hovione with written notice that Client suspends the development or commercial sale (if such suspension is following approval by a Regulatory Authority to market and sell the Product) of the Product and Client does not recommence the development or commercial sale of the Product for a period of * consecutive months following the date of such notice, then, following the expiration of such * month period, both Client and Hovione will each have the right, but not the obligation, to terminate this Agreement.

 

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(c)                                  Process Validation Completion.  Client will have the right to terminate this Agreement within * days of Process Validation Completion or in the event Process Validation Completion does not occur by * (or any such later date as may be mutually agreed upon by the Parties in writing), within * days thereof; provided that, the basis for such Process Validation Completion having not occurred by such date was due to reasons other than Client’s material breach of this Agreement.

 

(d)                                 After Commercial Supply Election.  If, after occurrence of the Commercial Supply Election, either Party is dissatisfied with the other Party’s performance under this Agreement, the dissatisfied Party must provide the other Party with written notice identifying the specific issues and problems with which the dissatisfied Party is dissatisfied (the “Deficiency Notice”) and, acting in good faith, the Parties will attempt to resolve the issues and problems according to the dispute resolution provisions set forth in Section 18.2. If, despite working together in good faith, the Parties cannot sufficiently resolve the problems or issues set forth in the Deficiency Notice through the dispute resolution process set forth in Section 18.2, the dissatisfied Party may, subject to Section 12.4, terminate this Agreement upon at least * months’ prior written notice to the other Party.

 

12.3               Other Termination Rights.

 

(a)                                  For Breach.  Either Party may terminate this Agreement or any Work Plan by giving the other Party * days’ prior written notice upon the material breach of any provision of this Agreement by such other Party if the breach is not remedied prior to the expiration of such period, except that with respect to a breach of payment obligations, the preceding period shall be limited to * days, provided that the notice of breach of the payment obligation references the termination right set forth in this Section.

 

(b)                                 Due to Force Majeure.  Either Party shall have the right to terminate this Agreement or any active Work Plan(s) by written notice to the other Party upon the occurrence of a Force Majeure Event preventing the other Party from performing its obligations hereunder as provided in Section 19 for * days or more; provided, however, that the right to terminate under this clause shall be limited to the Work Plan(s) affected.

 

(c)                                  For Bankruptcy.  Either Party shall have the right to terminate this Agreement or any active Work Plan by written notice to the other Party if the other Party ceases for any reason to carry on business, or becomes bankrupt or insolvent, makes an assignment for the benefit of its creditors or has a receiver or manager appointed in respect of all or any part of its assets (which appointment will not be vacated within * days after filing) or is the subject of any proposal for a voluntary arrangement or enters into liquidation.

 

12.4               Actions on Termination.

 

(a)                                  Confidential Information and Records.  Upon termination of this Agreement for any reason, each Party will deliver to the other, or destroy at the Disclosing Party’s election, all materials, reports, and other documents (including copies thereof) in its possession or control containing Confidential Information of the other Party, and each will cease to make use  of the other Party’s Confidential Information, except that (i) Client will have no obligation to return or destroy or to cease to make use of any information that Client has a continuing license to use under this Agreement or that is incorporated into Master Batch Documentation, Batch Records or other Manufacturing Documents or that is included in any regulatory filing and (ii)

 

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neither Party will be obligated to return or destroy automatically generated copies stored on system back-up media.

 

(b)                                 Other Obligations on Termination.  Upon termination of this Agreement or any Work Plan(s) pursuant to this Section 12 Hovione shall suspend work at the earliest possible point and, with respect to each terminated Work Plan shall: (i) perform only those Services and activities mutually agreed upon by Client and Hovione as being necessary or advisable in connection with the close-out of the relevant Work Plan; (ii) use commercially reasonable efforts to cancel any Third Party obligations; (iii) promptly deliver to Client all materials ordered by Hovione for Customer, all Development Deliverables and all Product (including any work in process) after receipt of payment in full by Customer of the amount referenced in the next sentence for such materials, Development Deliverables not yet delivered and Product; and (iv) promptly return to Client all Client-Supplied Materials.  Upon termination of this Agreement or any Work Plan(s) pursuant to this Section 12, Client shall, with respect to each terminated Work Plan pay Hovione any monies due and owing Hovione, up to the time of termination, for Services actually performed, and all expenses reimbursable in a Work Plan or a Change Order actually incurred and any reimbursable commitments made by Hovione in connection with such Work Plan or Change Order that are not cancelable.

 

12.5               Survival Provisions.  Termination, expiration, cancellation or abandonment of this Agreement through any means and for any reason will not relieve the Parties of any obligation accruing prior thereto, including, but not limited to, the obligation to pay money, and will be without prejudice to the rights and remedies of either Party with respect to the antecedent breach of any of the provisions of this Agreement.  Further, Sections 1, 2.5 with respect to any final report covering Services performed prior to such termination, 2.7, 4.1(b) and (c), 6.6, 7.5, 8.5, 8.6, 8.9 through 8.11, 8.12, 8.14, 9, 10.2, 10.3, 10.4, 11, 12 14, and 17 through 20, and the last sentence of Section 5.4 (regarding binding commitments) will survive expiration or termination of this Agreement.

 

SECTION 13.                          REPRESENTATIONS AND WARRANTIES.

 

13.1               Client Representations and Warranties.  Client represents and warrants that (i) it owns or controls all of the rights in and to the Client Background Patent Rights, Client Background Know-How, and Confidential Information provided by Client to Hovione; (ii) to the best of Client’s knowledge, the use of the foregoing as contemplated in the Services shall not infringe or misappropriate the intellectual property or other proprietary rights of any Third Party and Client shall promptly notify Hovione in writing should it become aware of any claims asserting such infringement; (iii) Client shall comply with all Applicable Law in its holding, use and disposal of the Product and the Development Deliverables; and (iv) at the time of delivery to Hovione, all Client-Supplied Materials will conform to all applicable Material Specifications, cGMP to the extent applicable and all other Applicable Laws and shall not be adulterated, contaminated or misbranded at the time of delivery to Hovione.

 

13.2               Hovione Representations and Warranties.

 

(a)                                  Hovione represents and warrants: (i) that in performing its obligations under this Agreement it will comply with Applicable Laws; (ii) the Product was Manufactured in accordance with the Manufacturing Standards, ((iii) the Product will be prepared for shipment in accordance with the Shipping Instructions; and (iv) the Product, as delivered, will not be adulterated, contaminated or misbranded.

 

32

 

(b)                                 Hovione represents and covenants that it has not been debarred, and has not been threatened with debarment, nor have any of its employees been debarred or threatened with debarment, in each case, under Section 306(a) or (b) of the U.S. Generic Drug Enforcement Act of 1992, as amended, and Hovione will not knowingly use in any capacity under this Agreement any debarred person or entity.

 

(c)                                  Hovione represents and warrants that, to the best of its knowledge, the use of Hovione Background Intellectual Property in the performance of the Services will not infringe or misappropriate any patent, trade secret or other proprietary or intellectual property right of any Third Party, and that at the time of its execution of this Agreement there is no threatened litigation with respect to any of the foregoing and Hovione shall promptly notify Client should it become aware of any claims alleging such infringement or misappropriation of any Third Party.

 

(d)                                 Hovione shall notify Client within * business days of becoming aware of any alleged infringement of Third Party proprietary rights in connection with performance by Hovione of the Development Services or Manufacturing Services under this Agreement that would constitute a breach of the warranty in Section 13.2

 

13.3               Mutual Representations and Warranties.  Hovione and Client each represent and warrant to the other that:

 

(a)                                  It is, and shall remain, a corporation duly organized, validly existing and in good standing under the laws of its jurisdiction of organization.

 

(b)                                 The execution and delivery of this Agreement has been authorized by all requisite corporate action.  This Agreement is and shall remain a valid and binding obligation of the executing Party, enforceable in accordance with its terms, subject to laws of general application relating to bankruptcy, insolvency and the relief of debtors.

 

(c)                                  It is under no contractual or other obligation or restriction that is inconsistent with its execution or performance of this Agreement.

 

13.4               DISCLAIMER OF WARRANTIES.  EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY OTHER WARRANTIES, OR REPRESENTATIONS UNDER THIS AGREEMENT EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT, AND ALL SUCH WARRANTIES ARE HEREBY DISCLAIMED BY EACH PARTY.

 

SECTION 14.                          INDEMNIFICATION, LIABILITY AND INSURANCE.

 

14.1               Client Indemnification.  Client will defend, indemnify and hold harmless Hovione and its Affiliates and their respective employees, directors and agents (the “Hovione Indemnified Parties”) against any liability, judgment, damage, cost and other expense (including reasonable attorney’s fees) (“Liability”) incurred in connection with any Third Party  claims, demands or lawsuits in each case only to the extent arising from: (i) the gross negligence or willful misconduct of any Client Indemnified Party, as defined in Section 14.2; (ii) the development, use, promotion, marketing, sale, distribution, packaging, labeling, handling, storage, import and/or disposal of Product (including without limitation any claim of 

 

33

 

infringement of any patent or trademark or the unauthorized use of a trade secret and any product liability claims) by Client or any of its Affiliates or any of their respective licensees, except in any case under this clause (ii), to the extent that such claim, demand or lawsuit results from any act or omission for which Hovione is obligated to indemnify Client under Section 14.2; (iii) a claim that Hovione’s use of Client Background Intellectual Property Rights in the performance of Services under this Agreement infringes any patent or other proprietary rights of a Third Party; or (iv) breach of this Agreement by Client.

 

14.2               Hovione Indemnification.  Hovione will defend, indemnify and hold harmless Client, its Affiliates, and their respective employees, directors and agents (the “Client Indemnified Parties”) against any Liability incurred in connection with any Third Party claims, demands or lawsuits in each case only to the extent arising from: (i) the gross negligence or willful misconduct of any Hovione Indemnified Party; (ii) a claim that Hovione Background Intellectual Property or Hovione Improvements used by Hovione in the performance of Services under this Agreement infringes any patent or other proprietary rights of a Third Party; (iii) subject to Section 6.6(e), failure of the Product supplied under this Agreement to conform to the Manufacturing Standards; or (iv) breach of this Agreement by Hovione.

 

14.3               Claims and Proceedings.

 

(a)                                  Each Party will notify the other Party promptly in writing of any threatened or pending claim or proceeding covered by this Section 14 and will include sufficient information to enable the other Party to assess the facts; provided, however, the failure to provide such notice within a reasonable period of time will not relieve the indemnifying Party of its obligations under this Section 14 except to the extent the indemnifying Party is materially prejudiced by such failure.  Subject to Section 14.3(b), the indemnifying Party will have the right to defend, negotiate, and settle such claims.  The indemnified Party will cooperate in good faith with the indemnifying Party, at the indemnifying Party’s request and expense, in the defense of all such claims for which indemnification is sought, with the indemnifying Party being permitted to maintain control of such defense through legal counsel selected by such Party.  The indemnified Party shall be entitled to participate in the defense of such matter and to employ counsel at its own expense to assist therein; provided, however, that the indemnifying Party shall have final decision-making authority regarding all aspects of the defense of any claim.  The Parties understand that no insurance deductible will be credited against losses for which a Party is responsible under this Section 14.

 

(b)                                 Unless the indemnified Party otherwise expressly consents in writing, the indemnified Party will not be bound by a settlement or compromise entered into without its prior written consent unless the settlement contains an absolute waiver of liability for the indemnified Party and no admission of wrong-doing on behalf of the indemnified Party, and indemnifying Party has acted in compliance with the requirements of Section 14.3(a).  In no event will the indemnifying Party have any liability with respect to any settlement entered into without the indemnifying Party’s prior written consent.

 

14.4               Limitation of Liability.  NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL, PUNITIVE, OR  INDIRECT DAMAGES ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY.  THIS LIMITATION SHALL APPLY EVEN IF

 

34

 

THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE; PROVIDED, HOWEVER, THAT THIS LIMITATION SHALL NOT APPLY TO DAMAGES RESULTING FROM BREACHES BY A PARTY OF ITS DUTY OF CONFIDENTIALITY AND NON-USE IMPOSED UNDER SECTION 11.  NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, NOTHING IN THIS SECTION 14.4 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER THIS SECTION 14.  The total liability of Hovione under this Agreement (other than for Liability arising under Section 9.2, 11 or 14.2) shall be limited to the amount received by Hovione from Client for Services under this Agreement over the * immediately prior to the occurrence, provided that, with respect to Hovione’s credit or reimbursement obligation under Section 6.6(c), Hovione’s liability cap will not be less than * in any year.

 

14.5               Insurance.  During the Term of this Agreement and thereafter until expiration of all Product Manufactured under this Agreement, each Party will maintain in full force and effect insurance in an amount of not less than * Dollars * for each incident or occurrence and in the aggregate.  At the request of a Party, the other Party will furnish the other with a certificate of insurance evidencing that it has such insurance coverage in force.

 

SECTION 15.                          ADDITIONAL HOVIONE RESPONSIBILITIES AND SCOPE OF RELATIONSHIP

 

15.1               Approvals.  Hovione is responsible for obtaining and maintaining, at Hovione’s cost, all approvals from any Regulatory Authority in the U.S., the European Union and Japan, or as otherwise required under Applicable Law, required to perform the Development Services and Manufacturing Services and for creating and maintaining all documentation required by such Regulatory Authorities in the Territory in respect of the performance of the Development Services and Manufacturing Services.

 

15.2               Qualifications of Hovione Personnel.  Hovione has, and will engage, employees and permitted subcontractors and/or consultants (“Hovione Personnel”) with the proper skill, training and experience to provide Development Services and Manufacturing Services.  Hovione will be solely responsible for paying Hovione Personnel and providing any employee benefits that they are owed.  Before providing Development Services and Manufacturing Services, all Hovione Personnel must have agreed in writing to (i) confidentiality obligations consistent with the terms of this Agreement, and (ii) effectively vest in Hovione any and all rights that such personnel might otherwise have in the results of their work.

 

15.3               Nonexclusive.  Subject to the limitations set forth in Sections 2.7, Hovione shall be free to provide services to Third Parties that are similar to or the same as the Development Services and Manufacturing Services, in each case provided that such activity does not require disclosure or use of the Confidential Information of Client or Client Background Intellectual Property, Development Deliverables or Product-Related Improvements.  Similarly, subject to Section 4.1, Client shall remain entitled to appoint Third Parties to perform services similar to the Development Services or Manufacturing Services, including appointing Third Parties to manufacture Product for research, clinical or commercial uses provided that, except as permitted under Sections 9.6, 10.3 and 11.3, such activity does not require disclosure of the Confidential Information of Hovione.

 

35

 

SECTION 16.                          ASSIGNMENT AND SUBCONTRACTING.

 

(a)                                  Assignment.  Neither Party may assign or transfer this Agreement without the prior written consent of the other Party.  Notwithstanding the foregoing, either Party may assign this Agreement, without the other Party’s consent, to any purchaser of all or substantially all of such Party’s assets, or the assets to which this Agreement relates, or to any successor, by way of merger, consolidation or similar transaction.  Either Party may also assign this Agreement to its Affiliate if in the case of Hovione the assignee has manufacturing resources and assets at least as substantial as Hovione, but does not manufacture a product competitive to the Product, or in the case of Client, the assignee has financial resources and assets at least as substantial as Client. Any successor in interest of a Party shall assume all obligations under this Agreement including, in the case of a successor in interest to Hovione, the obligation to utilize the Facility in the performance of Services.  Subject to the foregoing, this Agreement will be binding upon, enforceable by, and inure to the benefit of the Parties and their respective successors and assigns.

 

(b)                                 Subcontracting.  Hovione may not subcontract the performance of any of its obligations under this Agreement that are specific to the Manufacture of Product or are part of the Manufacturing Process as set forth in the Master Batch Documentation unless expressly permitted under the applicable Work Plan or otherwise with the prior written consent of Client, and then only to qualified Third Parties.  In the event that subcontracting is permitted under the preceding sentence, Hovione shall ensure that its agreement with any subcontractor is consistent with the terms of this Agreement, including, but not limited to, the rights and licenses granted to Client under Sections 9 and 10 and Hovione will be fully liable for performance of such subcontractor with the terms of this Agreement.  For the avoidance of doubt, nothing in this Section 16(b) is intended to require approval of subcontractors who are generally used by Hovione to maintain and operate its Facility and not to Manufacture Product.

 

SECTION 17.                          NOTICES.

 

All notices hereunder will be in writing and will be delivered personally, by internationally recognized one or two-day courier service, registered or certified mail, postage prepaid, return receipt requested to the following address of the respective Party:

 

If to Client:

 

TESARO Inc.

1000 Winter Street

Suite 3300

Waltham, MA  02451

USA

	
Attention:
    	
Richard J. Rodgers
    
	
 
    	
Executive Vice President and Chief Financial Officer
    

 

With a copy to:

 

	
 
    	
Asher   M. Rubin

Hogan   Lovells US, LLP

100   International Drive, Suite 2000

Baltimore,   MD 21202
    

 

36

 

If to Hovione Inter Limited:

 

Hovione Inter Limited

40 Lake Drive

East Windsor, NJ 08520

Attention:  VP Exclusives and Particle Design Business Units

 

With copies to:

 

	
 
    	
Hovione FarmaCiencia SA
    
	
 
    	
Sete Casas
    
	
 
    	
2674-506 Loures
    
	
 
    	
Portugal
    
	
 
    	
Attn: Chief Executive Officer
    
	
 
    	
 
    
	
and:
    	
Faber Daeufer Itrato & Cabot PC
    
	
 
    	
950 Winter Street
    
	
 
    	
Suite 4500
    
	
 
    	
Waltham, MA 02451
    
	
 
    	
Attn: Brian M. Connelly
    

 

Notices will be effective upon receipt if personally delivered, on the third business day following the date of mailing if sent by certified or registered mail, and on the second business day following the date of delivery if sent by one or two day courier service.  A Party may change its address listed above by written notice to the other Party provided in accordance with this Section.

 

SECTION 18.                          APPLICABLE LAW; DISPUTE RESOLUTION; ARBITRATION; INJUNCTIVE RELIEF

 

18.1               Choice of Law.  This Agreement will be construed, interpreted and governed by the laws of the State of New York, excluding any choice of law provision that would dictate the application of the laws of another jurisdiction.  The Parties expressly reject any application to this Agreement of (i) the United Nations Convention on Contracts for the International Sale of Goods, and (ii) the 1974 Convention on the Limitation Period in the International Sale of Goods, as amended by that certain Protocol adopted in Vienna on April 11, 1980.

 

18.2               Dispute Resolution.  The Parties recognize that bona fide disputes may arise which relate to the Parties’ rights and obligations under this Agreement.  Except as otherwise expressly set forth in this Agreement including, but not limited to, Section 6.5, in such event the Parties shall first, prior to proceeding under Section 18.3, try to settle such dispute amicably among themselves by referring such dispute, controversy or claim (a “Dispute”) (a) to the Joint Project Team for resolution, and (b) if the Joint Project Team fails to come to consensus on such Dispute within twenty (20) days of referral, then referring such Dispute to the Parties’ respective chief executive officers, or any other executive officer designated by such chief executive officer (the “Executive Officers”).  A dispute shall be referred to such Executive Officers upon one Party providing the other Party with written notice of referral of such Dispute to the Executive Officers.   The Parties agree to attempt to resolve such Dispute through good faith discussions.  If the Executive Officers fail to come to consensus on such Dispute within twenty (20) days of receipt of such written notice then either Party is free to initiate the dispute resolution procedures set forth in Section 18.3.

 

37

 

18.3               Arbitration.  Except as otherwise expressly set forth in this Agreement, the Parties agree that any dispute not resolved by the Parties pursuant to Section 18.2 will be resolved by arbitration in accordance with the then current Commercial Arbitration Rules of the American Arbitration Association (“AAA”) except that, to the extent such rules are inconsistent with this Section 18.3, this Section 18.3 will control.  The following rules will apply to any such arbitration:

 

(a)                                  Any demand for arbitration must be made in writing to the other Party.

 

(b)                                 There will be three arbitrators, one of whom shall be appointed by each Party and a third of whom shall be the chairman of the panel and be appointed by mutual agreement of the two arbitrators appointed by the Parties.  If the two arbitrators cannot agree on the appointment of the third arbitrator within thirty (30) days, then the AAA shall select the arbitrator.  All three arbitrators will have at least * of (i) dispute resolution experience (including judicial experience) or (ii) legal or business experience in the biotech or pharmaceutical industry.  Any arbitration involving patent rights, other intellectual property rights or intellectual property will be heard by arbitrators who are expert in such areas.

 

(c)                                  The arbitration will be held in New York City, New York, or such other place as the Parties agree.  The arbitrators will apply the substantive law specified in Section 18.1 except that the interpretation and enforcement of this arbitration provision will be governed by the United States Federal Arbitration Act, 9 U.S.C. Section 1 et. seq.

 

(d)                                 There shall be a stenographic record of the proceedings.  The decision of the arbitrators will be final and binding upon both Parties.  The arbitrators will render a written opinion setting forth findings of fact and conclusions of law on each issue.  Each Party agrees that, notwithstanding any provision of applicable law, it will not request, and the arbitrators shall have no authority to award damages against any Party that exceed the limits set forth in Section 14.4, to the extent applicable.

 

(e)                                  The expenses of the arbitration will be borne by the Parties in proportion as to which each Party prevails or is defeated in arbitration.  Each Party will bear the expenses of its counsel and other experts.

 

18.4               Injunctive Relief.  Notwithstanding anything contained in Section 18, either Party may seek preliminary or injunctive measures or relief in any competent court having jurisdiction.

 

SECTION 19.                          FORCE MAJEURE.

 

Any delay in the performance of any of the duties or obligations of any Party (except the payment of money due hereunder for Services rendered) caused by an event outside the affected Party’s reasonable control will not be considered a breach of this Agreement, and unless expressly provided to the contrary this Agreement, the time required for performance will be extended for a period equal to the period of such delay.  Such events will include without limitation, acts of God; acts of the public enemy; insurrections; riots; injunctions; embargoes; labor disputes, including strikes, lockouts, job actions, or boycotts; fires; explosions; floods; earthquakes; shortages of material or energy; delays in the delivery of raw materials, or other unforeseeable causes beyond the reasonable control and without the fault or negligence of the Party so affected (a “Force Majeure Event”).  The Party so affected will, to the extent reasonably possible, give prompt written notice to the other Party of such Force

 

38

 

Majeure Event, will take whatever reasonable steps are possible to mitigate the effect of such Force Majeure Event.  Client may cancel without paying a cancellation fee or incurring other penalty any firm Purchase Orders applicable to any period following the date of the Force Majeure Event that Hovione cannot reasonably fulfill for a period of at least ninety (90) days.  Upon cessation of such Force Majeure Event, the affected Party will promptly resume performance on all accepted Purchase Orders and other Services, which have not been terminated.

 

SECTION 20.                          MISCELLANEOUS.

 

20.1               Severability.  If any term or provision of this Agreement is for any reason held by a proper authority to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability will not affect any other term or provision hereof, and each such invalid, illegal or unenforceable term or provision will be changed and interpreted so as to be valid, legal and enforceable, and as similar in terms to such invalid, illegal or unenforceable provision as may be possible while giving effect to the benefits and burdens for which the Parties have bargained hereunder.

 

20.2               Entire Agreement: Amendments.  This Agreement constitutes the entire agreement between the Parties concerning the subject matter hereof and, as of the Effective Date, supersedes all written or oral prior agreements or understandings with respect thereto including, but not limited to the, Mutual Non-Disclosure Agreement between the Parties dated January 27, 2011 (the “CDA”).  No amendment or modification to this Agreement will be effective unless it is in writing and signed by authorized representatives of both Parties to this Agreement.

 

20.3               Waiver.  No waiver by a Party of any right hereunder or failure to enforce a breach of any of the terms of this Agreement will be valid unless in writing and signed by an authorized representative of each Party hereto.  Failure by either Party to enforce any rights under this Agreement will not be construed as a waiver of such rights, nor will a waiver by either Party in one or more instances be construed as constituting a continuing waiver or as a waiver in other instances.

 

20.4               Appendices.  All Appendices and exhibits referenced herein are hereby made a part of this Agreement.

 

20.5               Counterparts.  This Agreement may be executed in any number of separate counterparts, including .pdf versions, each of which will be deemed to be an original, but which together will constitute one and the same instrument.

 

20.6               Public Announcements.  Except as otherwise set forth in Section 11.4, neither Party will issue or make any public announcement, press release or other public disclosure regarding this Agreement or its subject matter without the other Party’s prior written consent, unless such disclosure is consistent with a disclosure previously approved by the other Party under this Section and such consent permitted such further disclosures without further review.  In the event a Party is required to make a public disclosure by law or the rules of a stock exchange on which its securities are listed for which consent is necessary under the preceding sentence, such Party will submit the proposed disclosure in writing to the other Party for such Party’s prior written consent which such consent shall not be unreasonable withheld, delayed or conditioned.  In the event no objection is made to a required disclosure submitted by one Party to the other Party under the preceding sentence within * business days of a written request and

 

39

 

receipt of such request was acknowledged in writing by the other Party or confirmed in another manner, written consent will be deemed to have been given.

 

20.7               Relationships.  The relationship between the Parties to this Agreement is that of independent contractors and nothing herein will be deemed to constitute the relationship of partners, joint ventures, nor of principal and agent between Hovione and Client.  Neither Party will have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract or undertaking with any Third Party.

 

20.8               Headings.  The headings in this Agreement are for convenience of reference only and will not affect its interpretation.

 

20.9               Definitional and Interpretative Provisions.  The words “hereof”, “herein” and “hereunder” and words of like import used in this Agreement shall refer to this Agreement as a whole and not to any particular provision of this Agreement.  Whenever the words “include”, “includes” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation”, whether or not they are in fact followed by those words or words of like import.  The word “or” is used in the inclusive sense (and/or).  “Writing”, “written” and comparable terms refer to printing, typing and other means of reproducing words (including electronic media) in a visible form.

 

40

 

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their duly authorized representatives on the later day and year written below.

 

 

	
TESARO, Inc.
    	
 
    	
Hovione Inter Limited
    
	
 
    	
 
    	
 
    
	
By:
    	
 
    	
 
    	
By:
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
 
    	
 
    	
Title:
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date:
    	
 
    	
 
    	
Date:
    	
 
    

 

41

 

APPENDIX A

 

Client Supplied Materials

 

*

 

 

APPENDIX B

 

Sample Work Plan

 

This Work Plan [#], dated                   , (the “Work Plan Date”) is by and between Hovione Inter Limited, a Swiss corporation, having a principal place of business at Bahnhofstrasse 21 CH-6000 Lucerne 7 Switzerland (together with its Affiliates “Hovione”), and TESARO Inc., a Delaware corporation, having a principal place of business at 309 Waverly Oaks Road, Suite 101, Waltham, MA 02452 (“Client”) and upon execution by both Parties, shall be incorporated into the Process Development And Manufacturing Services Agreement between Client and Hovione effective [insert effective date] (the “Agreement”). Capitalized terms used in this Work Plan shall have the meanings ascribed to them in the Agreement.

 

Hovione shall render to Client the following Services: [Work Plans will contain the following as applicable:]

 

1.                                       Background

2.                                       Scope of Work

3.                                       Description of Services

4.                                       Responsibilities (for commercial, that would include forecasts, firm POs, ordering and maintaining raw materials and qualified vendors, validation of equipment and processes, PAI readiness, replacement of non-conforming batches, etc.)

5.                                       Regulatory Requirements

6.                                       Quality Agreement Level/Requirements

7.                                       Specifications or Other Requirements (also included as Exhibits to Work Plan)

8.                                       Materials (including authorized vendors, who is responsible to buy)

 

[Client- Supplied Materials:

 

·                  Identify if any Client —supplied materials in addition to those identified in Appendix A will be supplied by Client. Identify

 

 

when such Client-Supplied Materials must be at the Hovione Facility for Services to commence

 

9.                                       Timeline

10.                                 Deliverables (including minimum yield requirements)

 

1.1                     [Reports:

 

1.2                     Status Reports:  While Services are ongoing, Hovione will provide to Client, on a monthly [IDENTIFY OTHER FREQUENCY IF APPLICABLE] basis, detailed written reports on the status and results to date of the Development Services.

 

1.3                     Final Report:  Hovione will provide a final report describing in detail the results of Development Services under this Work Plan within thirty (30) days [IDENTIFY OTHER DELIVERY DATE IF APPLICABLE] of completion of all activities under this Work Plan. ]

 

11.                                 Shipping/Storage Requirements

12.                                 Pricing Terms (including price increase frequency and caps)

13.                                 Any other terms and conditions not covered in MSA

14.                                 Exhibits to the Work Plan (e.g. specifications, synthesis pathways, Quality Agreement)

 

WORK PLAN AGREED TO AND ACCEPTED BY:

 

	
TESARO Inc.
    	
 
    	
Hovione Inter Limited
    
	
 
    	
 
    	
 
    
	
By:
    	
 
    	
By:
    
	
 
    	
 
    	
 
    
	
Name:
    	
 
    	
Name:
    
	
 
    	
 
    	
 
    
	
Title:
    	
 
    	
Title:
    

 

 

APPENDIX C

 

Description of Product

 

Rolapitant, also known as SCH 619734, is a selective, competitive neurokinin-1 receptor antagonist.

 

*

 

The structure of rolapitant is provided below.

 

 

Chemical Name: (5S ,8S)-8-[[(1R)-1-[3 ,5-
 Bis(trifluoromethyl)phenyl] ethoxy] methyl]-8-phenyl-1,7- 
 diazaspiro[4.5]decan-2-one hydrochloride monohydrate

 

Empirical Formula: C25H26F6N2O2 · HCl · H2O

 

Molecular Weight:  555

 

USAN Name: Rolapitant hydrochloride

 

INN Name:  rolapitantum or rolapitant

 

CAS Number: 914462-92-3

 

 

APPENDIX D

 

Initial Work Plan

 

See attached.

 

 

Bid for Analytical Support & Production of
 Three (3) x 8-9kg Registration Batches of Rolapitant

 

	
Bid issued to:
    	
Tesaro, Inc
    
	
 
    	
 
    
	
Bid date:
    	
January 13, 2012
    
	
 
    	
 
    
	
Bid reference:
    	
HOV-02889-85WN
    

 

1.              Background

 

*

 

2.              Scope of Work

 

We are bidding for the deliverables and Project Scope as requested by Tersaro which we understand to be the Manufacture of Rolapitant (SCH619734; Hovione code TR68) as outlined in the RFQ dated February 1, 2011 including any modifications agreed upon between the parties based on *

 

3.              Quality Agreement Level/Regulatory Requirements
  Work produced under this Work Plan will be in accordance with cGMP Level B as outlined in the project quality agreement agreed upon between the Parties.

 

4.              Specifications - As agreed upon between the Parties in advance of the manufacture. For reference, the Parties anticipate the specifications to be substantially similar to those outlined in the CofA under Appendix B.

 

5.              Client Supplied Materials
  Tesaro will provide no less than 18 kg of GB, 36 kg of KM and 0.396kg of Grubb’s required to produce 9kg of TR68 free of charge to Hovione.

 

6.              Pricing/Timeline/Deliverables

 

*

 

7.              Payment Terms

 

*

 

8.              Miscellaneous:

 

*

 

	
WORK PLAN AGREED TO AND ACCEPTED BY:
    	
 
    
	
 
    	
 
    
	
TESARO Inc.
    	
Hovione Inter Limited
    
	
 
    	
 
    
	
By:
    	
By:
    
	
 
    	
 
    
	
Name:
    	
Name:
    
	
 
    	
 
    
	
Title:
    	
Title:
    

 

 

Appendix A: Safety Testing

 

*

 

[End of Appendix A]

 

 

	
 
    	
*
    
	
 
    	
 
    
	
 
    	
*
    

 

Appendix B: Specifications

 

CERTIFICATE OF ANALYSIS

 

*

 

[End of Appendix B]

 

 

Appendix C: PAR STUDY ESTIMATES

 

*

 

[End of Appendix C]

 

 

Appendix D: VALIDATION ESTIMATES

 

*

 

[End of Appendix D]

 

 

Appendix E: COMMERCIAL ESTIMATES

 

*

 

[End of Appendix E]

 

 

Appendix F: Stability Plan

 

*

 

[End of Appendix F]

 

 

APPENDIX G: Terms & Conditions

 

TERMS AND CONDITIONS TO PURCHASE ORDER NO.                    

 

Between

Tesaro, Inc. (“Tesaro”)

and

Hovione Inter Limited (“Hovione”)

 

Tesaro has requested and Hovione agrees to perform Services as outlined hereunder for Tesaro’s Rolapitant proprietary compound.

 

It is the Parties intent to have this Bid as a Work Plan under the terms and conditions of the Process Development and Manufacturing Services Agreement (MSA) currently being negotiated between the Parties, which the Parties are anticipating to be completed no later than January 30, 2012. When signed by Tesaro and Hovione and attached to Purchase Order No                   , the terms of the MSA will apply. Until the time that said MSA is signed, the Terms and Conditions hereunder will constitute a binding Agreement (the “Agreement”) between Hovione and Tesaro for Hovione’s performance of the services described hereunder (the “Services”) on the terms set forth in this Agreement. For avoidance of doubt, Tesaro and Hovione intend that these Terms and Conditions will govern the Services and that any other terms or conditions, including but not limited to, any such terms or conditions contained in an accompanying Purchase Order No.                   , will have no force or effect.

 

3.              RIGHTS TO DATA AND CONFIDENTIAL INFORMATION

 

a)              The parties acknowledge and agree that the terms of that certain Mutual Confidentiality Agreement dated January 27, 2011 between Tesaro and Hovione’s affiliate, Hovione Inter Limited (the “Confidentiality Agreement”) will govern the parties’ rights and obligations relating to CONFIDENTIAL INFORMATION (as that term is defined in such Confidentiality Agreement) for purposes of this Agreement and such Confidentiality Agreement is incorporated into this Agreement by this reference, except that, for purposes of this Agreement the purposes for which CONFIDENTIAL INFORMATION may be used or exchanged between the parties will be deemed to include carrying out the activities contemplated under this Agreement.

 

b)              Each party will retain all right, title and ownership in all and to all materials, methods, techniques, trade secrets, copyrights, know-how, data, documentation, regulatory submissions, specifications or other intellectual property of any kind (whether or not protectable under patent, trademark, copyright or similar laws) that is developed or obtained by or on behalf of such party (i) prior to the date of this Agreement, or (ii) independent of this Agreement and without the use of CONFIDENTIAL INFORMATION provided by the other party. Notwithstanding the foregoing, any project-specific data generated by Hovione during the course of performing its obligations under this Agreement will be the property and CONFIDENTIAL INFORMATION of Tesaro.

 

c)              Any and all discoveries, improvements and/or inventions (“Improvements”) by Hovione, whether patentable or not, resulting from Hovione’s use of Tesaro CONFIDENTIAL INFORMATION in the course of performing its obligations under this Agreement, other than Hovione Technology Improvements (as defined below), shall be the sole and exclusive property of Tesaro, and shall be deemed to be Tesaro CONFIDENTIAL INFORMATION for purposes of this Agreement. Hovione will promptly notify Tesaro, in writing, of any such discovery, improvement, or invention and shall reasonably assist Tesaro, at Tesaro’s expense, in protecting Tesaro’s proprietary rights to said Improvements. Hovione Technology

 

 

Improvements shall be the sole and exclusive property of Hovione, and shall be deemed Hovione CONFIDENTIAL INFORMATION for purposes of this Agreement. “Hovione Technology Improvements” means all Improvements that relate to (a) CONFIDENTIAL INFORMATION of Hovione or (b) methods, techniques, trade secrets, copyrights, know-how, data, documentation, regulatory submissions, specifications or other intellectual property of any kind (whether or not protectable under patent, trademark, copyright or similar laws) that is developed or obtained by or on behalf of Hovione (i) prior to the date of this Agreement, or (ii) independent of this Agreement and without the use of CONFIDENTIAL INFORMATION provided by Tesaro.

 

4.              INDEMNITY

 

a)              Indemnification by Hovione. Hovione shall indemnify and hold harmless Tesaro and its Affiliates, and its and their directors, officers, employees and agents (“Tesaro Indemnitees”) from and against any and all damages, liabilities, claims, costs, charges, judgments and expenses, including reasonable attorneys’ fees (collectively “Losses”) that may be sustained, suffered or incurred by a Tesaro Indemnitee in connection with any and all actions, claims or demands that may be brought or instituted against a Tesaro Indemnitee by any third party, in each case only to the extent such Losses arise directly from or by reason of (a) the breach by Hovione of any warranty, representation or covenant of Hovione in this Agreement, or (b) Hovione’s gross negligence or willful misconduct, except in each case to the extent Customer is obligated to indemnify Hovione under Section 2b below.

 

b)              Indemnification by Tesaro. Tesaro shall indemnify and hold harmless Hovione and its Affiliates, and its and their directors, officers, employees and agents (“Hovione Indemnitees”) from and against any and all Losses that may be sustained, suffered or incurred by a Hovione Indemnitee in connection with any and all actions, claims or demands that may be brought or instituted against a Hovione Indemnitee by any third party, in each case only to the extent such Losses arise directly from or by reason of (a) the manufacturing, packaging, marketing, distribution, import, use or sale by Tesaro or its Affiliates of Rolapitant (including without limitation any claim of infringement of any patent or trademark or the unauthorized use of a trade secret and any product liability claims), except to the extent that such claim or suit results from or arises out of any act or omission for which Hovione is obligated to indemnify Tesaro pursuant to Section 2a, (b) the breach by Tesaro of any warranty, representation or covenant of Tesaro in this Agreement or (c) Tesaro’s gross negligence or willful misconduct.

 

5.               LIMITATION OF LIABILITY; DISCLAIMER OF WARRANTIES:  NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT DAMAGES ARISING OUT OF THIS AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY. THIS LIMITATION WILL APPLY EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE; PROVIDED, HOWEVER, THAT THIS LIMITATION WILL NOT APPLY TO DAMAGES RESULTING FROM BREACHES BY A PARTY OF ITS DUTY OF CONFIDENTIALITY AND NONUSE IMPOSED UNDER herein AND THE CONFIDENTIALITY AGREEMENT OR SUCH PARTY’S INDEMNIFICATION OBLIGATIONS UNDER SECTION 2. Further, and notwithstanding anything to the contrary in this Agreement, the total liability of Hovione under this Agreement shall be limited to the value of the purchase order.

 

EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND UNDER THIS AGREEMENT, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE

 

 

REGARDING ANY SERVICES TO BE PROVIDED OR MATERIALS TO BE PRODUCED BY HOVIONE UNDER THIS AGREEMENT.

 

6.              ENTIRE AGREEMENT:  This Agreement and the Confidentiality Agreement constitute the entire agreement of the parties with regard to the subject matter set forth in this Agreement, and supersede all previous written or oral representations, agreements and understandings between Tesaro and Hovione regarding such subject matter. This Agreement may only be changed by a writing signed by authorized representatives of both parties. Without limiting the generality of the foregoing, any terms that are in addition to or different from the terms of this Agreement that are contained in any additional purchase order or similar document issued by Tesaro will be of no force or effect unless expressly accepted by Hovione in a separate written amendment to this Agreement.

 

7.              FORCE MAJEURE:  Neither party shall be liable to the other for failure to perform when and as specified in this Agreement if such failure to perform is caused by war, fire (outside of the reasonable control of the party claiming the force majeure), flood, strike, labor dispute, accident (outside of the reasonable control of the party claiming the force majeure), riot, act of God, act of governmental authority, or other contingencies beyond the control of the non-performing party interfering with said party’s ability to perform its obligations hereunder.

 

8.              GOVERNING LAW:  This Agreement shall be governed by the laws of the State of New Jersey without reference to any rules of conflict of laws.

 

9.              SEVERABILITY:  In the event that any provision of this Agreement shall be found to be void or unenforceable, such findings shall not be construed to render any other provision of this Agreement either void or unenforceable, and all other provisions shall remain in full force and effect unless the provisions which are invalid or unenforceable shall substantially affect the rights or obligations granted to or undertaken by either Tesaro or Hovione.

 

[End of Appendix G]

 

 

 

APPENDIX E

 

Hovione Proprietary Formats

 

Hovione considers the safety data embedded into the Master Batch Records (MBR) and Production Batch Records (PBR) to be Hovione’s confidential and proprietary information and as such should be treated as Hovione’s Confidential Information pursuant to Section 11 of the Agreement. Below is an example of a PBR for reference and for illustration purposes only.

 

*

 

 

APPENDIX F

 

Material Requiring Client Approval

 

*Exhibit 10.20

 

 

CONFIDENTIAL MATERIAL OMITTED AND FILED

SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

BRACKETED ASTERISKS DENOTE SUCH OMISSIONS.

 

 

 

CONFIDENTIAL

 

 

 

 

 

 

 

 

 

 

 

 

LICENSE AGREEMENT

 

by and between

 

MERCK SHARP & DOHME CORP.

 

and

 

TESARO, INC.

 

 

 

 

 

 

 

 

 

 

CONFIDENTIAL TREATMENT

 

 

LICENSE AGREEMENT

 

THIS LICENSE AGREEMENT (this “Agreement”), dated as of May 22, 2012 (the “Effective Date”), is by and between MERCK SHARP & DOHME CORP., a corporation organized and existing under the laws of New Jersey (“Merck”), and TESARO, INC., a corporation organized and existing under the laws of Delaware (hereinafter referred to as “Licensee”).  Merck and Licensee are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

 

WHEREAS, Merck has developed the Licensed Compounds, and Merck is seeking a licensee to further develop and commercialize the Licensed Compounds;

 

WHEREAS, Licensee desires to develop and commercialize the Licensed Compounds; and

 

WHEREAS, Licensee and Merck desire to enter into a license arrangement whereby Licensee will develop and commercialize the Licensed Compounds.

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, Licensee and Merck hereby agree as follows:

 

ARTICLE I - DEFINITIONS

 

As used in this Agreement, the following capitalized terms, whether used in the singular or plural, shall have the respective meanings set forth below:

 

1.01                    “Affiliate” shall mean any individual or entity directly or indirectly controlling, controlled by or under common control with a Party to this Agreement.  For purposes of this Agreement, the direct or indirect ownership of fifty percent (50%) or more of the outstanding voting securities of an entity, or the right to receive fifty percent (50%) or more of the profits or earnings of an entity, shall be deemed to constitute control.  Such other relationship as in fact results in actual control over the management, business and affairs of an entity shall also be deemed to constitute control.  For the purpose of this Agreement, New Enterprise Associates and its Affiliates shall not be deemed to be Affiliates of Licensee.

 

1.02                    “Calendar Quarter” shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31, for so long as this Agreement is in effect; provided, however, that (a) the first Calendar Quarter of the Term shall extend from the Effective Date to the end of the first full Calendar Quarter thereafter, and (b) the last Calendar Quarter of the Term shall end upon the expiration of this Agreement.

 

1.03                    “Calendar Year” shall mean each successive period of twelve (12) months commencing on January 1 and ending on December 31, for so long as this Agreement is in effect; provided, however, that (a) the first Calendar Year of the Term shall commence on the Effective Date and end on December 31, 2012 and (b) the last Calendar Year of the Term shall commence on

 

CONFIDENTIAL TREATMENT

 

2

 

January 1 of the Calendar Year in which this Agreement terminates or expires and end on the date of termination or expiration of this Agreement.

 

1.04                    “Clinical Trial” shall mean a Phase I Clinical Trial, Phase II Clinical Trial, Phase III Clinical Trial, and/or post-Marketing Authorization studies.

 

1.05                    “Combination Product” shall mean a Licensed Product which includes one or more active ingredients other than a Licensed Compound, in combination with a Licensed Compound.

 

1.06                    “Commercialization” or “Commercialize” with respect to a product shall mean any and all activities directed to the marketing, promotion, distribution, offering for sale and selling such product, importing and exporting such product for sale, and interacting with Regulatory Authorities regarding the foregoing.  Commercialization shall also include Commercialization Studies.

 

1.07                    “Commercialization Studies” shall mean a study or data collection effort for the Licensed Product that is initiated in the Territory after receipt of Marketing Authorization for the Licensed Product in a particular jurisdiction and is principally intended to support the Commercialization of the Licensed Product in such jurisdiction; provided, that such study or data collection effort is not principally to support or maintain a Marketing Authorization or obtain a label change or maintain a label.

 

1.08                    “Compound Patent Rights” shall mean   those patents and patent applications that are listed on Schedule 1.08 and claim the composition of matter or use of a Licensed Compound, together with all (a) substitutions, divisions, continuations, continuations-in-part, continued prosecution applications, reissues, renewals, registrations, certificates of invention, confirmations, re-examinations, extensions, supplementary protection certificates or the like, or the provisional applications of any such patents and patent applications and (b) foreign equivalents of any of the above.

 

1.09                    “Development” or “Develop” shall mean all preclinical research and development activities and all clinical drug development activities, including, among other things: drug discovery, toxicology, formulation, statistical analysis and report writing, conducting Clinical Trials for the purpose of obtaining and maintaining Marketing Authorization (including without limitation, post-Marketing Authorization studies), and regulatory affairs related to all of the foregoing.  Development shall include all Clinical Trials (including Phase III-B Clinical Trials) that are primarily intended to support or maintain a Marketing Authorization, maintain a label or obtain any label change, but shall exclude Commercialization Studies.

 

1.10                    “Diligent Efforts” shall mean the performance of obligations or tasks in a manner consistent with the reasonable practices of companies in the biopharmaceutical industry having similar financial resources for the Development or Commercialization (as applicable) of a product having similar technical and regulatory factors and similar market potential, profit potential and strategic value, and that is at a similar stage in its Development or product life cycle as the Licensed Product, in each case based on conditions then prevailing and without regard to any competitive internal program of Licensee. Diligent Efforts requires that the Party

 

CONFIDENTIAL TREATMENT

 

3

 

(a) promptly assign responsibility for such obligations to specific employees who are held accountable for progress and monitoring such progress on an ongoing basis, (b) set and consistently seek to achieve specific and meaningful objectives for carrying out such obligations, and (c) consistently make and implement decisions and allocate adequate resources designed to advance progress with respect to such obligations.

 

1.11                    “Field” shall mean the use of the Licensed Compounds or Licensed Product for any and all therapeutic and prophylactic uses in humans.

 

1.12                    “First Commercial Sale” shall mean, with respect to a country in the Territory, the first sale of commercial quantities of a Licensed Product in such country to a Third Party on arm’s length terms by Licensee, its Affiliate or sublicensee for use in the Field after the receipt of Marketing Authorization in such country.  Sales for test marketing, sampling and promotional uses, Clinical Trial purposes or compassionate or similar use shall not be considered to constitute a First Commercial Sale.

 

1.13                    “Good Clinical Practices” shall mean the then current Good Clinical Practices as such term is defined from time to time by the United States Food and Drug Administration (“FDA”), or analogous set of regulations, guidelines or standards as defined by other relevant Regulatory Authority having jurisdiction over the Development, Manufacture or sale of Licensed Product in a particular jurisdiction of the Territory, if and to the extent the Development, Manufacture or sale of Licensed Product takes place in such jurisdiction.

 

1.14                    “Good Laboratory Practices” shall mean the current good laboratory practice regulations of the FDA as described in the United States Code of Federal Regulations (“CFR”) or analogous set of regulations, guidelines or standards as defined by other relevant Regulatory Authority having jurisdiction over the Development, Manufacture or sale of Licensed Product in a particular jurisdiction of the Territory, if and to the extent the Development, Manufacture or sale of Licensed Product takes place in such jurisdiction.

 

1.15                    “Good Manufacturing Practices” shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or analogous set of regulations, guidelines or standards as defined by other relevant Regulatory Authority having jurisdiction over the Development, Manufacture or sale of Licensed Product in a particular jurisdiction of the Territory, if and to the extent the Development, Manufacture or sale of Licensed Product takes place in such jurisdiction.

 

1.16                    “IND” shall mean an investigational new drug application with respect to the Licensed Product filed with the FDA for beginning Clinical Trials in humans, or any comparable application filed with the Regulatory Authorities of a country other than the United States prior to beginning Clinical Trials in humans in that country, as well as all supplements or amendments filed with respect to such filings.

 

1.17                    “Know-How” shall mean any and all proprietary information and materials (whether patentable or not) related to the Licensed Compounds, Licensed Product, any formulation, product improvement and/or indication, or the Development, Manufacture, Commercialization or

 

CONFIDENTIAL TREATMENT

 

4

 

use of any of the foregoing, that are not in the public domain, including, without limitation, to the extent related to the foregoing, (a) ideas, discoveries, inventions, improvements, technology or trade secrets (including those related to combination treatments with the Licensed Compounds or Licensed Products), (b) pharmaceutical, chemical and biological materials, products, components or compositions, (c) methods, procedures, formulas, processes, tests, assays, techniques, regulatory requirements and strategies, (d) biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, clinical, safety, Manufacturing and quality control data and information related thereto, (e) technical and non-technical data and other information related to the foregoing, (f) drawings, plans, designs, diagrams, sketches, specifications or other documents containing or relating to such information or materials and (g) all applications, registrations, licenses, authorizations, approvals and correspondence relating to the Licensed Compounds and/or Licensed Product submitted to Regulatory Authorities, including without limitation Product Registration Data.

 

1.18                    “Licensee Know-How” shall mean any and all Know-How (a) developed or controlled by Licensee and/or any of its Affiliates or sublicensees on or after the Effective Date or (b) developed or controlled by Licensee and/or any of its Affiliates or sublicensees prior to the Effective Date but incorporated into, or primarily used in the Manufacture or Commercialization of, the Licensed Compound or Licensed Product.

 

1.19                    “Licensee Patent Rights” shall mean any and all patents and patent applications that after the Effective Date are owned or controlled by Licensee (and/or any of its Affiliates) that (a) have claims covering:  (i) the Licensed Compounds or the Manufacture and/or use thereof, or (ii) Licensed Product or the Manufacture and/or use thereof; (b) are substitutions, divisions, continuations, continuations-in-part, continued prosecution applications, reissues, renewals, registrations, certificates of invention, confirmations, re-examinations, extensions, supplementary protection certificates or the like, or the provisional applications of any such patents and patent applications; or (c) are foreign equivalents of any of the above.

 

1.20                    “Licensed Compounds” shall mean those certain Merck compounds currently known as:  (a) MK-4827 with the following chemical name: [**] and (b) MK-2512 with the following chemical name: [**], and with respect to both (a) and (b), shall include any pharmaceutically acceptable salt, polymorph, crystal form, prodrug or solvate thereof that but for the license granted in Section 2.01, would infringe the Compound Patent Rights.

 

1.21                    “Licensed Product”  shall  mean  any  pharmaceutical  composition,  dosage  form  or  preparation,  including, without limitation, a Combination Product, that contains as an active ingredient a Licensed Compound.

 

1.22                    “Major European Country” shall mean any of France, Germany, Italy, Spain or the United Kingdom.

 

1.23                  “Manufacture” shall mean all activities related to the manufacturing and having made of a pharmaceutical product, or any ingredient thereof, including but not limited to test method development and stability testing, characterization, formulation, process development, manufacturing for use in non-clinical or clinical studies, manufacturing scale-up, quality

 

CONFIDENTIAL TREATMENT

 

5

 

assurance/quality control development, quality control testing (including in-process release and stability testing), packaging, release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, and regulatory activities related to all of the foregoing.

 

1.24                    “Marketing Authorization” shall mean all approvals from the relevant Regulatory Authority necessary to market and sell a Licensed Product in any country (including without limitation all applicable Price Approvals even if not legally required to sell Licensed Product in a country).

 

1.25                    “Merck Know-How” shall mean Merck’s and its Affiliates’ Know-How as of the Effective Date concerning the Licensed Compounds as set forth in Schedule 1.25.

 

1.26                    “NDA” shall mean a New Drug Application, Biologics License Application, Worldwide Marketing Application, Marketing Application Authorization, filing pursuant to Section 510(k) of the United States Food & Drug Act, or similar application or submission for Marketing Authorization of a product filed with a Regulatory Authority to obtain marketing approval for a biological, pharmaceutical or diagnostic product in that country or in that group of countries.

 

1.27                    “Net Sales” shall mean the gross invoice price of Licensed Product sold by Licensee or its Related Parties to the first Third Party after deducting, if not previously deducted and in accordance with United States generally accepted accounting principles (“US GAAP”), from the amount invoiced:

 

(a)     trade and quantity discounts other than early payment cash discounts;

 

(b)     returns, rebates, chargebacks and other allowances;

 

(c)     retroactive price reductions that are actually allowed or granted;

 

(d)     sales commissions paid to Third Party distributors and/or selling agents;

 

(e)     deductions to gross invoice price of Product imposed by Regulatory Authorities or other governmental entities;

 

(f)      a fixed amount equal to [**] of the amount invoiced to cover bad debt, early payment cash discounts, transportation and insurance and custom duties; and

 

(g)     the standard inventory cost of devices or delivery systems used for dispensing or administering Product.

 

With respect to sales of Combination Products, Net Sales shall be calculated on the basis of the gross invoice price of Licensed Product(s) containing the same strength of Licensed Compound sold without other active ingredients.  In the event that Licensed Product is sold only as a Combination Product, Net Sales shall be calculated on the basis of the gross invoice price of the Combination Product multiplied by a fraction, the numerator of which shall be the inventory cost of Licensed Compound in the Licensed Product and the denominator of which shall be the inventory cost of all of the active ingredients in the Combination Product.  Inventory cost shall be determined in accordance with Licensee’s regular accounting methods, consistently applied.  The deductions set forth in Sections 1.27 (a) through (f) will be applied in calculating Net Sales

 

CONFIDENTIAL TREATMENT

 

6

 

for a Combination Product.  In the event that Licensed Product is sold only as a Combination Product and either Party reasonably believes that the calculation set forth in this Paragraph does not fairly reflect the value of the Licensed Product relative to the other active ingredients in the Combination Product, the Parties shall negotiate, in good faith, other means of calculating Net Sales with respect to Combination Products.

 

1.28                    “Non-Core Territory” shall mean all those countries in the Territory that are not the United States, Japan, China or a Major European Country.

 

1.29                  “PARP Inhibitors” shall mean compounds having a primary mechanism of action that inhibits poly (ADP-ribose) polymerase.

 

1.30                    “Party” or “Parties” shall have the meaning given to such term in the preamble to this Agreement.

 

1.31                    “Phase I Clinical Trial” shall mean a clinical trial of a Licensed Product in human patients at single and multiple dose levels with the primary purpose of determining safety, metabolism, and pharmacokinetic and pharmacodynamic properties of such Licensed Product, and which is consistent with 21 U.S. CFR § 312.21(a).  For the avoidance of doubt, a Phase I Clinical Trial may include studies of the Licensed Compounds with chemotherapy agents to determine combination doses thereof.

 

1.32                    “Phase II Clinical Trial” shall mean a clinical trial of a Licensed Product in human patients, the principal purposes of which are to make a preliminary determination that the Licensed Product is safe for its intended use, to determine its optimal dose, and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of Phase III Trials, and which is consistent with 21 U.S. CFR § 312.21(b).

 

1.33                    “Phase III Clinical Trial” shall mean a clinical trial of a Licensed Product in human patients, which trial is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use, (b) to define warnings, precautions and adverse reactions that are associated with such Licensed Product in the dosage range to be prescribed, (c) to be, either by itself or together with one or more other Clinical Trials having a comparable design and size, the final human Clinical Trial in support of Regulatory Approval of a Marketing Authorization application of such Licensed Product, and (d) consistent with 21 U.S. CFR § 312.21(c). “Phase III Trial” shall not include a Phase IIIb Trial.

 

1.34                    “Phase IIIb Clinical Trial” shall mean a clinical trial of a Licensed Product in human patients, which provides for product support (i.e., a clinical trial which is not required for receipt of initial Marketing Authorization but which may be useful in providing additional drug profile data or in seeking a label expansion) commenced before receipt of Marketing Authorization for the indication for which such trial is being conducted.

 

1.35                    “Price Approval” shall mean the approval or determination by a Regulatory Authority for the pricing or pricing reimbursement for a pharmaceutical product.

 

CONFIDENTIAL TREATMENT

 

7

 

1.36                    “Proprietary Information” shall mean, as applicable, Know-How and all other scientific, clinical, regulatory, marketing, financial and commercial information or data, whether communicated in writing, verbally or electronically, that is provided by one Party to the other Party in connection with this Agreement.

 

1.37                    “Regulatory Authority” shall mean any United States federal, state, or local government, or any foreign government, or political subdivision thereof, or any multinational organization or authority or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof), or any governmental arbitrator or arbitral body with responsibility for granting licenses or approvals, including Marketing Authorizations, necessary for the marketing and sale of the Licensed Product in any country.

 

1.38                    “Related Party” shall mean each of Licensee, its Affiliates, and their respective sublicensees (which term does not include distributors), as applicable.

 

1.39                      “Territory” shall mean the entire world.

 

1.40                    “Third Party” shall mean an entity other than Merck and its Affiliates and Licensee and its Related Parties.

 

1.41                    “U.S.” or “United States” shall mean the United States of America, including its territories and possessions.

 

1.42                    “Valid Claim” shall mean a claim of an issued and unexpired patent included within the Compound Patent Rights, that has not been revoked or held unenforceable 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 that has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue or disclaimer.

 

1.43                    Additional Definitions.  Each of the following definitions is set forth in the Section of this Agreement indicated below.

 

	
Definition
    	
Section
    
	
AAA
    	
13.02(a)
    
	
AEs
    	
4.02(a)
    
	
Agents
    	
9.01(b)
    
	
Agreement
    	
Preamble
    
	
CFR
    	
1.14
    
	
Change of   Control
    	
14.01(c)
    
	
Development   Plan
    	
3.02(a)
    
	
Development   Report
    	
3.03
    
	
Effective   Date
    	
Preamble
    
	
Excluded   Claim
    	
13.02
    
	
FDA
    	
1.13
    

 

CONFIDENTIAL TREATMENT

 

8

 

	
Force   Majeure
    	
14.08
    
	
Inventory
    	
4.01(a)
    
	
Liability
    	
11.01
    
	
LIBOR
    	
7.05(e)
    
	
Licensee
    	
Preamble
    
	
Licensee   Indemnified Party
    	
11.02
    
	
Merck
    	
Preamble
    
	
Merck   Indemnified Party
    	
11.01
    
	
Negotiation   Period
    	
3.05
    
	
Party and Parties
    	
Preamble
    
	
Sublicense   Agreement
    	
2.04
    
	
Term
    	
12.01
    

 

ARTICLE II - LICENSE

 

2.01                    License Grant.  Subject to the terms and conditions of this Agreement, Merck hereby grants to Licensee a royalty bearing license in the Territory in the Field, with the right to grant sublicenses as provided herein, under the Compound Patent Rights, which Compound Patent Rights license shall be exclusive (even as to Merck) and the Merck Know-How, which Merck Know-How license shall be non-exclusive, to Develop, Manufacture, have Manufactured, use, import, export and Commercialize the Licensed Compounds and the Licensed Products in the Field in the Territory during the Term.  The license granted in this Section 2.01 may be sublicensed by Licensee upon prior written notice to Merck; provided that, licenses granted solely in connection with Development (but not Commercialization), such as licenses to contract manufacturers, contract research organizations or clinical study sites, shall not require any notice to Merck.

 

2.02                    No Non-Permitted Use.  Licensee hereby covenants that it shall not, nor shall it cause,  permit or enable any Affiliate or sublicensee to knowingly use or practice, directly or indirectly, any Merck Know-How or Compound Patent Rights for any purposes other than those expressly permitted by this Agreement.

 

2.03                    No Other Licenses.  Neither Party grants to the other Party any rights or licenses in or to any intellectual property, whether by implication, estoppel, or otherwise, other than the license rights that are expressly granted under this Agreement.

 

2.04                    Sublicense Agreements.  Licensee shall, in each agreement under which it grants a sublicense under the license set forth in Section 2.01 (each, a “Sublicense Agreement”), require the Sublicense Agreement to be assignable by Licensee to Merck, and require the sublicensee to transfer to Merck, if so required under Section 12.05, (a) all regulatory filings and Marketing Authorizations held, possessed or controlled by such sublicensee and (b) all patent rights and Know-How controlled by such sublicensee relating to a Licensed Product or its use, Manufacture, sale, or importation (such  patent rights and Know-How shall be transferred either by assignment or by a freely sublicensable, royalty-free license, which license shall be exclusive for, and limited solely to use with, Licensed Products in the Field).  Any sublicense agreement shall be consistent with the terms and conditions of this Agreement, and shall include provisions 

 

CONFIDENTIAL TREATMENT

 

9

 

for the benefit of Merck corresponding to Articles III and IV and Sections 9.04, 9.05, 12.04 and 12.05.  Licensee shall (i) use reasonable efforts to procure the performance by any sublicensee of the terms of each such sublicense Agreement, and (ii) ensure that any sublicensee will comply with the applicable terms and conditions of this Agreement.  The grant of any such sublicense will not relieve Licensee of its obligations under this Agreement, except to the extent such obligations are satisfactorily performed by such Affiliate or sublicensee.  Licensee shall be liable for the performance or non-performance of its Affiliates and sublicensees hereunder.

 

2.05                    Section 365(n) of the Bankruptcy Code.  All rights and licenses granted under or pursuant to any section of this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code.  Each Party shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code or equivalent legislation in any other jurisdiction.  Upon the bankruptcy of either Party, the other Party shall further be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property, and such, if not already in its possession, shall be promptly delivered to such other Party, unless the Party in bankruptcy elects to continue, and continues, to perform all of its obligations under this Agreement.

 

2.06     PARP Inhibitor Exclusivity.  As partial consideration for Merck granting to Licensee the license set forth in Section 2.01, during the Term, Licensee shall not, and shall cause its Affiliates to not, itself or in cooperation with or through others, discover, research, develop, manufacture or commercialize any PARP Inhibitor other than the Licensed Compounds and Licensed Product hereunder.

 

ARTICLE III– DEVELOPMENT AND COMMERCIALIZATION

 

3.01                    Overview.  As of the Effective Date,  but without limitation of Merck’s obligations under Article IV and Article VI, Licensee shall be solely responsible for the Development and Commercialization, including all costs thereof, of the Licensed Product in the Field in the Territory.  Licensee shall perform all of its Development activities in accordance with the IND for the Licensed Product and with all applicable laws, rules and regulations.

 

3.02                    Development  and Commercialization Plans.

 

(a)          Initial Development Plan.  Not later than [**] days following the Effective Date, Licensee shall provide Merck with the initial Development plan for the Licensed Product in the Field in the Territory (the “Development Plan”).

 

(b)       Annual Development Plan.  Not later than [**] days after December 31 of each Calendar Year, Licensee shall submit to Merck an updated Development Plan for the pending Calendar Year.  Such update shall take into account completion, commencement, changes in or cessation of Development activities not contemplated by the then-current Development Plan in sufficient detail to reflect the continued diligence of Licensee and shall reflect effort and resources consistent with other priority projects of Licensee.  Merck shall have the right to comment on such annual plan.  In the event Merck reasonably disagrees with the plan, Licensee shall consider in good faith Merck’s comments for revising the plan.  At Merck’s written request, the President of Merck’s research division, or his designee, and the President of Licensee’s research division or

 

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equivalent position, or her designee, shall meet to discuss such comments.  Any revision of the annual plan shall be submitted to Merck promptly after its completion.

 

(c)            Performance.  Licensee shall perform, and shall ensure that its Affiliates, sublicensees, and Third Party contractors perform, the activities described in the Development Plan in compliance with, to the extent applicable, Good Laboratory Practices, Good Clinical Practices and/or Good Manufacturing Practices and in compliance with all other applicable laws, rules, and regulations.

 

3.03                    Development Reports.  Licensee shall provide Merck with reasonably detailed reports describing its progress with respect to its Development efforts under this Agreement (hereinafter “Development Reports”).  Such Development Reports shall be furnished annually, contemporaneously with the provision of the updated Development Plan in accordance with Section 3.02(b) so long as development of a Licensed Product continues.  Each Development Report shall include the following information for the Licensed Product: a description of the Development work to be conducted during the year in reasonable detail, including clinical studies, formulation work, manufacturing work, other testing work and regulatory activity; timelines for such work; and key decision gates and milestones for such work.

 

3.04                    Commercialization.  Licensee shall give Merck prior written notice of at least [**] days of its intent to file an NDA in a specific country or region for the Licensed Product and at that time shall further provide Merck with the anticipated date of First Commercial Sale for the Licensed Product in the country of filing.  Licensee shall promptly provide Merck with notice of the granting of any Marketing Authorization of Licensed Product.

 

3.05     Co-Promotion.    Merck shall have an exclusive and irrevocable right of first refusal to co-promote a Licensed Product in the Non-Core Territory.  From the date of receipt of Licensee’s notice of intent to file an NDA for a Licensed Product in a Non-Core Territory country pursuant to Section 3.04 above, Merck shall have sixty (60) days to exercise its right by sending written notice to Licensee to that effect.  Should Merck provide such notice to Licensee during that period, then the Parties shall conduct good faith negotiations for a definitive agreement establishing the terms and conditions for Merck to co-promote that Licensed Product with Licensee in the applicable country (or countries) and conclude such a definitive agreement within four (4) months from the date of such notice (the “Negotiation Period”).  In the event such a definitive agreement has not been concluded within the Negotiation Period, then Licensee may enter into an agreement with a Third Party to co-promote (or promote) that Licensed Product in the applicable country (or countries); provided that, for twelve (12) months after the expiration of the Negotiation period, Licensee may not enter into such an agreement with a Third Party on terms that are, on the whole, less favorable to licensee than those last proposed by Merck.  It is understood and agreed that this co-promotion right is on a country-by-country and Licensed Product-by-Licensed Product basis.

 

ARTICLE IV– REGULATORY; MATERIALS AND INFORMATION TRANSFER

 

4.01                    Materials and Regulatory Filings Transfer.

 

(a)           In partial consideration for the upfront payment to be made by Licensee pursuant to Section 7.01, as soon as is reasonably practicable following  the Effective Date (but in no event later than ninety (90) days after the Effective Date), Merck shall transfer to Licensee, in a mutually agreed manner, the then existing quantities of Licensed Compounds and/or Licensed Product in Merck’s inventory (the “Inventory”) as set forth on Schedule 1.25.  Licensee acknowledges and agrees that the Inventory (i) will include certain quantities of Licensed Compounds and Licensed Product that have been Manufactured in accordance with Good Manufacturing Practices and certain quantities that have not, (ii) will be received by Licensee “as-is” and without any particular warranties and any implied warranties are hereby disclaimed by Merck, and (iii) shall only be used in preclinical and clinical work (as applicable depending whether such Inventory was Manufactured in accordance with Good Manufacturing Practices), in the Field and shall not be used for Commercialization purposes.  Merck shall submit an invoice to Licensee after shipment of the Inventory that shall include all reasonable transfer costs, including shipping costs, and Licensee shall pay Merck the invoice amount

 

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within forty-five (45) days of receipt of the invoice.  In addition, within thirty (30) days of the Effective Date, Merck shall deliver to each vendor identified on Schedule 4.01-A, a letter indicating that the Licensed Compound has been transferred to Licensee and authorizing the vendors to interact directly with Licensee with respect to the Licensed Compound.

 

(b)           As soon as is reasonably practicable after the Effective Date (but in no event later than thirty (30) days after the Effective Date or such other date as may be mutually agreed by the Parties), (i) Merck shall execute and deliver a letter to the FDA authorizing the transfer to Licensee of ownership of the existing INDs and other drug approval applications covering the Licensed Product, and (ii) Licensee shall execute and deliver a letter to the FDA accepting the transfer to Licensee of ownership of the existing INDs and other drug approval applications covering the Licensed Product.  All further submissions to any Regulatory Authorities relating to such drug approval applications and/or INDs shall be filed in the name of and owned by Licensee or its Affiliates.  Licensee or its Affiliates shall hold all Marketing Authorizations for Licensed Product throughout the Territory.

 

(c)            As soon as is reasonably practicable after the Effective Date (but in no event later than sixty (60) days after the Effective Date or such other date as mutually agreed by the Parties), Merck shall transfer to Licensee one (1) electronic copy of (i) the material documents and records that have been generated by or on behalf of Merck with respect to any existing INDs and other drug approval applications covering the Licensed Product in the Territory, as well as any material correspondence between Merck and Regulatory Authorities related to Licensed Product,  and (ii) the Merck Know-How.

 

(d)           Licensee shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, the FDA and other Regulatory Authorities in the Territory with respect to Licensed Product.

 

(e)           Licensee shall be solely responsible for interfacing, corresponding and meeting with the FDA and other regulatory authorities throughout the Territory with respect to Licensed Product.  Licensee shall provide Merck with copies of any material correspondence with FDA or other regulatory authorities in the United States, the Major European Countries and Japan relating to approval of Licensed Product, and respond to all reasonable inquiries by Merck with respect thereto.  Licensee shall also provide Merck in a timely manner with meeting minutes from any material meetings with regulatory authorities in the United States, the Major European Countries and Japan concerning the approval of Licensed Product.

 

(f)              Licensee shall provide to Merck a table report on an annual basis that contains the status of Marketing Authorizations for the Licensed Product in the Territory.

 

(g)           In the event that any Regulatory Authority (a) threatens or initiates any action to remove a Licensed Product from the market in any country in the Field in the Territory or (b) requires Licensee, its Affiliates, or its sublicensees to distribute a “Dear Doctor” letter or

 

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its equivalent regarding use of Licensed Product in the Field, Licensee shall notify Merck of such event within one (1) business day after Licensee becomes aware of the action, threat, or requirement (as applicable).  Licensee shall use commercially reasonable efforts to advise Merck prior to initiating a recall or withdrawal of Licensed Product in the U.S., Japan, or a Major European Country; provided, however, that the final decision as to whether to recall or withdraw a Licensed Product in the Territory shall be made by Licensee in its sole discretion.  Licensee shall be responsible, at its sole expense, for conducting any recalls or taking such other necessary remedial action.

 

(h)           Merck’s obligations to provide assistance and support under this Section 4.01 shall not extend beyond six (6) months after the Effective Date.  Notwithstanding the foregoing, in the event required by applicable laws or in order to obtain Marketing Authorization, Licensee requires any original copies of any filings submitted to a Regulatory Authority related to the Licensed Compounds or other Merck Know-How that has not been delivered to Licensee (“Remaining Deliverables”), then to the extent such items are in existence and in the possession of Merck or its Affiliates, Merck shall use reasonable efforts to provide such original documentation promptly upon request of Licensee.  Further, Merck shall use reasonable efforts to advise Licensee of Merck’s intention to destroy any Remaining Deliverables and, prior to destroying any Remaining Deliverables, provide Licensee with the opportunity to obtain the Remaining Deliverables to be destroyed by Merck, at Licensee’s sole cost and expense (which cost and expense shall be reasonable).

 

4.02                    Pharmacovigilance.

 

(a)           Following the transfer of any INDs related to Licensed Product from Merck to Licensee, Licensee shall be solely responsible for the collection, review, assessment, tracking and filing of information related to adverse events (“AEs”) associated with Licensed Product, in accordance with 21 CFR 312.32, 314.80 and comparable regulations, guidance, directives and the like governing AEs associated with Licensed Product that are applicable outside of the United States.

 

(b)           As soon as is reasonably practicable following the transfer of the IND to Licensee (but in no event later than thirty (30) days after the transfer of the IND to Licensee), Merck will provide Licensee with an electronic copy of the CIOMS I forms of all legacy data of serious adverse events or experiences, as maintained by Merck on its global safety data base, copies of all study reports of completed studies (including copies of the protocols), and copies of all interim study analysis of all ongoing studies for Licensed Product (including copies of protocols) to the extent not previously provided to Licensee, all of which shall be readable by Licensee without the need for any proprietary information of Merck.

 

(c)            Within a reasonable period of time following receipt of all such information described in this Section 4.02, and in no event not later than forty-five (45) days after the receipt of such information, Licensee shall assume responsibility for maintaining a global safety database for Licensed Product consistent with industry practices.

 

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ARTICLE V- DILIGENCE

 

5.01                    Generally.  Licensee shall use Diligent Efforts to Develop and Commercialize Licensed Products in the Field (a) in the United States, Major European Countries, China and Japan, and (b) in such other Non-Core Territories in the Territory for which Licensee determines, in its sole discretion, that Commercialization of the Licensed Products is commercially reasonable.

 

5.02                    Specific Obligations.  Without limiting the generality of Section 5.01, Licensee shall (a) within twelve (12) months after the Effective Date, submit to Merck for review and consideration an update to the Development Plan proposing activities for the Development of the Licensed Product, (b) use Diligent Efforts to Develop, obtain Marketing Authorization for and Commercialize at least one Licensed Product hereunder, and (c) undertake the commercial launch of any Licensed Product in a country promptly after, and in any case not later than six (6) months after, the date that the final Marketing Authorization is granted with respect to such country, unless such country is a Non-Core Territory with respect to which Licensee determines, in its sole discretion, that Commercialization of the Licensed Products is not commercially reasonable.

 

5.03                    Failure.  Any failure by Licensee to comply with the obligations set forth in this Article V shall be deemed to be a material breach for which Merck may exercise its termination rights under Article XII and any other available remedies at law or in equity.

 

ARTICLE VI – MANUFACTURING TECHNOLOGY TRANSFER

 

6.01                    Manufacturing Responsibility.  Licensee will be responsible for the Manufacturing of the Licensed Compounds and Licensed Product for use by Licensee, its Affiliates, and its sublicensees in the Field in the Territory.  Licensee shall have sole discretion over the Third Party manufacturer chosen by Licensee to conduct such Manufacture, and Licensee’s manufacture and supply agreement with such Third Party manufacturer shall not be subject to the provisions of Section 2.04.

 

ARTICLE VII - PAYMENTS; ROYALTIES AND REPORTS

 

7.01                    Consideration for License.  Subject to the terms and conditions of this Agreement and in consideration for the license granted to Licensee hereunder, Licensee shall pay to Merck a non-refundable, non-creditable, upfront payment of Seven Million U.S. Dollars ($7,000,000), which shall be due within thirty (30) days after the Effective Date.

 

7.02                    Milestone Payments.  Subject to the terms and conditions of this Agreement and in further consideration for the license granted herein, Licensee shall make each of the following one-time, non-refundable, non-creditable milestone payments to Merck based on attainment of the corresponding Development, regulatory and commercial milestones indicated below:

 

	
Milestone Payments

 
    

 

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Development Milestones

 
    
	
Development Milestone
    	
Milestone Payment Amount
    
	
[On a Licensed Product-by-Licensed Product basis] 
    	
1st Indication for a
   given Licensed
   Product
    	
Each Subsequent
   Indication for a
   given Licensed
   Product(s)

 
    
	
1.  Initiation* of the first Phase I Clinical   Trial for a Licensed Product

 
    	
[**]
    	
[**]
    
	
2. Initiation*   of the first Phase II Clinical Trial for a Licensed Product

 
    	
[**]
    	
[**]
    
	
3.  Initiation* of the first Phase III Clinical   Trial for a Licensed Product

 
    	
[**]
    	
[**]
    
	
4.  Filing and acceptance of the first NDA for   a Licensed Product in the United States

 
    	
[**]
    	
[**]
    
	
4.  Filing of the first application for   marketing authorization of a Licensed Product in the EU

 
    	
[**]
    	
[**]
    
	
5. Filing   of the first application for Marketing Authorization of a Licensed Product in   Japan.

 
    	
[**]
    	
[**]
    
	
6.  Granting of Marketing Authorization for a   Licensed Product in the U.S.

 
    	
[**]
    	
[**]
    
	
7.  Granting of Marketing Authorization ** for   a Licensed Product in the EU

 
    	
[**]
    	
[**]
    
	
8.  Granting of Marketing Authorization for a   Licensed Product in Japan

 
    	
[**]
    	
[**]
    
	
* Initiation   means first dosing of the first properly enrolled patient in the relevant   Clinical Trial.

 

** This   milestone requires granting of Marketing Authorization for a Licensed Product   for the relevant indication in any three (3) of the Major European   Countries. 

 
    
	
Sales Milestones

 
    
	
Sales Milestone
    	
Milestone Payment Amount
    
	
Total Net Sales of Licensed Products in the   Territory in a Calendar Year are equal to or greater than [**]
    	
[**]
    
	
Total Net Sales of Licensed Products in the   Territory in a Calendar Year are equal to or greater than [**] 
    	
[**]
    
	
Total Net Sales of Licensed Products in the   Territory in a Calendar Year are equal to or greater than [**] 
    	
[**]
    
				

 

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Licensee shall notify Merck in writing within ten (10) business days after the achievement of each such milestone event giving rise to a payment obligation under this Section and Licensee shall pay Merck the indicated amount no later than thirty (30) days after such achievement.

 

7.03                    Royalties.

 

(a)           Royalty Rates.  Subject to the terms and conditions of this Agreement, Licensee shall pay to Merck royalties on Net Sales of Licensed Product on a Licensed Product-by-Licensed Product basis in an amount equal to:

 

	
Net Sales of a Licensed   Product in the
   Territory During a Calendar Year

 
    	
Royalty
   Rate
    
	
Net Sales up to   $[**]

 
    	
[**]
    
	
Incremental net   sales above $[**] and up to $[**]

 
    	
[**]
    
	
Incremental Net   Sales above $[**]

 
    	
[**]
    

 

(b)           Term of Royalty Obligation.  Royalties on a given Licensed Product shall commence upon the First Commercial Sale of such Licensed Product in a particular country in the Territory and will continue until the later of (i) the expiration of the last to expire Valid Claim of a Compound Patent Right covering or claiming such Licensed Product (or the Licensed Compounds contained in, or comprising, such Licensed Product)  or (ii) the tenth (10th) anniversary of the date of the First Commercial Sale of such Licensed Product in such country.

 

(c)            Royalty Adjustments.  Notwithstanding Section 7.03(a), in the event that the sale of a Licensed Product in a country during the applicable royalty term pursuant to Section 7.03(b) with respect to such Licensed Product and such country, would not infringe a Valid Claim of a Compound Patent Right, then the royalty rate set forth in Section 7.03(a) shall be reduced by fifty percent (50%) with respect to Net Sales of such Licensed Product in such country.  If a Licensed Product is covered by Valid Claims of more than one Compound Patent Right, the royalty under this Section 7.03 shall be payable only once.

 

(d)   Third Party Licenses.  In the event that Licensee is required to obtain a license under any patents  from any Third Party(ies) in order to make, have made, use, offer to sell, sell or import the Licensed Compounds, (i) [**] of the royalties  actually paid under such Third Party patent licenses by Licensee in connection with the manufacture, use, sale or import, as applicable, of the Licensed Compound in a country for a Calendar Quarter shall be creditable against the royalty payments due Merck by Licensee with respect to the sale of such Licensed Compound in such country; provided, however, that in no event shall the royalties owed by Licensee to Merck for such Calendar Quarter in such country be reduced by more than [**] pursuant to this Section 7.03(d); or (ii) if no royalty is paid, or in addition to a royalty, a lump sum payment is made for such Third Party patent licenses, then [**] of the lump sum payment actually paid shall be creditable against the next milestone payment then due Merck under Section 7.02; provided, however, that in no event shall the aggregate payments to be creditable against milestone payments due Merck exceed [**].

 

7.04                    Reports; Payment of Royalty; Payment Exchange Rate and Currency Conversions.

 

(a)           Royalties Paid Quarterly.  Within forty-five (45) calendar days following the end of each Calendar Quarter, following the First Commercial Sale of a Licensed Product, Licensee shall furnish to Merck a written report for the Calendar Quarter showing the Net Sales of Licensed Product, on a Licensed Product-by-Licensed Product and country-by-country basis, sold by Licensee, its Affiliates and its sublicensees in the Territory during such Calendar Quarter and the royalties payable under this Agreement for such Calendar Quarter.  Such written report shall include the gross sales of each Licensed Product on a

 

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country-by-country basis, an itemized calculation of any deductions taken from such gross sales to arrive at Net Sales for the applicable Calendar Quarter and the calculation of the amount of royalty payment due on such Net Sales.  Simultaneously with the submission of the written report, Licensee shall pay to Merck, for the account of Licensee or the applicable Affiliate or sublicensee, as the case may be, a sum equal to the aggregate royalty due for such Calendar Quarter calculated in accordance with this Agreement.

 

(b)           Method of Payment.  All payments to be made by Licensee to Merck under this Agreement shall be paid by bank wire transfer in immediately available funds to such bank account as is designated in writing by Merck from time to time upon at least thirty (30) days prior written notice.  Royalty payments shall be made in United States dollars.  The rate of exchange to be used in any such conversion from the currency in the country where such Net Sales are made shall be the rate of exchange used by Licensee for reporting such sales for United States financial statement purposes.  If, due to restrictions or prohibitions imposed by national or international authority, payments cannot be made as aforesaid, the Parties shall consult with a view to finding a prompt and acceptable solution, and Licensee will make such payments in any manner as Merck may lawfully direct; provided, that Licensee shall not be obligated to incur any additional out-of-pocket expenses in connection with such payments nor to make any payment in violation of applicable law.  Notwithstanding the foregoing, if royalties in any country cannot be remitted to Merck for any reason within six (6) months after the end of the Calendar Quarter during which they are earned, then Licensee shall be obligated to deposit the royalties in a bank account in such country in the name of Merck.

 

(c)            Withholdings.  If applicable laws, rules or regulations require Licensee to withhold income or other similar taxes (“Taxes”), from the payments made by Licensee to Merck under this Agreement (“Agreement Payments”), then Licensee shall make such withholding payments and shall subtract the amount thereof from the Agreement Payments.  Licensee shall submit to Merck appropriate proof of payment of the withheld Taxes as well as the official receipts and other information reasonably requested by Merck in order for Merck to obtain a refund for any such Taxes within a reasonable period of time.  In addition, Licensee shall provide Merck reasonable information in its possession and shall otherwise provide reasonable assistance to Merck in order to allow Merck to obtain the benefit of any present or future treaty against double taxation which may apply to the Agreement Payments.

 

7.05                    Maintenance of Records; Audits.

 

(a)           Record Keeping by Licensee.  Licensee and its Affiliates shall keep complete and accurate records in sufficient detail to enable the royalties payable hereunder to be determined.  Upon thirty (30) days prior written notice from Merck, Licensee shall permit an independent certified public accounting firm of nationally recognized standing selected by Merck and reasonably acceptable to Licensee, at Merck’s expense, to have access during normal business hours to examine the pertinent books and records of Licensee, its Affiliates and/or sublicensees as may be reasonably necessary to verify the

 

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accuracy of the royalty reports hereunder.  The examination shall be limited to the pertinent books and records for twelve (12) month period ending not more than thirty-six (36) months prior to the date of such request.  An examination under this Section 7.05(a) shall not occur more than once in any Calendar Year; provided, that the foregoing limitation shall not prohibit Merck from conducting additional audits in the event that Merck should “have cause” to reasonably believe that this Agreement has been breached or that the initial audit was flawed on the basis of materials provided to the auditors.  Licensee may designate competitively sensitive information that such auditor may not disclose to Merck; provided, however, that such designation shall not encompass the auditor’s conclusions.  The accounting firm shall disclose to Merck only whether the royalty reports are correct or incorrect and the specific details concerning any discrepancies.  No other information shall be provided to Merck.

 

(b)           Underpayments/Overpayments.  If such accounting firm correctly concludes that additional royalties were owed during such period, Licensee shall pay such additional royalties within thirty (30) days after the date Merck delivers to Licensee such accounting firm’s written report so correctly concluding.  If such underpayment [**] and [**] of the sums correctly due Merck, then the fees charged by such accounting firm for the work associated with the underpayment audit shall be paid by Licensee.  Any overpayments by Licensee will be credited against future royalty obligations.

 

(c)            Record Keeping by Sublicensee.  Licensee shall include in each sublicense granted by it pursuant to this Agreement a provision requiring the sublicensee to make reports to Licensee, to keep and maintain records of sales made pursuant to such sublicense and to grant access to such records by Merck’s independent accountant to the same extent required of Licensee under this Agreement.

 

(d)           Confidentiality.  Merck shall treat all financial information subject to review under this Section 7.05, or under any sublicense agreement, in accordance with the confidentiality provisions of Article IX of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with Licensee obligating it to retain all such financial information in confidence pursuant to such confidentiality agreement.

 

(e)           Late Payments.  Any amount owed by Licensee to Merck under this Agreement that is not paid within the applicable time period set forth herein shall accrue interest at the rate of the one (1) month London Inter-Bank Offering Rate (“LIBOR”) plus [**] as set by the British Bankers Association as of the due date.

 

ARTICLE VIII - PATENTS

 

8.01                    Prosecution and Maintenance of Patents.  Subject to the last sentence of this Section 8.01, and except as set forth in Section 8.06, Merck agrees to prosecute and maintain [**] the Compound Patent Rights.  Merck shall keep Licensee promptly advised of such patent prosecution and maintenance.  Licensee shall have the sole right to determine which patents (including without limitation Compound Patent Rights) shall be listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (also known as the “Orange Book”)

 

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and submitted for patent term extension consideration in the United States, or any analogous or similar listing in the Territory, with respect to any Licensed Product.  In the event that Merck [**] takes material additional steps in connection with prosecution and maintenance of the Compound Patent Rights, such as appealing an examination decision or commencing an adversarial patent office proceeding or other material additional steps similar in nature to the preceding examples, [**].

 

8.02                    Option of Licensee to Prosecute and Maintain Patents.  Merck shall give notice to Licensee of any desire to cease prosecution and/or maintenance of the Compound Patent Rights and, in such case, shall permit Licensee to continue the prosecution or maintenance [**].

 

8.03                    Enforcement.  In the event that either Licensee or Merck becomes aware of any alleged or threatened commercially material infringement by a Third Party in a country in the Territory of any issued patent within the Compound Patent Rights (including without limitation any Paragraph IV certification under the Hatch-Waxman Act), it will notify the other Party in writing to that effect.  Licensee shall have the right, but not the obligation, to obtain a discontinuance of such infringement or bring suit against the Third Party infringer through counsel of its own choosing.  Licensee shall bear all the expenses of any suit brought by it.  Merck will reasonably cooperate with Licensee in any such suit or action and shall have the right to consult with Licensee and be represented by its own counsel at its own expense, but Licensee shall have sole authority regarding the prosecution, settlement, and appeal of such action.  Any recovery or damages derived from a suit shall be used first to reimburse Licensee for its documented out-of-pocket legal expenses relating to the suit, with any remaining amounts to be treated as Net Sales in the applicable country to which the suit or action relates, which Licensee shall retain net of any royalty owed to Merck pursuant to Section 7.03.  Licensee shall incur no liability to Merck as a consequence of such litigation or any unfavorable decision resulting therefrom, including any decision holding any of the Compound Patent Rights invalid or unenforceable.

 

8.04                    Infringement and Third Party Licenses.

 

(a)           Course of Action.  In the event that Licensee’s, its Affiliates’ or its sublicensees’ making, having made, importing, exporting, using, Manufacturing, having Manufactured Licensed Compounds or distributing, marketing, promoting, offering for sale or selling Licensed Product infringes, will infringe or is alleged by a Third Party to infringe, a claim of a patent that specifically covers the Licensed Compounds or their Manufacture, the Party becoming aware of same shall promptly notify the other.  The Parties shall thereafter attempt to agree upon a course of action that may include:  (i) modification of the Licensed Product or its use and Manufacture so as to be non-infringing; or (ii) obtaining a license or assignment from said Third Party.

 

(b)           Licensee Right to Negotiate.  In the event the Parties cannot agree on modifying the Licensed Product pursuant to Section 8.04(a), Licensee shall in the first instance have the right to negotiate with said Third Party for a suitable license or assignment.

 

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8.05                    Third Party Infringement Suit.  In the event that a Third Party sues Licensee alleging that Licensee’s, its Affiliates’ or its sublicensees’ making, having made, importing, exporting, using, Manufacturing, having Manufactured Licensed Compounds or distributing, marketing, promoting, offering for sale or selling Licensed Product infringes or will infringe a claim of a patent that specifically covers the Licensed Compounds or its manufacture, then Licensee shall, at its sole cost and expense, have the first right to elect to defend such suit during the period in which such suit is pending.

 

8.06     [**].  Notwithstanding anything to the contrary herein, the responsibility and expense of [**] will be transferred to the Licensee within thirty (30) days of the Effective Date, and Licensee shall take all steps reasonably necessary to assume responsibility for [**].  All costs and expenses associated with [**] and incurred after May 4, 2012 shall be the sole and exclusive responsibility of Licensee.  The responsibility and expense of [**] will be with the Licensee and all costs and expenses associated with [**] and incurred after May 4 2012 shall be the sole and exclusive responsibility of Licensee.  To the extent any of the foregoing expenses have been or will be paid by Merck, Licensee shall promptly reimburse Merck for any such expenses following Merck’s submission of invoices and receipts reflecting such payment.

 

ARTICLE IX- CONFIDENTIALITY AND PUBLICATION

 

9.01                    Confidentiality.

 

(a)           Nondisclosure Obligation.  Each of Merck and Licensee shall use any Proprietary Information received by it from the other Party only in accordance with this Agreement and shall not disclose to any Third Party any such Proprietary Information without the prior written consent of the other Party.  The foregoing obligations shall survive the expiration or termination of this Agreement for a period of ten (10) years.  These obligations shall not apply to Proprietary Information that:

 

(i)                    is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by the receiving Party’s written records;

 

(ii)                is at the time of disclosure, or thereafter becomes, published or otherwise part of the public domain without breach of this Agreement by the receiving Party;

 

(iii)            is subsequently disclosed to the receiving Party by a Third Party who has the right to make such disclosure, as documented by the receiving Party’s written records; and

 

(iv)            is independently developed by the receiving Party or its Affiliates and without the aid, use or application of any of the disclosing Party’s Proprietary Information, and such independent development can be documented by the receiving Party’s written records.

 

(b)           Disclosure to Agents.  Notwithstanding the provisions of Section 9.01(a) and subject to the other terms of this Agreement, each of Licensee and Merck shall have the right to disclose Proprietary Information to their respective sublicensees, agents, consultants, Affiliates or other Third Parties (collectively “Agents”) in accordance with this Section 9.01(b).  Such disclosure shall be limited only to those Agents directly involved in the Development, Manufacturing, marketing or promotion of Licensed Compounds or Licensed Product (or for such Agents to determine their interest in performing such activities) in accordance with this Agreement.   Any such Agents must agree in writing to be bound by confidentiality and non-use obligations essentially the same as, and no less restrictive than, those contained in this Agreement.

 

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(c)         Notwithstanding the foregoing, the following disclosures of Merck’s Confidential Information are permitted under the conditions stated:

 

(i)            Licensee may disclose Confidential Information to any institutional review board of any entity conducting Clinical Trials with Licensed Product or to any Regulatory Authority in order to obtain patents or to gain approval to conduct Clinical Trials or to market Licensed Product; provided, that such disclosure may be made only to the extent reasonably necessary to obtain such patents or authorizations; and

 

(ii)        Licensee may disclose such Confidential Information as is required to be disclosed by law, regulation, rule, act or order of any Regulatory Authority ; provided, that notice is promptly delivered to the other Party in order to provide an opportunity to seek a protective order or other similar order with respect to such Proprietary Information and thereafter the receiving Party discloses to the requesting entity only the minimum information required to be disclosed in order to comply with the request, whether or not a protective order or other similar order is obtained by the other Party.

 

9.02                    Return of Confidential Information.  Upon termination of this Agreement, the receiving Party will return all documents, and copies thereof, including those in the possession of the receiving Party’s Agents pursuant to Section 9.01(b), containing the disclosing Party’s Proprietary Information at any time upon the written request of the disclosing Party.  However, the receiving Party may retain one (1) copy of such documents in a secure location solely for the purposes of (a) determining its obligations hereunder, (b) complying with any applicable regulatory requirements, or (c) defending against any product liability claim.

 

9.03                    Breach of Confidentiality.  The Parties agree that the disclosure of the Disclosing Party’s Proprietary Information in violation of this Agreement may cause the Disclosing Party irreparable harm and that any breach or threatened breach of this Agreement by the Receiving Party entitles disclosing Party to seek injunctive relief, in addition to any other legal or equitable remedies available to it, in any court of competent jurisdiction.  For clarity, such disputes shall not be subject to Article XII.

 

9.04                    No Publicity.  A Party may not use the name of the other Party in any publicity or advertising and may not issue a press release or otherwise publicize or disclose any information related to the existence of this Agreement or the terms or conditions herein, except (a) on the advice of its counsel as required by law (e.g., any Securities and Exchange Commission filings and disclosures) and provided the Party who will be disclosing such information has consulted with the other Party to the extent feasible prior to such disclosure with respect to the substance of the disclosure; or (b) as consented to in advance by the other Party in writing.  The Parties shall agree on a form of initial press release that may be used by either Party on an ongoing basis to describe this Agreement.  Licensee shall provide Merck with reasonable advance written notice of any press release or other public disclosure of the results of any of its work on Licensed Product under this Agreement.

 

9.05                    Terms of Agreement.  Neither Party nor its Affiliates shall disclose any terms or conditions of this Agreement to any Third Party without the prior consent of the other Party, 

 

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except as follows: A Party and its Affiliates may disclose the terms or conditions of this Agreement (but not any other Proprietary Information, which may be disclosed only as described elsewhere in this Article IX), (a) on a need-to-know basis to its legal and financial advisors to the extent such disclosure is reasonably necessary, provided that such advisors are subject to confidentiality with regard to such information under an agreement or ethical obligation; (b) to a Third Party in connection with (i) a financing (or proposed financing) or an equity investment (or proposed investment) in such Party or its Affiliates, including to its shareholders and prospective shareholders, (ii) a merger, consolidation or similar transaction by such Party or its Affiliates, (iii) the sale of all or substantially all of the assets of such Party or its Affiliates, or (iv) in connection with a sale of the royalties or other rights of payments contained herein, provided that such Third Party executes a non-use and non-disclosure agreement that provides for substantially the same protection of such information as such disclosing Party owes under this Agreement with respect to Proprietary Information of the other Party; (c) to the United States Securities and Exchange Commission or any other securities exchange or governmental entity, including as required to make an initial or subsequent public offering, or (d) as otherwise required by law or regulation, provided that in the case of (c) and (d) the disclosing Party shall (x) if practicable, provide the other Party with reasonable advance notice of and an opportunity to comment on any such required disclosure, (y) if requested by such other Party, seek, or cooperate with such Party’s efforts to obtain, confidential treatment or a protective order with respect to any such disclosure to the extent available at such other Party’s expense, and (z) use good faith efforts to incorporate the comments of such other Party in any such disclosure or request for confidential treatment or protective order.

 

ARTICLE X- REPRESENTATIONS AND WARRANTIES

 

10.01          Representations, Warranties and Covenants of Each Party.  Each of Merck and Licensee hereby represents, warrants and covenants to the other Party hereto as follows:

 

(a)         it is a corporation duly organized and validly existing under the laws of the state or other jurisdiction of its incorporation;

 

(b)         the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action;

 

(c)          it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder;

 

(d)         the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions herein does not and will not conflict with or result in a breach of any of the terms and provisions of or constitute a default under (i) a loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) the provisions of its corporate charter or other operative documents or bylaws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound;

 

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(e)           except for the governmental and Marketing Authorizations required to market the Licensed Product in the Territory, the execution, delivery and performance of this Agreement by such Party do not require the consent, approval or authorization of, or notice, declaration, filing or registration with, any governmental or Regulatory Authority and the execution, delivery or performance of this Agreement will not violate any law, rule or regulation applicable to such Party;

 

(f)            this Agreement has been duly authorized, executed and delivered and constitutes such Party’s legal, valid and binding obligation enforceable against it in accordance with its terms subject, as to enforcement, to bankruptcy, insolvency, reorganization and other laws of general applicability relating to or affecting creditors’ rights and to the availability of particular remedies under general equity principles; and

 

(g)         it shall comply with all applicable laws and regulations relating to its activities under this Agreement.

 

10.02         Additional Licensee Representations, Warranties and Covenants.  Licensee hereby represents, warrants and covenants to Merck as follows:

 

(a)         during the Term it will not use in any capacity, in connection with any services to be performed under this Agreement, any individual who has been debarred pursuant to the United States Food, Drug and Cosmetic Act;

 

(b)           it has the capacity and resources to Develop Licensed Product and to Manufacture Licensed Compounds in accordance with the Development Plan.

 

10.03         Additional Merck Representations, Warranties and Covenants.  Merck hereby represents, warrants and covenants to Licensee as follows:

 

(a)           Merck has the full right, power and authority to (i) grant all of the right, title and interest in the licenses granted to Licensee under this Agreement and (ii) provide copies of the tangible embodiments of Merck Know-How and Product Registration Data in accordance with Article IV.

 

(b)           Merck is the sole and exclusive legal, beneficial and record owner of the existing Compound Patent Rights, Merck Know-How and Product Registration Data, free and clear of any liens, charges, encumbrances and rights of any Third Party (including any rights to royalties, commissions or similar obligations with respect thereto), contingent or otherwise;

 

(c)            [**]

 

10.04            No Inconsistent Agreements.  Neither Party has in effect, and after the Effective Date neither Party shall enter into, any oral or written agreement or arrangement that would be inconsistent with its obligations under this Agreement.

 

10.05            Representation by Legal Counsel.  Each Party hereto represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting of this Agreement.  In interpreting and applying the terms and 

 

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provisions of this Agreement, the Parties agree that no presumption shall exist or be implied against the Party that drafted such terms and provisions.

 

10.06            Disclaimer.  EXCEPT AS EXPRESSLY SET FORTH IN THIS ARTICLE X, THE LICENSED COMPOUND, LICENSED PRODUCT, COMPOUND PATENT RIGHTS AND MERCK KNOW-HOW 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 IMPLIED WARRANTY THAT THE USE OF THE MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY.

 

10.07            No Warranty.  EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY HERETO MAKES ANY REPRESENTATION AND EXTENDS NO WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED.  IN PARTICULAR, BUT WITHOUT LIMITATION, MERCK MAKES NO REPRESENTATION AND EXTENDS NO WARRANTY CONCERNING WHETHER THE LICENSED COMPOUND OR A LICENSED PRODUCT IS FIT FOR ANY PARTICULAR PURPOSE OR SAFE FOR HUMAN CONSUMPTION.

 

ARTICLE XI - INDEMNIFICATION AND LIMITATION ON LIABILITY

 

11.01            Indemnification by Licensee.  Licensee shall indemnify, defend and hold harmless Merck and its Affiliates, and each of its and their respective employees, officers, directors and agents (each, a “Merck Indemnified Party”) from and against any and all liability, loss, damage, cost, and expense (including reasonable attorneys’ fees), subject to the limitations in Section 11.05 (collectively, a “Liability”) that a Third Party may assert against a Merck Indemnified Party resulting from or arising out of (a) the development, Manufacture, promotion, distribution, use, marketing, sale or other disposition of the Licensed Product by Licensee, its Affiliates or sublicensees, (b) any breach by Licensee of any of its representations, warranties and covenants contained in Sections 10.01 and 10.02 herein, and (c) the negligence and/or willful misconduct of Licensee, its Affiliates or sublicensees.  Notwithstanding the foregoing, Licensee shall have no obligation under this Agreement to indemnify, defend or hold harmless any Merck Indemnified Party with respect to any Liabilities that result from the negligence or willful misconduct of Merck, Merck Indemnified Party or any of their respective employees, officers, directors or agents or that result from Merck’s breach of its obligations under this Agreement.

 

11.02            Indemnification by Merck.  Merck shall indemnify, defend and hold harmless Licensee and its Affiliates, and each of its and their respective employees, officers, directors and agents (each, a “Licensee Indemnified Party”) from and against any Liability that a third party may assert against a Licensee Indemnified Party resulting from or arising in connection with (a) any breach by Merck of any of its representations, warranties and covenants contained in Sections 10.01 and 10.03 herein and (b) the negligence and/or willful misconduct of Merck.  Notwithstanding the foregoing, Merck shall have no obligation under this Agreement to indemnify, defend or hold harmless any Licensee Indemnified Party with respect to any 

 

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Liabilities that result from the negligence or willful misconduct of Licensee, Licensee Indemnified Party or any of their respective employees, officers, directors or agents or that result from Licensee’s breach of its obligations under this Agreement.

 

11.03            Conditions to Indemnification.  The obligations of the indemnifying Party under Sections 11.01 and 11.02 are conditioned upon the delivery of written notice to the indemnifying Party of any potential Liability promptly after the indemnified Party becomes aware of such potential Liability.  The indemnifying Party shall have the right to assume the defense of any suit or claim related to the Liability if it has assumed responsibility for the suit or claim in writing;  however, if in the reasonable judgment of the indemnified Party, such suit or claim involves an issue or matter that could have a materially adverse effect on the business operations or assets of the indemnified Party, the indemnified Party may retain control of the defense or settlement thereof by providing written notice of such effect to the indemnifying Party, but in no event shall such action or notice be construed as a waiver of any indemnification rights that the indemnified Party may have at law or in equity.  If the indemnifying Party defends the suit or claim, the indemnified Party may participate in (but not control) the defense thereof at its sole cost and expense.  The foregoing notwithstanding, the Parties acknowledge and agree that failure of the indemnified Party to promptly notify the indemnifying Party of a potential Liability shall not constitute a waiver of, or result in the loss of, such Party’s right to indemnification under Section 11.01 or 11.02, as appropriate, except to the extent that the indemnifying Party’s rights, and/or its ability to defend against such Liability, are materially prejudiced by such failure to notify.

 

11.04            Settlements.  Neither Party may settle a claim or action related to a Liability without the consent of the other Party, and such consent shall not be unreasonably withheld, if such settlement would impose any monetary obligation on the other Party or require the other Party to submit to an injunction or otherwise limit the other Party’s rights under this Agreement.  Any payment made by a Party to settle any such claim or action shall be at its own cost and expense.

 

11.05            Limitation of Liability.  With respect to any claim by one Party against the other Party or its Related Parties arising out of the performance or failure of performance of the other Party under this Agreement, except for a claim based on a breach of Section 9.01, the Parties expressly agree that the liability of such Party and its Related Parties to the other Party for such breach shall be limited under this Agreement or otherwise at law or equity to direct damages only and in no event shall a Party be liable for indirect, incidental, punitive, exemplary or consequential damages.

 

11.06            Insurance.  At such time as Licensee or any of its Affiliates or sublicensee begins to sell or distribute Licensed Product, Licensee shall, at its own expense, procure and maintain product liability insurance in the amount of [**]. All such policies shall name Merck as an additional insured, and insurers will waive all rights of subrogation against Merck.  Upon Merck’s request, Licensee will promptly provide for itself and its sublicensees copies of certificates of insurance evidencing such coverages.  Licensee shall notify Merck not less than thirty (30) days in advance of any material change or cancellation of any policy.  Licensee shall continue to maintain such insurance in effect after the expiration or termination of this Agreement during any period in which Licensee or its sublicensee continues to make, have made, use, sell, offer to sell or import Product.  If any insurance is on a claims made basis, Licensee will maintain such 

 

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insurance for a period of not less than five (5) years after it has ceased all commercial sale, distribution or use of any Product.

 

ARTICLE XII- TERM AND TERMINATION

 

12.01            Term and Expiration.  This Agreement shall be effective as of the Effective Date and, unless terminated earlier by mutual written agreement of the Parties or pursuant to Sections 12.02 or 12.03 below, shall continue in effect on a country-by-country and Licensed Product-by-Licensed Product basis until the later of (a) the expiration of the last to expire Valid Claim of a Compound Patent Right covering or claiming such Licensed Product (or the Licensed Compounds contained in, or comprising, such Licensed Product), or (b) the tenth (10th) anniversary of the date of the First Commercial Sale of such Licensed Product in such country (the “Term”).  Upon expiration of this Agreement in its entirety, Licensee’s license pursuant to Section 2.01 shall become a fully paid-up, irrevocable, perpetual license, sublicensable without restriction.

 

12.02            Termination by Licensee.

 

(a)           Licensee’s Right to Terminate.   Notwithstanding anything contained herein to the contrary, beginning upon completion of the first Phase II Clinical Trial of a Licensed Product (meaning after data lock and initial analysis of the results), Licensee may terminate this Agreement in its entirety without cause by giving one hundred eighty (180) days advance written notice to Merck.  In the event of such termination, the rights and obligations hereunder shall terminate; provided, however, that any payment obligations due and owing as of the termination date shall continue.

 

(b)         Effect of Termination.  Notwithstanding anything contained herein to the contrary, following any termination of this Agreement in its entirety under Section 12.02(a), all rights and licenses granted to Licensee hereunder shall revert back to Merck pursuant to Section 12.05.

 

12.03            Termination for Cause.

 

(a)         Termination for Cause.  This Agreement may be terminated, in its entirety or on a country-by-country basis upon written notice by either Party at any time during the Term:

 

(i)             upon or after the breach of any material provision of this Agreement if the breaching Party has not cured such breach within sixty (60) days following receipt of written notice from the non-breaching Party requesting cure of the breach or, if such breach is not susceptible of cure within such sixty (60) day period, the breaching Party has not taken appropriate steps to commence such cure during such sixty (60)-day period and continued to diligently pursue such cure in a manner reasonably designed to effect such cure within a reasonable period of time thereafter (not to exceed one hundred eighty (180) days). Any right to terminate under this Section 12.03(a) shall be stayed and the cure period tolled in the event that, during any cure period, the Party alleged to have been in material breach shall have initiated dispute resolution in accordance with Article 

 

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XIII with respect to the alleged breach, which stay and tolling shall last so long as the allegedly breaching Party diligently and in good faith cooperates in the prompt resolution of such dispute resolution proceedings; or

 

(ii)         upon the filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings by or against the other Party, or upon an assignment of a substantial portion of the assets for the benefit of creditors by the other Party, or in the event a receiver or custodian is appointed for such Party’s business, or if a substantial portion of such Party’s business is subject to attachment or similar process; provided, however, that in the case of any involuntary bankruptcy proceeding, such right to terminate shall only become effective if the proceeding is not dismissed within sixty (60) days after the filing thereof.

 

(b)         Effect of Termination for Cause on License.

 

(i)             Termination by Licensee for Cause.  In the event this Agreement is properly terminated by Licensee under Section 12.03(a), Licensee’s license pursuant to Section 2.01 shall become perpetual and sublicenseable; provided that Licensee continues to make the payments to be made to Merck by Licensee pursuant to Article VII.

 

(ii)         Termination by Merck for Cause.  In the event this Agreement is terminated by Merck under Section 5.03, 12.03 and/or 14.01(b), the rights and license granted to Licensee under Section 2.01 of this Agreement shall terminate and all rights to the Licensed Compounds and Licensed Product shall revert to Merck pursuant to Section 12.05.

 

12.04            Effect of Termination Generally.  Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination, and the provisions of Sections 7.5, 12.02. 12.03, 12.04 and 12.05, and Articles IX, XI, XIII and XIV shall survive the expiration or termination of this Agreement.  Any expiration or early termination of this Agreement shall be without prejudice to the rights of either Party against the other accrued or accruing under this Agreement prior to termination, including the obligation to pay royalties for Licensed Product sold prior to such termination.

 

12.05            Licensed Product Reversion.  Upon termination of this Agreement in its entirety by Merck for any reason or by Licensee pursuant to Section 12.02, at Merck’s option and upon Merck’s written request, the following provisions shall apply:

 

(a)         Effective upon such termination, without further action by either Party, Merck shall have a worldwide, fully paid-up, royalty-free, sublicensable, exclusive and perpetual license from Licensee under any Licensee Know-How or Licensee Patent Rights existing at the time of termination and that is necessary or useful for the use, Development, Manufacture, or Commercialization of the Licensed Product that is then being Developed or Commercialized by Licensee.  Merck’s license under this Section 12.05(a) shall be limited solely to the right to Develop, make, have made, use, import, export, Commercialize, offer to sell and sell such Licensed Product in the Field and Territory.  

 

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Further, if any Licensee Patent Rights are licensed from a Third Party then Licensee shall not be required to grant the foregoing license if such license would require the payment of money by Licensee, unless Merck agrees to assume any such payment obligations.

 

(b)         Licensee shall reasonably cooperate with Merck at Merck’s expense in order to enable Merck to assume responsibility for the Development, Manufacture and/or Commercialization of all Licensed Products then being Developed, Manufactured or Commercialized by Licensee.  Such cooperation and assistance shall be provided in a timely manner, no to exceed six (6) months, and shall include without limitation:

 

(i)             Licensee shall transfer to Merck (or its nominee), at Merck’s expense, all INDs, Marketing Authorizations, drug approval applications for Marketing Authorizations, and all supporting documentation for such filings and applications, made or obtained by Licensee or its Affiliates or any of its sublicensees to the extent relating to Licensed Product then being Commercialized or in Development.

 

(ii)         Licensee shall assign to Merck all of its rights in any trademarks and shall transfer to Merck all of its rights in any domain names containing trademarks, in each case at Merck’s expense and only to the extent that such trademarks have actually been or are planned to be utilized by Licensee in connection with the Commercialization of Licensed Product in the Field.  Subject to any rights of Third Parties therein, any assignment or transfer to Merck pursuant to this Section 12.05(b)(ii) shall be royalty-free.

 

(iii)     Licensee shall transfer to Merck (or its nominee), at Merck’s expense, to the extent not previously provided, a copy of all Licensee Know-How in its possession or under its control relating to any Licensed Product then being Commercialized or in clinical Development by Licensee and reasonably necessary for its continued Development, Manufacture and/or Commercialization, including without limitation all information contained in Licensee’s regulatory and/or safety databases, all in the format then currently maintained by Licensee.

 

(iv)     Upon the request of Merck, Licensee shall use reasonable efforts to assign to Merck any Sublicense Agreements previously entered into by Licensee to the extent related to Licensed Product.

 

(v)         Upon the request of Merck, Licensee, its Affiliates and its sublicensees shall complete any Clinical Trials related to Licensed Product in the Field that (x) are being conducted under Licensee’s IND for Licensed Product and are ongoing as of the date this Agreement is terminated, and (y) for which it is not practicable to transfer responsibility for conducting such studies to Merck; provided, however, that Merck agrees to reimburse Licensee for all Development costs incurred by Licensee after termination in completing such studies.

 

(vi)     Upon the request of Merck, Licensee shall transfer to Merck, at a price to be agreed in good faith, that shall not be more than one hundred and ten percent (110%) of

 

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Licensee’s fully allocated Manufacturing cost for the Licensed Product, all quantities of Licensed Product in the possession of Licensee or its Affiliates (including, without limitation, clinical trial supplies and Licensed Product intended for commercial sale).

 

(vii) At Merck’s request, Licensee’s sublicensee shall transfer to Merck the items described in clauses (a) and (b) of Section 2.04.

 

(viii)At Merck’s request, Licensee shall promptly provide to Merck copies of all clinical trial, contract manufacturing, or service agreements entered into by Licensee or its Affiliates with respect to the Licensed Product.  At Merck’s request, Licensee shall promptly assign (or cause to be assigned), such agreements to Merck, to the extent such assignment is permitted under such agreement or, in the case that such agreements involve products other than the Licensed Product, to the extent that the portion of the agreement involving solely the Licensed Product can be assigned.  In the event that such an assignment is not permitted under a particular clinical trial, contract manufacturing, or service agreement, then Licensee shall reasonably cooperate (at Merck’s request) to assist Merck in obtaining the benefits of such agreement.

 

The Parties shall use Diligent Efforts to complete the transition of the Development, Manufacture and Commercialization of the Licensed Product from Licensee to Merck pursuant to this Section 12.05 in a prompt manner.

 

ARTICLE XIII– DISPUTE RESOLUTION

 

13.01            Informal Discussions.  Except as otherwise provided herein, in the event of any controversy or claim arising out of or relating to this Agreement, or the rights or obligations of the Parties hereunder, or the relationship between the Parties with respect to the Licensed Compounds or Licensed Product, the Parties shall first try to settle their differences amicably between themselves. Either Party may initiate such informal dispute resolution by sending written notice of the dispute to the other Party, and within thirty (30) days after such notice appropriate representatives of the Parties shall meet for attempted resolution by good faith negotiations.  If such representatives are unable to resolve promptly such disputed matter within the said thirty (30) days, either Party may refer the matter by written notice to the other to the appropriate therapy area Vice President of Merck Research Laboratories, or his designee, and the Chief Executive Officer of Licensee, or his designee, for discussion and resolution.  If such individuals or their designees are unable to resolve such dispute within thirty (30) days of such written notice, either Party may initiate arbitration proceedings in accordance with the provisions of this Article XIII.

 

13.02            Arbitration.  All disputes arising out of or relating to this Agreement, or the rights or obligations of the Parties hereunder, or relating in any way to the relationship between the Parties with respect to the Licensed Compounds or Licensed Product, shall be finally and exclusively settled by arbitration by a panel of three (3) arbitrators, provided such dispute is not an “Excluded Claim.”  As used in this Section, the phrase “Excluded Claim” shall mean a dispute, controversy or claim that concerns (a) the validity or infringement of a patent, trademark or copyright; or (b) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory.

 

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(a)           The arbitration proceeding shall be conducted under the Commercial Arbitration Rules of the American Arbitration Association (“AAA”) with such proceedings to be held in New York, New York, United States.  The arbitrators will apply the substantive law specified in Section 14.02.  In all cases, the arbitration proceedings shall be conducted in the English language, and all documents that are submitted in the proceeding shall be in the English language.  Judgment upon the award rendered by arbitration may be issued and enforced by any court having competent jurisdiction.

 

(b)           If a Party intends to begin an arbitration to resolve a dispute, such Party shall provide written notice to the other Party, informing the other Party of such intention and any statement of claim required under the applicable arbitration rules (as determined in accordance with Section 13.02(a)).  Within twenty (20) business days after its receipt of such notice, the other Party shall, by written notice to the Party initiating arbitration, add any additional issues to be resolved that would be considered mandatory counterclaims under New York law.  For clarity, the resolution of any disputes regarding such counterclaims shall be conducted in the same proceedings as the initial claims.

 

(c)            Within forty-five (45) days following the receipt of the notice of arbitration, the Party referring the matter to arbitration shall appoint an arbitrator and promptly notify the other Party of such appointment.  The other Party shall, upon receiving such notice, appoint a second arbitrator within twenty one (21) days, and the two (2) arbitrators shall, within fifteen (15) days of the appointment of the second arbitrator, agree on the appointment of a third arbitrator who will act with them and be the chairperson of the arbitration panel.  In the event that either Party shall fail to appoint an arbitrator within thirty (30) days after the commencement of the arbitration proceeding, the arbitrator shall be appointed by the AAA.  In the event of the failure of the two (2) arbitrators to agree within sixty (60) days after the commencement of the arbitration proceeding to appoint the chairperson, the chairperson shall also be appointed by the AAA.

 

(i)             All of the arbitrators shall have significant legal or business experience in pharmaceutical licensing matters.  The arbitrators shall not be employees, directors or shareholders of either Party or any of their Affiliates.

 

(ii)         Each Party shall have the right to be represented by counsel throughout the arbitration proceedings.

 

(iii)     To the extent possible, the arbitration hearings and award will be maintained in confidence.

 

(iv)       In any arbitration pursuant to this Agreement, the award or decision shall be rendered by a majority of the members of the panel provided for herein, with each member having one (1) vote.  The arbitrators shall render a written decision with their resolution of the dispute that shall set forth in reasonable detail the facts of the dispute and the reasons for their decision.  The decision of the arbitrators shall be final and non-appealable and binding on the Parties.

 

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13.03   Injunctive Relief.  By agreeing to arbitration, the Parties do not intend to deprive any competent court of such court’s jurisdiction to issue a pre-arbitral injunction, pre-arbitral attachment or other order in aid of the arbitration proceedings and the enforcement of any award or judgment. Without prejudice to such provisional remedies in aid of arbitration as may be available under the jurisdiction of a national court, the court of arbitration shall have full authority to grant provisional remedies and to award damages for failure of any Party to respect the court of arbitration’s order to that effect.

 

13.04   Expenses of Arbitration and Expert Determination.  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 arbitrators; provided, however, that the arbitrators shall be authorized to determine whether a Party is the prevailing Party, and if so, to award to that prevailing Party reimbursement for its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges and travel expenses).  Absent the filing of an application to correct or vacate the arbitration award as permitted by applicable law, each Party shall fully perform and satisfy the arbitration award within fifteen (15) days of the service of the award.

 

ARTICLE XIV- MISCELLANEOUS

 

14.01   Assignment/Change of Control.

 

(a)           Assignment.  Neither this Agreement nor any or all of the rights and obligations of a Party hereunder may be assigned, delegated, sold, transferred, sublicensed (except as otherwise provided herein) or otherwise disposed of, by operation of law or otherwise, to any Third Party without the prior written consent of the other Party, and any attempted assignment, delegation, sale, transfer, prohibited sublicense or other disposition, by operation of law or otherwise, of this Agreement or of any rights or obligations hereunder contrary to this Section 14.01 shall be a material breach of this Agreement by the attempting Party, and shall be void and without force or effect; provided, however, that either Party may, without such consent of such Party, assign this Agreement and its rights and obligations hereunder to an Affiliate or in connection with the transfer or sale of all or substantially all of its assets related to the division or the subject business, or in the event of its merger or consolidation or change in control or similar transaction.  This Agreement shall be binding upon, and inure to the benefit of, each Party, its Affiliates, and its permitted successors and assigns.  Each Party shall be responsible for the compliance by its Affiliates with the terms and conditions of this Agreement.

 

(b)           Change of Control at Licensee.  In the event that any Change of Control (as defined below) causes Licensee’s rights and obligations hereunder to pass to any Third Party, such Third Party shall, within sixty (60) days after the effective date of such Change of Control, notify Merck (the “Third Party Notice”) of its intentions with regard to the Development and Commercialization of the Licensed Product under this Agreement.  If the Third Party succeeding to Licensee’s rights and obligations under this Agreement decides it will not continue the Development and/or Commercialization of the Licensed

 

CONFIDENTIAL TREATMENT

 

31

 

Product, then Merck shall have the right to terminate this Agreement upon thirty (30) days written notice to Licensee, without any opportunity to cure; provided that, Merck exercises its right to terminate within one hundred eighty (180) days of receiving the Third Party Notice.  If the Third Party succeeding to Licensee’s rights and obligations under this Agreement decides to continue the  Development and Commercialization of the Licensed Product, then all of the rights and obligations of Licensee under this Agreement shall inure to such Third Party; provided, that for the immediate twelve (12) month period following such Change of Control, such Third Party shall follow substantially the same Development Plan and budget as was in effect prior to such Change of Control; and provided, further, that within such twelve (12) month period the Third Party successor shall submit to Merck a new Development  Plan  for the next succeeding twelve (12) month period, which shall not, without the prior written approval of Merck,  and such approval shall not be unreasonably withheld, materially differ from the Development Plan in effect prior to such Change of Control.

 

(c)            Definition of Change of Control.  As used in this Section 14.01 the term “Change of Control” shall mean (i) any merger, reorganization, consolidation or combination in which a Party to this Agreement is not the surviving corporation, or (ii) any “person” (within the meaning of Sections 13(d) and 14 d)(2) of the Securities Exchange Act of 1934), excluding Licensee and its Affiliates, is or becomes the beneficial owner, directly or indirectly, of securities of the Party representing 50% or more of either (a) the then-outstanding shares of common stock of the Party or its parent corporation, or (b) the combined voting power of the Party’s then-outstanding voting securities; or (iii) if individuals who as of the Effective Date constitute the Board of Directors of the Party or its parent corporation (the “Incumbent Board”) cease for any reason to constitute at least a majority of such Board of Directors; provided, however, that any individual becoming a director subsequent to the Effective Date whose election, or nomination for election by the Party’s shareholders, was approved by a vote of at least a majority of the directors then comprising the Incumbent Board shall be considered as though such individual were a member of the Incumbent Board, but excluding, for this purpose, any such individual whose initial assumption of office occurs as a result of an actual or threatened election contest with respect to the election or removal of directors or other actual or threatened solicitation of proxies or consents by or on behalf of a person other than the Incumbent Board; or (iv) approval by the shareholders of a Party of a complete liquidation or the complete dissolution of such Party.

 

14.02   Governing Law.  This Agreement shall be governed, interpreted and construed in accordance with the laws of the State of New York, without giving effect to its conflict of law principles.  Subject to the terms of this Agreement, all disputes under this Agreement shall be governed by binding arbitration pursuant to the mechanism set forth in Article XIII herein.

 

14.03   Waiver.  Any delay or failure in enforcing a Party’s rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, nor operate to bar the exercise or enforcement thereof at any time or times thereafter, excepting only as to an express written and signed waiver as to a particular matter for a particular period of time.

 

CONFIDENTIAL TREATMENT

 

32

 

 

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

 

14.05   Export Control.  This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States of America that may be imposed upon or related to Merck or Licensee from time to time by the government of the United States of America.  Furthermore, Licensee agrees that it will not export, directly or indirectly, any technical information acquired from Merck under this Agreement or any products using such technical information to any country for which the United States government or any agency thereof at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the Department of Commerce or other agency of the United States government when required by an applicable statute or regulation.

 

14.06   Entire Agreement; Amendment.  This Agreement, including the Exhibits and Schedules hereto and thereto, sets forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto and supersedes and terminates all prior agreements and understandings between the Parties with regard to the subject matter of this Agreement in the Territory.  There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth herein and therein.  No subsequent alteration, amendment, change, waiver or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.

 

14.07   Notices.  Any notice required or permitted to be given or sent under this Agreement shall be hand delivered or sent by express delivery service or certified or registered mail, postage prepaid, or by facsimile transmission (with written confirmation copy by registered first-class mail) to the Parties at the addresses and facsimile numbers indicated below.

 

	
 
    	
if to Licensee, to:
    	
 
    	
TESARO, Inc.

1000 Winter Street, Suite 3300

Waltham, MA 02451

Attention: Chief Financial Officer

Facsimile No.: (339)469.8966
    

 

CONFIDENTIAL TREATMENT

 

33

 

	
 
    	
And with a copy to (which copy shall not constitute notice)::
    	
 
    	
Attention: Asher M. Rubin

Hogan Lovells US LLP

100 International Drive, Suite 2000

Baltimore, MD 21202

Facsimile No.: (410)659-2701
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
if to Merck, to:
    	
 
    	
Merck Sharp & Dohme Corp.

One Merck Drive

P.O. Box 100

Whitehouse Station, NJ 08889-0100

Attention: Office of Secretary

Facsimile No.: (908)735-1246
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
and
    	
 
    	
Merck Sharp & Dohme Corp.

One Merck Drive

Attention: Chief Licensing Officer

P.O. Box 100, WS2A-30

Whitehouse Station, NJ 08889-0100

Facsimile: (908)735-1214
    

 

Any such notice shall be deemed to have been received on the earlier of the date actually received or the date five (5) days after the same was posted or sent.  Either Party may change its address or its facsimile number by giving the other Party written notice, delivered in accordance with this Section 14.07.

 

14.08   Force Majeure.  Failure of any Party to perform its obligations under this Agreement (except the obligation to make payments when properly due) shall not subject such Party to any liability or place them in breach of any term or condition of this Agreement to the other Party if such failure is due to any cause beyond the reasonable control of such non-performing Party (“Force Majeure”) Causes of non-performance constituting Force Majeure shall include, without limitation, acts of God, fire, explosion, flood, drought, war, riot, sabotage, embargo, strikes or other labor trouble, failure in whole or in part of suppliers to deliver on schedule materials, equipment or machinery, interruption of or delay in transportation, a national health emergency or compliance with any order or regulation of any government entity acting with color of right.  The Party affected shall promptly notify the other Party of the condition constituting Force Majeure as defined herein and shall exert reasonable efforts to eliminate, cure and overcome any such causes and to resume performance of its obligations with all possible speed; provided that nothing herein shall obligate a Party to settle on terms unsatisfactory to such Party any strike, lockout or other labor difficulty, any investigation or other proceeding by any public authority or any litigation by any Third Party.  If a condition constituting Force Majeure as defined herein exists for more than ninety (90) consecutive days, the Parties shall meet to negotiate a mutually satisfactory resolution to the problem, if practicable.  If the Parties cannot in good faith reach a satisfactory resolution to the problem within sixty (60) days of meeting, the matter shall be handled pursuant to the dispute resolution provisions of Article XIII herein.

 

CONFIDENTIAL TREATMENT

 

34

 

14.09   Severability.  If any provision of this Agreement is declared illegal, invalid or unenforceable by a court having competent jurisdiction, it is mutually agreed that this Agreement shall continue in accordance with its terms except for the part declared invalid or unenforceable by order of such court, provided, however, that in the event that the terms and conditions of this Agreement are materially altered, the Parties will, in good faith, renegotiate the terms and conditions of this Agreement to reasonably substitute such invalid or unenforceable provisions in light of the intent of this Agreement.

 

14.10   Counterparts.  This Agreement shall become binding when any one or more counterparts of it, individually or taken together, shall bear the signatures of each of the Parties hereto.  This Agreement may be executed in any number of counterparts, each of which shall be an original as against either Party whose signature appears thereon, but all of which taken together shall constitute but one and the same instrument.  A facsimile or a portable document format (PDF) copy of this Agreement, including the signature pages, will be deemed an original.

 

14.11   Captions.  The captions of this Agreement are solely for the convenience of reference and shall not affect its interpretation.

 

14.12   Further Actions.  Subject to any express limitations set forth herein with respect to a Party’s on-going assistance obligations, each Party agrees to execute, acknowledge and deliver such further instruments, and to do all other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

 

[Signature page follows]

 

CONFIDENTIAL TREATMENT

 

35

 

 

 

IN WITNESS WHEREOF, this Agreement has been made effective by the duly authorized representatives of the Parties as of the Effective Date.

 

 

	
MERCK SHARP & DOHME CORP.
    	
 
    	
TESARO, INC.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/
    	
Barbara Yanni
    	
 
    	
 
    	
By:
    	
/s/
    	
Leon O. Moulder Jr.
    	
 
    
	
 
    	
Barbara Yanni
    	
 
    	
 
    	
Leon O. Moulder Jr.
    
	
 
    	
VP and Chief Licensing Officer
    	
 
    	
 
    	
Chief Executive Officer
    
	
 
    	
 
    	
 
    
	
Date:
    	
22 May 2012
    	
 
    	
 
    	
Date:
    	
22 May 2012
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
By:
    	
/s/
    	
Mary Lynne Hedley
    	
 
    
	
 
    	
 
    	
 
    	
Mary Lynne Hedley, Ph.D.
    
	
 
    	
 
    	
 
    	
President and Chief Scientific Officer
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
Date:
    	
22 May 2012
    	
 
    
											

 

 

Signature Page to License Agreement

CONFIDENTIAL TREATMENT

 

 

 

Schedule 1.08

 

 

Patent schedule for MK-4827 and MK-2512

 

(1) IRT-ONC-0121Y: Amide substituted indazole and benzotriazole derivatives as poly(ADP-ribose)polymerase(PARP) inhibitors

 

	
Country
    	
 
    	
Application Number
    	
 
    	
Filing Date
    	
 
    	
Status
    	
 
    	
Patent Number
    	
 
    	
Grant Date
    
	
Australia
    	
 
    	
2007232297
    	
 
    	
02 April 2007
    	
 
    	
Pending
    	
 
    	
 
    	
 
    	
 
    
	
Canada
    	
 
    	
2647545
    	
 
    	
02 April 2007
    	
 
    	
Pending
    	
 
    	
 
    	
 
    	
 
    
	
China P.R.
    	
 
    	
200780012001.6
    	
 
    	
02 April 2007
    	
 
    	
Pending
    	
 
    	
 
    	
 
    	
 
    
	
European Patent Convention
    	
 
    	
07733600.6
    	
 
    	
02 April 2007
    	
 
    	
Pending
    	
 
    	
 
    	
 
    	
 
    
	
India
    	
 
    	
8150/DELNP/08
    	
 
    	
02 April 2007
    	
 
    	
Pending
    	
 
    	
 
    	
 
    	
 
    
	
Japan
    	
 
    	
2009-503667
    	
 
    	
02 April 2007
    	
 
    	
Granted
    	
 
    	
4611441
    	
 
    	
22 October 2010
    
	
United States
    	
 
    	
13/091427*
    	
 
    	
21 April 2011
    	
 
    	
Pending
    	
 
    	
 
    	
 
    	
 
    

* Continuation application.  Current projected expiry date: 2 April 2027 not including term disclaimer or patent term extension, if any.

 

(2) IRT-ONC-0121Y2:  Amide substituted indazoles as poly(ADP-ribose)polymerase(PARP) inhibitors

 

	
Country
     	
 
     	
Application Number
     	
 
     	
Filing Date
     	
 
     	
Status
     	
 
     	
Patent Number
     	
 
     	
Grant Date
     
	
Albania
     	
 
     	
AL/P/2011/3701
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Algeria
     	
 
     	
090395
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Argentina
     	
 
     	
P080100061
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Armenia
     	
 
     	
200970674
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
016079
     	
 
     	
30 January 2012
     
	
Australia
     	
 
     	
2008204380
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Austria
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Azerbaijan
     	
 
     	
200970674
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
016079
     	
 
     	
30 January 2012
     
	
Barbados
     	
 
     	
2001/1480
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Belarus
     	
 
     	
200970674
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
016079
     	
 
     	
30 January 2012
     
	
Belgium
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Belize
     	
 
     	
587.09
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
587.09
     	
 
     	
05 March 2010
     

 

CONFIDENTIAL TREATMENT

 

 

	
Country
     	
 
     	
Application Number
     	
 
     	
Filing Date
     	
 
     	
Status
     	
 
     	
Patent Number
     	
 
     	
Grant Date
     
	
Bermuda
     	
 
     	
418EP
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Bosnia-Herzegovina
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Brazil
     	
 
     	
PI0806245-5
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Bulgaria
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Canada
     	
 
     	
2674436
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Chile
     	
 
     	
46-08
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
China P.R.
     	
 
     	
200880001926.5
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Colombia
     	
 
     	
09068415
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Costa Rica
     	
 
     	
PCT/GB2008/050018
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Croatia
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Cyprus
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Czech Republic
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Denmark
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Dominican Republic
     	
 
     	
P2009-0170
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Ecuador
     	
 
     	
SP-09-9484
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Egypt
     	
 
     	
PCT1065/2009
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
El Salvador
     	
 
     	
2009003321
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
20090008141
     	
 
     	
14 February 2011
     
	
Estonia
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Eurasian Patent Convention
     	
 
     	
200970674
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
016079
     	
 
     	
30 January 2012
     
	
European Patent Convention
     	
 
     	
11157369.7
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Finland
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
France
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Georgia
     	
 
     	
AP2008011413
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
P5337
     	
 
     	
25 November 2011
     
	
Germany
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
602008005711.9-08
     	
 
     	
23 March 2011
     
	
Great Britain
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Greece
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Guatemala
     	
 
     	
A-2009-00190
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     

 

CONFIDENTIAL TREATMENT

 

 

 

	
Country
     	
 
     	
Application Number
     	
 
     	
Filing Date
     	
 
     	
Status
     	
 
     	
Patent Number
     	
 
     	
Grant Date
     
	
Gulf Cooperation Council
     	
 
     	
2008/9897
     	
 
     	
05 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Honduras
     	
 
     	
2009-001260
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Hong Kong
     	
 
     	
09110676.1
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
1131137
     	
 
     	
09 December 2011
     
	
Hong Kong
     	
 
     	
11108534.3
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Hungary
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Iceland
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
India
     	
 
     	
4674/DELNP/2009
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Indonesia
     	
 
     	
W00200901818
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
0500443
     	
 
     	
10 February 2012
     
	
Ireland
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Israel
     	
 
     	
199264
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Italy
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Japan
     	
 
     	
2009-545240
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
4611444
     	
 
     	
22 October 2010
     
	
Kazakhstan
     	
 
     	
200970674
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
016079
     	
 
     	
30 January 2012
     
	
Korea South
     	
 
     	
10-2009-7014520
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Kyrgyzstan
     	
 
     	
200970674
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
016079
     	
 
     	
30 January 2012
     
	
Latvia
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Lebanon
     	
 
     	
236
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
8156
     	
 
     	
22 September 2008
     
	
Lithuania
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Luxembourg
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Macao
     	
 
     	
Not yet available
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Macedonia
     	
 
     	
P-2011/142
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Malaysia
     	
 
     	
PI 20092876
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Malta
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Mexico
     	
 
     	
MX/a/2009/007200
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
277664
     	
 
     	
29 July 2010
     
	
Moldova
     	
 
     	
200970674
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
016079
     	
 
     	
30 January 2012
     
	
Mongolia
     	
 
     	
4314
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
3334
     	
 
     	
25 October 2009
     
	
Morocco
     	
 
     	
PV32111
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
31554
     	
 
     	
02 August 2010
     

 

CONFIDENTIAL TREATMENT

 

 

	
Country
     	
 
     	
Application Number
     	
 
     	
Filing Date
     	
 
     	
Status
     	
 
     	
Patent Number
     	
 
     	
Grant Date
     
	
Netherlands
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
New Zealand
     	
 
     	
578256
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Nicaragua
     	
 
     	
2009-0135
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Norway
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Pakistan
     	
 
     	
20/2008
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Peru
     	
 
     	
97
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
not yet known
     	
 
     	
29 February 2012
     
	
Philippines
     	
 
     	
1-2009-501286
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Poland
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Portugal
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Romania
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Russian Federation
     	
 
     	
200970674
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
016079
     	
 
     	
30 January 2012
     
	
Serbia
     	
 
     	
P-236/2011
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
51780
     	
 
     	
23 March 2011
     
	
Singapore
     	
 
     	
200904280-5
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Slovak Republic
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Slovenia
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
South Africa
     	
 
     	
2009/03898
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2009/03898
     	
 
     	
28 April 2010
     
	
Spain
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Sweden
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Switzerland
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Taiwan
     	
 
     	
097100730
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Tajikistan
     	
 
     	
200970674
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
016079
     	
 
     	
30 January 2012
     
	
Thailand
     	
 
     	
0801000088
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Trinidad
     	
 
     	
TT/A/2009/00132
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Tunisia
     	
 
     	
TN2009/0286
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Turkey
     	
 
     	
08702101.0
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
2109608
     	
 
     	
23 March 2011
     
	
Turkmenistan
     	
 
     	
200970674
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
016079
     	
 
     	
30 January 2012
     
	
Ukraine
     	
 
     	
2009 08335
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
United States
     	
 
     	
12/006993**
     	
 
     	
08 January 2008
     	
 
     	
Granted
     	
 
     	
8071623
     	
 
     	
06 December 2011
     

 

CONFIDENTIAL TREATMENT

 

 

 

	
Country
     	
 
     	
Application Number
     	
 
     	
Filing Date
     	
 
     	
Status
     	
 
     	
Patent Number
     	
 
     	
Grant Date
     
	
Venezuela
     	
 
     	
2008-000029
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Vietnam
     	
 
     	
1-2009-01655
     	
 
     	
08 January 2008
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     

 

 

 

** Current projected patent expiry: 22 March 2030 not including terminal disclaimer.  Terminal disclaimer was filed against US Appl. No. 13/091427, which is a continuation of US Appl. No. 12/225857 and currently pending.  The ‘857 application was filed 2 April 2007 and abandoned.

 

(3) TER-ONC-1729: Pharmaceutically acceptable salts of 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide

 

	
Country
     	
 
     	
Application Number
     	
 
     	
Filing Date
     	
 
     	
Status
     	
 
     	
Patent Number
     	
 
     	
Grant Date
     
	
Australia
     	
 
     	
2009203598
     	
 
     	
08 January 2009
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Brazil
     	
 
     	
PI0906020-0
     	
 
     	
08 January 2009
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Canada
     	
 
     	
2711491
     	
 
     	
08 January 2009
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
China P.R.
     	
 
     	
200980101861.6
     	
 
     	
08 January 2009
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
European Patent Convention
     	
 
     	
09700579.7
     	
 
     	
08 January 2009
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
India
     	
 
     	
4920/DELNP/2010
     	
 
     	
08 January 2009
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Israel
     	
 
     	
206201
     	
 
     	
08 January 2009
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Japan
     	
 
     	
2010-541101
     	
 
     	
08 January 2009
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Korea South
     	
 
     	
10-2010-7015011
     	
 
     	
08 January 2009
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Mexico
     	
 
     	
MX/a/2010/006593
     	
 
     	
08 January 2009
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
New Zealand
     	
 
     	
586675
     	
 
     	
08 January 2009
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Russian Federation
     	
 
     	
2010133241
     	
 
     	
08 January 2009
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
South Africa
     	
 
     	
2010/03902
     	
 
     	
08 January 2009
     	
 
     	
Granted
     	
 
     	
2010/03902
     	
 
     	
23 February 2011
     
	
United States
     	
 
     	
12/811922
     	
 
     	
08 January 2009
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     

 

 

(4) IRT-ONC-0129: Pyridinone and pyridazinone derivatives as inhibitors of poly(ADP-ribose)polymerase (PARP)

 

	
Country
     	
 
     	
Application Number
     	
 
     	
Filing Date
     	
 
     	
Status
     	
 
     	
Patent Number
     	
 
     	
Grant Date
     
	
Australia
     	
 
     	
2007266836
     	
 
     	
25 May 2007
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Brazil
     	
 
     	
PI0711741-8
     	
 
     	
25 May 2007
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Canada
     	
 
     	
2653529
     	
 
     	
25 May 2007
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
China P.R.
     	
 
     	
200780020136.7
     	
 
     	
25 May 2007
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     

 

CONFIDENTIAL TREATMENT

 

 

	
Country
     	
 
     	
Application Number
     	
 
     	
Filing Date
     	
 
     	
Status
     	
 
     	
Patent Number
     	
 
     	
Grant Date
     
	
European Patent Convention
     	
 
     	
07733716.0
     	
 
     	
25 May 2007
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
India
     	
 
     	
9794/DELNP/2008
     	
 
     	
25 May 2007
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Israel
     	
 
     	
195113
     	
 
     	
25 May 2007
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Japan
     	
 
     	
2009-512681
     	
 
     	
25 May 2007
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Korea South
     	
 
     	
10-2008-7029132
     	
 
     	
25 May 2007
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Mexico
     	
 
     	
MX/a/2008/015014
     	
 
     	
25 May 2007
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
New Zealand
     	
 
     	
572815
     	
 
     	
25 May 2007
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Norway
     	
 
     	
2008 5397
     	
 
     	
25 May 2007
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
Russian Federation
     	
 
     	
2008152824
     	
 
     	
25 May 2007
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     
	
South Africa
     	
 
     	
2008/09238
     	
 
     	
25 May 2007
     	
 
     	
Granted
     	
 
     	
2008/09238
     	
 
     	
30 December 2009
     
	
United States
     	
 
     	
12/227513
     	
 
     	
25 May 2007
     	
 
     	
Pending
     	
 
     	
 
     	
 
     	
 
     

 

(5) IRT-ONC-0152: Pyridazinone derivatives as PARP inhibitors

 

	
Country
    	
 
    	
Application Number
    	
 
    	
Filing Date
    	
 
    	
Status
    	
 
    
	
Australia
    	
 
    	
2008322676
    	
 
    	
14 November 2008
    	
 
    	
Pending
    	
 
    
	
Brazil
    	
 
    	
PI0820236-2
    	
 
    	
14 November 2008
    	
 
    	
Pending
    	
 
    
	
Canada
    	
 
    	
2704714
    	
 
    	
14 November 2008
    	
 
    	
Pending
    	
 
    
	
China P.R.
    	
 
    	
200880115590.5
    	
 
    	
14 November 2008
    	
 
    	
Pending
    	
 
    
	
European Patent Convention
    	
 
    	
08850429.5
    	
 
    	
14 November 2008
    	
 
    	
Pending
    	
 
    
	
India
    	
 
    	
2638/CHENP/2010
    	
 
    	
14 November 2008
    	
 
    	
Pending
    	
 
    
	
Israel
    	
 
    	
205142
    	
 
    	
14 November 2008
    	
 
    	
Pending
    	
 
    
	
Japan
    	
 
    	
2010-533666
    	
 
    	
14 November 2008
    	
 
    	
Pending
    	
 
    
	
Korea South
    	
 
    	
10-2010-7013113
    	
 
    	
14 November 2008
    	
 
    	
Pending
    	
 
    
	
Mexico
    	
 
    	
MX/a/2010/005070
    	
 
    	
14 November 2008
    	
 
    	
Pending
    	
 
    
	
New Zealand
    	
 
    	
585395
    	
 
    	
14 November 2008
    	
 
    	
Pending
    	
 
    
	
Russian Federation
    	
 
    	
2010123874
    	
 
    	
14 November 2008
    	
 
    	
Pending
    	
 
    
	
South Africa
    	
 
    	
2010/02466
    	
 
    	
14 November 2008
    	
 
    	
Pending
    	
 
    
	
United States
    	
 
    	
12/739262
    	
 
    	
14 November 2008
    	
 
    	
Pending
    	
 
    

 

[**]

 

CONFIDENTIAL TREATMENT

 

 

 

Schedule 1.25

[**]

 

CONFIDENTIAL TREATMENT

 

 

Schedule 4.01-A

 

[**]

 

CONFIDENTIAL TREATMENT

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00205-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00205-of-00352.parquet"}]]