DEVELOPMENT AND INITIAL SUPPLY AGREEMENT

Exhibit 10.20

 

Portions of this document have been redacted pursuant to a Request for Confidential Treatment.

Redacted portions are indicated with the notation “[*****]”

 

DEVELOPMENT

AND

INITIAL SUPPLY

AGREEMENT

 

This Agreement is made and entered into on this 19th day of November 2003

 

 

(hereinafter referred to as “ BioMarin ”; of the one part)

 

 

(hereinafter referred to as “ Epro ”; of the other part)

 

BioMarin and Epro hereinafter sometimes individually referred to as “ Party ” and collectively as “ Parties ”.

 

SECTION 1—PREAMBLE

 

WHEREAS, BioMarin is a well-known developer of pharmaceutical products for rare diseases;

 

WHEREAS, BioMarin is interested in developing Tetrahydrobiopterin for the treatment of genetic diseases such as phenylketonuria (PKU);

 

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WHEREAS, Epro has expertise and know-how in process development, formulation and manufacturing of reduced folate and pterins and cGMP production of active pharmaceutical ingredients;

 

WHEREAS the Parties have signed a term sheet, that is attached to this Agreement as Schedule 1 .

 

NOW, THEREFORE, IN CONSIDERATION OF THE MUTUAL COVENANTS AND AGREEMENTS HEREIN CONTAINED, IT IS HEREBY AGREED BY THE PARTIES HERETO AS FOLLOWS:

 

SECTION 2—DEFINITIONS

 

In this Agreement the following terms, whether used in the singular or plural, shall, as used herein, have the following respective meanings:

 

2.1 “ Affiliates ” means any individual, company, partnership or other entity, which directly or indirectly, at present or in the future, controls, is controlled by or is under common control with a Party.

 

2.2 “ Agreement ” means this Development and Initial Supply Agreement.

 

2.3 “ Arbitration Request ” has the meaning ascribed thereto in Section 17.2 .

 

2.4 “ Batch Records ” means, for each separate and distinct quantity of Product designated by a batch number, the production protocols and all amendments thereto, to be agreed upon between the Parties and such other documentation related to the manufacture of the batch as reasonably requested by BioMarin.

 

2.5 “ BioMarin Field of Use ” means use of the Product in the field of single gene disorders, including the indication of phenylketonuria (“ PKU ”). Specifically excluded is any single-gene disorder based on mutation or deletion of the nitric oxide synthase gene.

 

2.6 “ BioMarin Proprietary Information ” means all Intellectual Property Rights of BioMarin developed outside the scope of the Project, whether developed before or after the date of this Agreement.

 

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2.7 “ BioMarin Technology ” means any and all current and future BioMarin Proprietary Information that is disclosed, either directly or indirectly, by BioMarin to Epro in the course of performing the Project or that is used in the manufacture of Product.

 

2.8 “ Certificate of Analysis ” (“ CoA ”) shall mean the certificate of analysis for each batch of Product delivered to BioMarin.

 

2.9 “ cGMP ” means current good manufacturing practices and general biological products standards as promulgated under the US Federal Food Drug and Cosmetic Act at 21 CFR and the EEC Guide to Good Manufacturing Practices for Medical Products (Vol. IV—rules governing medical products in the European Community 1989) in the most recent version.

 

2.10 “ Claims ” has the meaning ascribed thereto in Section 11.2 .

 

2.11 “ Commercial Supply and License Agreement ” has the meaning ascribed thereto in Section 5.3 .

 

2.12 “ Costs ” means the provable costs for the Project, which shall include the costs for the lab and the manufacturing unit as well as the costs of raw materials, filters, resins, external testing, out of pocket expenses, transportation and insurance of Product, brokers fees, customs duties, import duties, excise taxes, and other taxes directly related to the Product.

 

2.13 “ Dispute ” has the meaning ascribed thereto in Section 17.1 .

 

2.14 “ Documents ” means the Specifications, Batch Records, Certificate of Analysis containing the outcome of the tests on the final bulk Product, Manufacturing Instructions, and the chemistry manufacturing and control (CMC) part of BioMarin’s investigational new drug (IND) amendment insofar as related to Epro’ activities under this Agreement, and all amendments thereto, to be agreed upon between the Parties.

 

2.15 “ Epro Field of Use ” means use of the Product in the field of endothelial dysfunctions using modulation of nitric oxide synthase (“ NOS ”).

 

2.16 “ Epro Proprietary Information ” means all Intellectual Property Rights of Epro developed outside the scope of the Project, whether developed before or after the date of this Agreement, which explicitly shall include the already existing know-how for the stabilization of the Product.

 

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2.17 “ Epro Technology ” means any and all current and future Epro Proprietary Information that is disclosed, either directly or indirectly, by Epro to BioMarin in the course of performing the Project or that is used in the manufacture of Product.

 

2.18 “ Force Majeure ” has the meaning ascribed thereto in Section 19.1 .

 

2.19 “ Intellectual Property Rights ” means, whether or not protected or protectible under any particular law, all patents, patent applications, patentable subject matter, copyrights, copyrightable subject matter, ideas, inventions, discoveries, devices, designs, apparatuses, practices, processes, methods, products, cell lines, samples, trade secrets, technology, know-how, software, hardware, improvements (and the goodwill pertaining thereto).

 

2.20 “ Manufacturing Instructions ” means the protocols for manufacturing the Product and all amendments thereto, to be developed pursuant to this Agreement and to be agreed upon between the Parties.

 

2.21 “ Parties ” means Epro and BioMarin collectively.

 

2.22 “ Party ” means either Epro or BioMarin, as appropriate.

 

2.23 “ Process ” means the processes to be developed by Epro for manufacturing of the Product and shall include further development of a chemically stable form of the Product, and development of analytical methods for in-process control and final Product release.

 

2.24 “ Product ” means (6R)-5,6,7,8-Tetrahydro-L-biopterin dihydrochloride (Tetrahydrobiopterin, BH4) intended for use as an active pharmaceutical ingredient.

 

2.25 “ Project ” means the development of the Process and the initial manufacturing of a chemically stable form of the Product for preclinical and clinical trials using the Process, as further described in this Agreement and in Schedule 2 annexed hereto and all amendments thereto, as may be agreed upon between the Parties.

 

2.26 “ Project Intellectual Property Rights ” means all Intellectual Property Rights, including but not limited to improvements specifically related to the Process discovered or developed by Epro in the course of performing the Project and manufacturing the Product.

 

2.27 “ Project Manager ” means the individual of each of the Parties responsible for the scientific and technical components of the Project as well as for controlling Costs,

 

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sufficiently dedicated to the Project in order for each of the Parties to carry out the Project using its best reasonable efforts.

 

2.28 “ Proprietary Information ” has the meaning ascribed to it in Section 13.1 .

 

2.29 “ Quality Agreement ” has the meaning ascribed thereto in Section 5.2 .

 

2.30 “ Release ” means that, after Product has been manufactured, the Product meets the relevant Specifications and the Process used for manufacturing the Product was in compliance with cGMP as determined by Epro’s quality assurance department, in addition to approval of receipt of API by BioMarin.

 

2.31 “ Specifications ” means the specifications, technical data and/or formulae of the Product, as further described in Schedule 3 annexed hereto and being a part hereof, and all amendments thereto, to be agreed upon between the Parties.

 

2.32 “ Term Sheet ” means the Term Sheet executed by the Parties and attached hereto as Schedule 1 .

 

SECTION 3—OBJECTIVES AND OBLIGATIONS OF THE PARTIES

 

The objective of the Project is to develop and optimize synthetic routes for the commercial scale manufacture of the Product for use as an active pharmaceutical ingredient in the treatment of indications in the BioMarin and Epro Fields of Use. The Parties hereby acknowledge and agree that there is no guarantee that the objective will be achieved, that the Product will be commercially exploitable or profitable or that the Product will be delivered in the time frames provided in this Agreement.

 

Epro will use its best efforts to deliver Product in the quantities and in the time frames specified in Schedule 2 . Epro will place a high priority on carrying out this Project as reflected by the resources and scheduling that are dedicated to this Project.

 

BioMarin will use its best efforts to provide Epro with the assistance and support related to the Project specified in this Agreement. BioMarin will place a high priority on carrying out this Project as reflected by the resources and scheduling that are dedicated to this Project.

 

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In the event that, despite Epro’s best efforts, it is unable to provide Product as specified in Schedule 2 , BioMarin will have the right to terminate this Agreement pursuant to Section 14.4 .

 

SECTION 4—DEVELOPMENT OF PRODUCT

 

4.1 Epro has developed special know-how in the area of stabilizing folates as well as procedures for the stabilization of the Product. Epro will expand this know-how and bear the costs of the development necessary to file a first patent application.

 

4.2 Epro will use its best efforts to expand its know-how to develop and optimize the Process for manufacturing the Product via new economic synthetic routes according to the proposals in Schedule 4 as well as include its existing and further explored know-how on the stabilization of the Product. The Costs related to development and manufacture of the Product will be shared between the Parties as set forth in Section 6 .

 

4.3 The ownership and protection of the Intellectual Property related to the Product and Program, as between the Parties, will be governed by Section 10 .

 

SECTION 5—MANUFACTURING OF PRODUCT

 

5.1 Epro shall use its best efforts to manufacture the Product in the quantities and at the times specified in Schedule 2 , attached hereto. The Product shall be manufactured in accordance with the Specifications and for clinical uses under cGMP.

 

5.2 All manufacturing activities related to the Project will be conducted in accordance with the terms of this Agreement and a Quality Agreement to be negotiated by the Parties (the “ Quality Agreement ”). The Quality Agreement will include the detailed requirements related to the manufacture and Release of the Product, including, without limitation, the procedures and requirements related to the Documents, Manufacturing Instructions, Batch Records and Certificate of Analysis. The Parties will use their best efforts to finalize the Quality Agreement within sixty (60) days after the date of this Agreement. If the Parties are unable to finalize the Quality Agreement, senior management of each Party will discuss all open issues and, if still unable to finalize the Quality Agreement, will participate, in good faith, in commercial mediation to resolve any open issues. The cost of such mediation shall be split equally between the Parties.

 

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5.3 In anticipation of the possibility that, in BioMarin’s discretion, BioMarin determines that the clinical trials related to the Product in one or more indications in the BioMarin Field of Use are successful and that BioMarin wishes to proceed with commercialization of the Product, or in the event that Epro develops the Product for an indication in the Epro Field of Use, or the Parties develop an alternate commercial application for the Product or the Project Intellectual Property Rights, the Parties will execute a Commercial Supply and License Agreement (the “ Commercial Supply and License Agreement ”) that the Parties expect will supersede this Agreement, include the development terms contained herein and the additional terms set forth in the Term Sheet related to commercialization, the manufacturing protocols contained in the Quality Agreement and such other terms and conditions as the Parties may agree. The Commercial Supply and License Agreement shall also include the terms of the license from, and royalty payable to, BioMarin related to Epro’s use of the Project Intellectual Property Rights in Epro’s Field of Use and the terms related to other commercial applications for the Product or the Project Intellectual Property Rights, all as set forth in the Term Sheet.

 

5.4 To facilitate this process, the Parties will use their best efforts to negotiate and execute a Commercial Supply and License Agreement within ninety (90) days after the date of this Agreement. If the Parties are unable to finalize the Commercial Supply and License Agreement, senior management of each Party will discuss all open issues and, if still unable to finalize the Commercial Supply and License Agreement, will participate, in good faith, in commercial mediation to resolve any open issues. The cost of such mediation shall be split equally between the Parties.

 

SECTION 6—COSTS

 

6.1 BioMarin has previously paid [****] in connection with the execution of the Term Sheet and has paid an additional [****] one month after execution of the Term Sheet. Such amounts shall be a credit against BioMarin’s first payments due pursuant to Section 6.2(a)(i) .

 

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6.2 The Costs for the Project, including VAT if applicable, shall accrue as incurred by Epro and shall be invoiced on a monthly basis, in arrears, to BioMarin in accordance with the following:

 

(a) For Epro’s evaluation, development and optimization of new synthetic routes for Product manufacturing, as provided in Section 4 , and [****] grams of Products for each delivery (as provided in Schedule 2 ), the Parties will pay as follows:

 

(i) BioMarin will pay [****] of Costs up to total incurred Costs of [****] and Epro will pay [****] of these costs;

 

(ii) between [****] of total incurred Costs, BioMarin will pay [****] of these Costs and Epro will pay [****] of these costs; and

 

(iii) over [****].

 

(b) For bulk substance manufacturing of [****] (or as specified by BioMarin) of cGMP grade, chemically stable Product for clinical trials, BioMarin shall pay [****] and Epro shall pay [****] of the Costs related to such manufacturing, provided that [****]. For additional amounts of Product the Costs will be shared by the Parties as mentioned above [****].

 

6.3 The disposal of organic and all other waste is included in the Costs.

 

6.4 All invoices will be submitted to BioMarin with copies of invoices from Epro’s suppliers to support the charges. Appropriately documented Epro invoices shall be paid by BioMarin, in US Dollars, within thirty (30) days of their receipt to the bank account specified on Epro’s invoices. In the event that BioMarin does not pay any undisputed invoice within the period provided above, BioMarin will also pay interest on unpaid amounts at a rate of ten percent (10% ) per annum, until paid in-full.

 

6.5 Additionally, Epro shall carry out, at its expense, all drug substance (“ API ”) related testing, including but not limited to stability testing. BioMarin will bear 100% of the costs (and responsibility) related to clinical and commercial drug product formulation (e.g., tableting of Product, packaging and labeling) for any indication in the BioMarin Field of Use. In the event that BioMarin chooses an outside contractor for Product-related testing, Epro shall provide support, at BioMarin’s option, to the BioMarin chosen contractor for the development of Product related testing, such as API assay testing at BioMarin’s expense. Epro shall perform these services at rates to be negotiated by the Parties, provided that, in any event, such rates will be commercially reasonable.

 

6.6 BioMarin will bear 100% of costs relating to clinical trials of the Product in the indication of PKU and any other indication in the BioMarin Field of Use. BioMarin will have

 

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sole authority to direct the trials. BioMarin will bear 100% of costs relating to commercialization in the indication of PKU or any other indication in BioMarin’s Field of Use.

 

SECTION 7—MANAGEMENT OF THE PROJECT

 

7.1 The Parties hereby agree that the Project shall be under the day-to-day supervision of the Project Manager of each Party.

 

7.2 The Parties shall work in conjunction with the Project Manager to ensure the satisfactory performance of the Project.

 

7.3 The Project Manager shall be entitled to propose recommendations to the Parties to ensure that the Project meets its objectives.

 

7.4 The Project Manager shall be in charge of all managerial and scientific aspects of the Project and shall maintain communication with the Parties in connection therewith.

 

7.5 Epro shall permit any authorized BioMarin representatives to visit, during regular business hours, the site where the Project is being conducted to evaluate the progress thereof, unless such visit would conflict with a prearranged visit by another client. This includes permitting authorized BioMarin representatives in the plant during clinical manufacturing runs. Said visit shall be made subject to five (5) days advanced notice of the requirement of such visit, such notice to be given to Epro by BioMarin.

 

7.6 The Parties may use electronic mail to communicate during the performance of the Project. The Parties shall use all reasonable measures to ensure the confidentiality of information so communicated. Documents will be transmitted as secured PDF documents with controls and digital signatures as determined by the BioMarin Information Technology department. Electronic control measures will be controlled, developed and paid for by BioMarin. Epro will work with BioMarin to develop and implement electronic communication security.

 

SECTION 8—AUDITS AND CUSTOMER REGULATORY APPROVALS

 

8.1 Epro grants BioMarin the right to audit or to appoint third parties to audit, at any reasonable time, the facilities employed and the documentation utilized by Epro for performing the Project, usually once per year. BioMarin will notify Epro at least ten (10) calendar days in

 

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advance of such an audit by BioMarin or by a third party. Both Parties will bear their own costs associated with such audits.

 

8.2 Epro permits inspections of Epro’s facilities by governmental authorities of all jurisdictions (such as the United States Food and Drug Administration and equivalent European regulatory authorities) for any import or export license, registration or pending registration for manufacturing of Product during the term of this Agreement.

 

8.3 For up to ten (10) years after the last registration or commercial sale approval requested by BioMarin for Product has been granted by governmental authorities, Epro shall store all Documents, or a copy thereof if the Documents have been provided to BioMarin, under conditions similar to the conditions under which Epro stores its own important information. BioMarin shall inform Epro of the date of the last granted Product registration or commercial sale approval. At BioMarin’s written request, Epro will deliver the Documents immediately, or the copy thereof, to an address indicated by BioMarin or destroy the Documents or the copy thereof.

 

SECTION 9—SUBCONTRACTING

 

Epro shall not be entitled to subcontract any portion of its obligations hereunder to any third party unless BioMarin has provided prior written approval for Epro to utilize the subcontracted party for the specific activities undertaken, which approval may only be withheld with reasonable grounds in writing. BioMarin has therefore the right to review any contract between Epro and any subcontractor. Epro will be responsible for all activities of any subcontractor, as if Epro had performed such activities. As a condition to any subcontracting, such subcontractor must agree to grant BioMarin the inspection, audit, documentation, intellectual property and other rights related to the services to be provided by the subcontractors as if Epro had provided the services directly. Signing of this Agreement by BioMarin will serve as retroactive, prior written approval for Epro to utilize Solvias and Prof. W. Pfleiderer as a subcontracted party .

 

SECTION 10—PROJECT INTELLECTUAL PROPERTY RIGHTS

 

10.1 BioMarin declares that it has the full right and title to make available the BioMarin Technology to Epro. Epro may use the BioMarin Technology solely to perform the Project. Epro declares that it has the full right and title to make available the Epro Technology to BioMarin. BioMarin may use the Epro Technology solely as provided in this Agreement.

 

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10.2 All BioMarin Proprietary Information shall remain the sole and exclusive property of BioMarin. BioMarin will grant Epro a nonexclusive, royalty-free, worldwide license for use of BioMarin derived preclinical and clinical data evaluating API to Epro for regulatory filings in Epro’s Field of Use. All Epro Proprietary Information shall remain the sole and exclusive property of Epro, which explicitly shall include the already existing know-how as well as the know-how developed during this Agreement for the stabilization of the Product.

 

10.3 Both Parties shall own in equal shares all Project Intellectual Property Rights. Epro and BioMarin shall be listed as co-owners on intellectual property filings related to the Project Intellectual Property Rights. Each Party shall promptly disclose to the other Party the development or discovery of any Project Intellectual Property Rights considered to be patentable or the subject of any form of registration to the other Party. All references to a patent (or patentable) in this Article 10 shall include any similar registration or filing in any country intended to protect the Parties’ interest in Project Intellectual Property Rights.

 

10.4 For a fast first filing e.g. a provisional or a priority patent application related to Project Intellectual Property Rights, Epro shall, as soon as possible, execute all instruments and do all things reasonably necessary to file patents or to seek similar protection for the Project Intellectual Property Rights jointly in the name of Epro and BioMarin. Both Parties will bear, in equal shares, all costs and responsibility for all aspects of patent filings, patent prosecution and patent defense related to the Intellectual Property Rights, including all costs and strategy decisions.

 

10.5 Each Party shall promptly inform in writing the other Party which of its employee(s) is or are involved in the development of any particular Project Intellectual Property Right. Depending on each individual’s involvement in invention development, such employees will be listed as inventors on patent filings related to the Project Intellectual Property Rights.

 

After the first patent filing according to Section 10.4, the Parties will hereinafter agree on an appropriate course of action for filing applications for Project Intellectual Property Rights, including which Party is to be responsible for the preparation, filing and prosecution of such applications and in which countries of the world to file such applications, subject to the minimum requirements below. The filing of such applications, and the maintenance of any resulting patents, on Project Intellectual Property Rights shall be subject to mutual agreement between the Parties. All costs related to patent applications, prosecution and maintenance for Project Intellectual Property Rights shall be shared equally between the Parties, unless otherwise agreed by the Parties.

 

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The other Party shall, at its own cost furnish the filing Party with all documents, or other assistance, that may be necessary for the filing and prosecution of each such application. The filing Party shall keep the other Party fully informed and provide an opportunity to advise and comment in the preparation, prosecution and maintenance of the Project Intellectual Property Rights according to the provisions of this Section 10.5. Unless otherwise agreed by both Parties in writing, the minimum required activities for patent filing and prosecution include :

 

(a) maintain system for submission, review and record-keeping of invention disclosures;

 

(b) assess patentability and freedom to operate of proposed inventions;

 

(c) file provisional or non-provisional applications on patentable subject matter;

 

(d) within one year of filing a provisional application, make a decision whether to convert to nonprovisional or file nonprovisional claiming priority to provisional application;

 

(e) file continuations, continuations-in-part, and divisionals as necessary such as including but not limited to maintain pendency, to add new subject matter such as data, and to prosecute different sets of inventions in response to an objection based on Unity or to a restriction requirement;

 

(f) file PCT applications within a year of filing the provisional or nonprovisional applications;

 

(g) enter National Phase in a minimum of the following countries including Canada, Australia, Japan, Europe, and United States to obtain foreign patent coverage;

 

(h) respond to all actions, administrative and substantive, issued by the USPTO and foreign equivalents in a timely manner before the drop deadlines to avoid abandonment;

 

(i) maintain annuities for all issued US patents and pending or granted foreign patents; and

 

(j) maintain updated patent docketing system and patent files.

 

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10.6 In the event that one of the Parties (the “First Party ”) desires to file an application for Project Intellectual Property Rights in one or more countries wherein the other Party does not want to file, the First Party shall be entitled to file or have filed in its own name applications for such Project Intellectual Property Rights in such country(s) and shall be the sole owner of the resultant Intellectual Property Rights in such country(s) and, for purposes of such country(s) only, such Intellectual Property Rights shall no longer be considered Project Intellectual Property Rights. All additional costs related or pursuant to such filing, including prosecution costs, maintenance costs of the application for and Intellectual Property Rights granted thereon shall be paid by the First Party. In such countries, the other Party shall keep its right to use such Project Intellectual Property Right for internal purposes only and without a right to grant sublicenses. Relinquishing rights to any particular Project Intellectual Property Rights in one or more countries shall not affect such Party’s rights with respect to any other country or any other Intellectual Property Rights. In case the First Party would like to abandon such Intellectual Property Rights in a specific country it shall offer the other Party such Project Intellectual Property Rights and the other Party may accept such offer within four (4) weeks after receipt of such offer.

 

10.7 In the event that one Party wants to stop the payment of its share of the maintenance fees or other costs in any country related to any particular patent filing for any Project Intellectual Property Right, the other Party may assume responsibility for all such costs. The Party discontinuing to pay its proportionate share for one or more countries shall forthwith relinquish to the other Party, which continues such payments, its title to and interest in such jointly owned Project Intellectual Property Rights for the countries concerned and, for purposes of such country(s) only, such Intellectual Property Rights shall no longer be considered Project Intellectual Property Rights. The relinquishing Party shall no longer have the right to use such Intellectual Property Rights, but the rights of third parties under already existing licenses and agreements shall not be prejudiced. Relinquishing rights to any particular Project Intellectual Property Rights in one or more countries shall not affect such Party’s rights with respect to any other country or any other Intellectual Property Rights.

 

10.8 Notwithstanding Sections 10.6 or 10.7, in the event that a Party relinquishes its rights to any Project Intellectual Property on one or more countries pursuant to Section 10.6 or 10.7, at any time thereafter, the other Party will assign a one half interest in such Intellectual Property Rights for such country(s) to the relinquishing Party upon the payment by the relinquishing party of [****] had it elected to pay its portion of the patent filing, prosecution and maintenance costs. After such payment, such Intellectual Property Rights shall again be considered Project Intellectual Property Rights, subject to the terms of this Agreement.

 

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10.9 Except as otherwise expressly provided herein, each Party shall have an equal, undivided interest in and to Project Intellectual Property Rights. Subject to the limitations, including the payment of royalties, as contained in this Agreement, each Party shall have the right to use the Project Intellectual Property Rights, as it deems appropriate in its Field of Use. A license to third parties to such Project Intellectual Property Rights outside the Field of Use of each of the Parties shall, however, be granted by one Party only after receipt of the other Party’s written consent which may be withheld for any reason whatsoever.

 

10.10 If one of the Parties becomes aware of (i) any product or activity of any kind that involves or may involve an infringement or violation of Project Intellectual Property Rights, or (ii) any third-party action, claim or dispute (including, but not limited to, actions for declaratory judgment alleging the invalidity or non-infringement) based upon or arising out of Project Intellectual Property Rights, then such Party shall promptly notify the other in writing of any such infringement, violation, action, claim or dispute.

 

Both Parties will then have the right commonly:

 

(a) to determine the appropriate course of action to enforce, or otherwise abate the infringement of, or defend third-party actions regarding, such Project Intellectual Property Rights;

 

(b) to take, or refrain from taking, appropriate action to enforce, or defend third-party actions regarding such Project Intellectual Property Rights;

 

(c) to control any litigation or other enforcement action regarding such Project Intellectual Property Rights; and

 

(d) to enter into, or permit, the settlement of any such litigation or other enforcement action regarding such Project Intellectual Property Rights.

 

10.11 Notwithstanding anything contained in the preceding sentence, neither Party will settle any suit or action or otherwise consent to an adverse judgment in such suit or action without the other Party’s prior written consent, which consent shall not be unreasonably withheld. Each Party shall keep the other informed on a regular basis on its taking or refraining from taking, and the development of, any of the foregoing actions, and shall consider, in good faith, the interests of the other under this Agreement when taking any of the foregoing actions. Each Party shall, at its own cost, fully cooperate with the other in the planning and execution of any suit or other action to enforce, or defend third-party actions.

 

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All monies recovered upon the final judgment or settlement of any suit or other action under this Section shall be allocated first to reimbursement of fees and expenses of each Party reasonably incurred in such action and then (a) to the extent that the infringement relates to BioMarin’s Field of Use, such remaining amounts shall be considered sales revenue of BioMarin attributable to the Product; (b) to the extent that the infringement relates to Epro’s Field of Use, such remaining amounts shall be considered sales revenue of Epro attributable to the Product; (c) to the extent that it does not relate to either the BioMarin or Epro Field of Use, such remaining amounts will be equally shared and (d) to the extent that the infringement relates to more than one of the categories described in (a)-(c), such amounts shall be equitably allocated to such categories, based on the nature of the infringement.

 

10.12 If a Party does not within ninety (90) days, or any shorter delay imposed by any applicable law or regulation or court or authority having jurisdiction, after receiving notice of any infringement or violation of Project Intellectual Property Rights, or of any third-party action, claim or dispute based upon or arising out of Project Intellectual Property Rights, want to commence or take an action to enforce, or otherwise abate such infringement, or defend against such third-party action, then the other Party shall have right at its sole expense, but not the obligation to initiate adequate steps as mentioned above and shall be solely responsible for all expenses associated therewith.

 

10.13 Consistent with its commercialization role, BioMarin shall be responsible for and will decide, in its sole discretion, about all aspects of the filing, prosecution, defense and maintenance of trademarks relate