DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT

“Affiliate” means, with respect to any Person, any other Person directly or indirectly controlling, controlled by, or under common control with, such other Person. For purposes hereof, the term “controlling” (including the terms “controlled by” and “under common control with”), as used with respect to any Person, will mean the direct or indirect ability or power to direct or cause the direction of management policies of such Person or otherwise direct the affairs of such Person, whether through ownership of at least fifty percent (50%) of the voting securities of such Person, by contract or otherwise. In addition and not in limitation of the foregoing, the following entities shall be deemed Affiliates of RELIANT: (i) PharmBay Investors, LLC; (ii) Bay City Capital Fund II, L.P.; and (iii) any of the lineal descendants of Nicholas J. Pritzker, deceased, trusts

primarily for the benefit of such lineal descendants, entities controlled by such lineal descendants and/or trust for their benefit.

“Confidential Information” means, with respect to any Person (including, without limitation, the parties hereto), all proprietary or confidential information of such Person (including such Person’s Affiliates and subsidiaries), including, without limitation, any non-public Intellectual Property, Know-How, financial information, procurement requirements, purchasing, manufacturing, customer or supplier information, business forecasts and plans, financing information, detailing, sales and merchandising, and marketing plans and information, pricing,

and accounting policies and procedures of or related to such Person; provided, however, that Confidential Information shall not include and information that (a) was or becomes generally available to the public other than as a result of an unauthorized disclosure by a party hereto or any of such party’s subsidiaries, Affiliates, employees, agents or representatives; (b) was or becomes available to a party hereto on a non-confidential basis from a source other than (in the case of future information) any other party hereto (or any of such party’s subsidiaries, Affiliates, employees, agents or representatives), provided that such source was not known be bound by any agreement to keep such information confidential or otherwise prohibited from transmitting the information by a contractual, legal or fiduciary obligation; or (c) is independently developed by any party hereto without the use of or reference to the Confidential Information of the other party hereto or any of such other party’s subsidiaries or Affiliates.

“IND” shall mean an Investigational New Drug Application under the Act (together with all subsequent submissions, supplements and amendments thereto,

and any materials, documents or information referred to or relied upon thereby) seeking authorization to commence clinical trials of the Product in humans, and similar applications or filings in the other countries within the Territory.

“Know-How” means any and all proprietary methods, devices, technology, trade secrets, inventions, compositions, designs, formulae, know-how, show-how, technical and training manuals and documentation and other information, including, without limitation, processes and analytical methodologies used in

development, testing, analysis and manufacture, and medical, clinical and toxicological testing as well as other scientific data of ETHYPHARM, which is related to or used in connection with the Product or any ingredient thereof, and/or the formulation, development, registration, manufacture, packaging, labeling, import, export, receipt, shipment, storage, use, pricing or sale thereof, whether now known or hereafter developed.

“Net Sales” means the aggregate amounts invoiced by RELIANT for sales of the Product produced using ETHYPHARM Intellectual Property to independent and

unrelated third-parties in the Territory, less any and all (a) trade, quantity and cash discounts; (b) commissions, discounts, refunds, rebates, chargebacks, retroactive price adjustments and any other allowances which effectively reduce the net selling price; (c) returns, bad debts and uncollectible accounts; (d) Taxes collected, charged or otherwise required to be paid by RELIANT in respect thereof; and (e) insurance, freight, warehousing and other transportation and storage costs related to shipment of the Product.

“Product” means a product composed of or containing micronized fenofibrate, in any dosage form, including encapsulated or bulk beads, granules or similar

presentations, including, without limitation, the fenofibrate product developed by ETHYPHARM for RELIANT pursuant to this Agreement and the Product Development Program.

“Tax(es)” means, with respect to any Person, all federal, state, local, county, foreign and other taxes, assessments or other government charges, including, without limitation, income, estimated income, gross receipts, profits, business, license, occupation, franchise, capital stock, real or personal property, sales use, transfer, value added, employment or unemployment, social security, disability,

alternative or add-on minimum, customs, duty, excise, stamp, environmental or withholding taxes, including interest, penalties and additions in connection therewith for which such Person may be liable (including any such tax related to any other Person for which such Person is liable, by contract, as transferee or successor, by law, treaty or otherwise).

Product Development Program; Dosages. During the Term of this Agreement, ETHYPHARM and RELIANT shall develop the Product consistent with the terms of this Agreement in accordance with product development program set forth on Exhibit B attached hereto (the “Product Development Program”), which Exhibit B specifies the proposed development timetable and each party’s respective responsibilities related to the development of the Product for sale in the Territory, including, without limitation, the preparation and filing of an NDA and the conduct of clinical trials related to the Product. As part of the Product Development Program, RELIANT shall establish a highest dosage (currently anticipated to be between 120mg and 200mg of API per capsule), however, RELIANT, at its option, may develop in collaboration with ETHYPHARM and conduct clinical trials in respect of other formulations and/or dosage forms of the Product. ETHYPHARM shall develop the formulations and dosage forms of the Product and manufacture the Product in

such formulations and dosage forms as shall be requested by RELIANT or otherwise required to comply with the Act and any applicable NDA and in compliance with the Product Development Program.

revoked, cancelled, withdrawn or otherwise impaired as a result of any act or omission by or behalf of ETHYPHARM of the types described in Section 4.4.

Regulatory Applications and Related Filings. Provided that ETHYPHARM satisfies its obligations under Section 2.5 and the Product Development Program in a timely manner, RELIANT shall exercise its commercially reasonable efforts to prepare, file and prosecute all necessary applications, submissions and regulatory filings (together with all documentation, correspondence and other supporting materials related thereto, collectively, the “Regulatory Applications”) to obtain any Applicable Permits required to market the Product in the United States promptly following completion of the Product Development Program and in any event within a maximum period of six (6) months from completion of the Product Development Program. Upon the completion of those portions of the Product Development Program applicable to Canada and Mexico, RELIANT shall use its commercially reasonable efforts to file Regulatory Applications in those countries and in any event within a maximum period of six (6) months from completion of those portions of the Product Development Program applicable to these countries of the Territory. All Regulatory Applications shall be filed and submitted in RELIANT’s name and shall be owned exclusively by RELIANT, and all Applicable Permits issued pursuant thereto shall be in the name of and owned exclusively by RELIANT. RELIANT shall be responsible for obtaining any and all necessary regulatory approvals from any Governmental Authority under any Applicable Law or Applicable Permit as a result of any changes to the Specifications requested by RELIANT and for reporting any such modifications to the Specifications to the

applicable Governmental Authority as appropriate. In the event that the submission of the Regulatory Applications does not take place within the time periods specified in this Section 2.4 as a result of RELIANT’s breach of this Agreement or other refusal to submit such Regulatory Applications, then ETHYPHARM, as its sole remedy hereunder, may, upon at least sixty (60) days prior written notice to RELIANT, convert the exclusive license granted to RELIANT pursuant to Section 3.1 to a non-exclusive license solely in that country of the Territory where RELIANT failed to submit such Regulatory Application; provided, however, that RELIANT shall have the option, but not the obligation, for a period not to exceed eighteen (18) months to make an additional payment of $3,000 per day with respect to the United States ($300 per day with respect to each of Canada and Mexico), payable monthly in arrears, in which case ETHYPHARM shall not have the right to convert the License to a non-exclusive license in said country (it being agreed that such payments shall be made until such time as the Regulatory Application is submitted for the country in question).

ETHYPHARM’s Development Responsibilities. Notwithstanding RELIANT’s obligations under Section 2.4 to the contrary, ETHYPHARM shall prepare and deliver, and shall cause each applicable supplier or other third party (other than RELIANT) involved with the manufacture and packaging of the Product to prepare and deliver, to RELIANT and, as applicable, file or cause to be filed with the appropriate Governmental Authority: (a) the DMF, which shall be filed with FDA for the manufacture of the Product; and (b) the CMC section of the IND and the NDA, all of which shall be in accurate and complete, and in form and substance reasonably satisfactory to RELIANT and suitable for inclusion in the applicable filing. ETHYPHARM shall, at its own cost, cooperate with and assist RELIANT in the preparation, filing and prosecution of the Regulatory Applications, and shall prepare and deliver such other documents, and take such other actions, as may be necessary or appropriate to apply for, prosecute or obtain any Applicable Permits. All materials to be prepared by or on behalf of ETHYPHARM hereunder shall be prepared and delivered and, as applicable, filed, in timely manner in accordance with timetable established by the parties

hereunder. ETHYPHARM shall provide RELIANT with sufficient opportunity to review and comment upon all Regulatory Applications or portions thereof prepared by or on behalf of ETHYPHARM prior to their submission to any Governmental Authority. In the event that RELIANT requests any modifications to the Regulatory Applications or portions thereof required to be prepared by ETHYPHARM hereunder, the parties shall discuss such modifications in good faith; provided, however, that the party in whose name the Regulatory Application is being made shall retain the ultimate right to determine the contents thereof. In connection with this Agreement, ETHYPHARM shall also provide RELIANT with full access to all of its information and records, including, without limitation, its Intellectual Property and Confidential Information, related to the Product and its formulation, manufacture and packaging (including, without limitation, formulation, development, pharmacology and clinical data regarding the Product, any ingredient thereof (including fenofibrate)) in order that RELIANT may obtain and maintain the Applicable Permits contemplated by this Agreement and comply with Applicable Law.

Grant of License; License Exclusion. Subject to the terms set forth herein and in consideration for the payments set forth in Sections 4, 8 and 9 hereof,

ETHYPHARM hereby grants to RELIANT the exclusive (even as to ETHYPHARM) royalty-bearing license to all of ETHYPHARM’s Intellectual Property related to the Product to make or have made (except to make or have made the Product in Bulk Product Form), develop, import, export, within the Territory, use, distribute, promote, market, sell and otherwise fully exploit the Product, in whatever formulation or dosage form, within the Territory (the “License”); provided, however, that the License shall not prevent ETHYPHARM from developing, manufacturing, licensing, promoting and marketing other products containing fenofibrate as the main active pharmaceutical ingredient in the form of microgranules, directly or through third parties, provided that fenofibrate is combined with another active pharmaceutical ingredient which does not belong to the statin family and for which there is no valid patent in the Territory (a “License Exclusion Transaction”).

RELIANT Right of First Refusal Regarding License Exclusion Transactions. In the event that ETHYPHARM desires to enter into or consummate a License Exclusion Transaction, ETHYPHARM agrees that it shall first provide RELIANT with at least sixty (60) days prior written notice of such proposed Licensed Exclusion Transaction specifying the terms and conditions of the proposed product, product specifications, manufacturing specifications, product development program, license and royalty arrangement and marketing strategy related thereto (each, a “LET Notice”). Following delivery of any LET Notice, ETHYPHARM shall provide RELIANT with such information as RELIANT may reasonably request in order to allow RELIANT to evaluate the proposed License Exclusion Transaction described therein. Within sixty (60) days following its receipt of the LET Notice, RELIANT shall have the right, but not the obligation, upon delivery of written notice to ETHYPHARM to agree to enter into the transaction described by the LET Notice upon the terms and conditions stated therein. In the event that RELIANT notifies ETHYPHARM in writing that it does not wish to exercise its rights under this Section 3.2 or fails to respond to such LET Notice within such sixty (60) day period,

ETHYPHARM shall be free to enter into the License Exclusion Transaction described therein with a third party; provided, however, that ETHYPHARM may not offer to such third party any terms or conditions more favorable to such third party than those described in the LET Notice without first re-offering such opportunity to RELIANT pursuant to this Section 3.2; provided, further, that in the event ETHYPHARM shall not have entered into a binding agreement with such third party within one hundred eighty (180) days following the date of the LET Notice, ETHYPHARM shall not enter into or consummate such License Exclusion Transaction without re-offering such opportunity to RELIANT pursuant to this Section 3.2.

Launch Date Anniversary

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Capsules to Be Sold

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Launch Date Anniversary

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Competing Dosage Form within the Territory, without the prior written consent of ETHYPHARM; provided, however, that the foregoing restriction shall not prevent RELIANT from developing, having developed, promoting, distributing or marketing any Competing Dosage Form within the Territory provided that RELIANT pays ETHYPHARM royalties in respect of such Competing Dosage Form in accordance with Section 9 of this Agreement; provided, further, that should RELIANT decide to develop or have developed any Competing Dosage Form within the Territory, RELIANT shall send ETHYPHARM a written notification of such decision in order to enable ETHYPHARM to propose within a maximum period of sixty (60) days from receipt of the written notification a similar or comparable product to the Competing Dosage Form; provided, further, RELIANT agrees to give ETHYPHARM at least ten (10) days prior written notice of RELIANT’s decision to promote, distribute or market any existing any Competing Dosage Form within the Territory. For the avoidance of doubt, the parties agree and acknowledge that the restrictions in this Section 3.5 shall not apply to any Combination Product.

ETHYPHARM Failure to Abide by Product Development Program. In the event that ETHYPHARM either (a) fails to prepare, deliver and, as applicable, file with the appropriate Governmental Authorities any of the materials required to be so prepared, delivered and/or filed by or on behalf of ETHYPHARM pursuant to the Product Development Program or any provision hereof, including, without limitation, Section 2.5 hereof, by the applicable deadline, or (b) fails to deliver to RELIANT any Product required to conduct any clinical trials, file any Regulatory Applications or that is otherwise required to be delivered by ETHYPHARM under this Agreement or the Product Development Program by the applicable deadline, then the amount of the payments due to ETHYPHARM pursuant to Sections 4.1 and 4.2 hereof shall be reduced by the amount of US$3,000 for each day or portion thereof after such deadline with respect to which ETHYPHARM failed to make such delivery or file such materials. The parties agree that this provision is in addition to any other rights or remedies either of the parties may have under this Agreement. Notwithstanding the foregoing, the parties agree (a) to meet and discuss in good faith any revised deadlines under the Product Development Program, and (b) to provide each other with notice of, and a reasonable

opportunity to resolve or mitigate, any problem or other issue that arises with respect to the Product Development Program and/or the NDA.

Clinical Formulations and Placebos. ETHYPHARM shall manufacture, deliver and sell to RELIANT such quantities of validated clinical formulations of the Product, in such formulations and dosage forms as requested by RELIANT, together with matching quantities of placebos, to enable RELIANT to conduct all clinical trials to be conducted pursuant to the Product Development Program established hereunder. All Product, regardless of formulation or dosage form, and placebos for use by RELIANT in clinical trials shall be: (a) sold to RELIANT at ETHYPHARM’s actual cost as determined in accordance with Exhibit D attached

hereto; and (b) delivered by ETHYPHARM within thirty (30) days of ETHYPHARM’s receipt of RELIANT’s order therefor.

commercially reasonable efforts to commence commercial sales of the Product within the six (6) month period specified herein; provided, however, that RELIANT shall have the option, but not the obligation, for a period not to exceed eighteen (18) months to make an additional payment of $3000 per day with respect to the United States ($300 per day with respect to each of Canada and Mexico), payable monthly in arrears, in which case ETHYPHARM shall not have the right to convert the License to a non-exclusive license in said country (it being agreed that such payments shall be made until such time as commercial sales of the Product commence in the country in question).

hereunder, in accordance with the Specifications and the terms and conditions of this Agreement.

Patents. Each party shall be responsible, at its own expense, for filing and prosecuting such patent applications, as it deems appropriate, and for paying maintenance fees on any patents issuing therefrom, for the term of this Agreement, with respect to inventions owned by it that relate to or are used in connection with the manufacture, packaging, sale or use of the Product and which are necessary for, used in connection with or otherwise related to the performance of this Agreement by either party hereto. Notwithstanding anything herein to the contrary, ETHYPHARM, at its sole cost and expense, shall continue to prosecute and maintain each of the Patents and shall keep RELIANT advised of all actions relative to the same. If ETHYPHARM fails to carry out the obligations set forth in this Section 6.2 with respect to the Patents, RELIANT may carry out such obligations on ETHYPHARM’s behalf at ETHYPHARM’s cost and may set off such cost against any amounts due to ETHYPHARM hereunder thereafter. Each party shall promptly render all necessary assistance reasonably requested by the

other party in applying for and prosecuting patent applications based on Intellectual Property owned by such other party under this Agreement. Except as otherwise provided herein, patents covering joint inventions, if any, shall be owned by the parties jointly, and the parties shall share equally in the expenses of filing for and maintaining such patents and any royalties attributable thereto. ETHYPHARM’s obligations in respect of patents pursuant to this Section 6.2 shall apply only to those patents used in the manufacture of the Product or otherwise related to the Product or necessary for the full and timely performance of ETHYPHARM’s obligations under this Agreement.

ETHYPHARM Indemnified Claims. In the event that any third party brings or threatens to bring a claim against either party hereto and/or any of its Affiliates that alleges or demonstrates infringement of such third party’s Intellectual

Property rights arising out of, resulting from or otherwise related to (i) the Product, including the formulation, the manufacture of the Product or the micronization of the API and the non-active ingredients contained therein, or (ii) any ETHYPHARM Intellectual Property used by RELIANT, its Affiliates, sublicensees or agents as contemplated by this Agreement (such claims, together, “ETHYPHARM Indemnified Claims”), ETHYPHARM shall defend such action at its own cost and expense, and shall, at its own cost and expense, indemnify and hold harmless RELIANT and RELIANT’s Affiliates, officers, managers, employees, trustees, representatives, consultants, sublicensees and agents (the “RELIANT Infringement Indemnitees”) as set forth in Section 6.7 below. With respect to the manufacture (but not the micronization) of the API, in the event that (a) any third party brings or threatens to bring a claim against either party hereto and/or any of its Affiliates that alleges or demonstrates infringement of such third party’s Intellectual Property rights arising out of, resulting from or otherwise related to the manufacture of the API, and (b) ETHYPHARM’s supplier of the API fails to defend, indemnify and hold harmless ETHYPHARM from such claim, both parties shall cooperate in the defense of such action and equally bear the cost and expenses thereof (it being agreed, in any event, that any indemnification or other rights or amounts received by ETHYPHARM from such supplier in respect of or as result of such claim shall be applied to the defense of such claim hereunder).

RELIANT Indemnified Claims. In the event that any third party brings or threatens to bring a claim against either party hereto and/or any of its Affiliates

that alleges or demonstrates infringement of such third party’s Intellectual Property rights arising out of, resulting from or otherwise related to any RELIANT Intellectual Property used by RELIANT, its Affiliates, sublicensees or agents as contemplated by this Agreement (such claims, together, “RELIANT Indemnified Claims”), RELIANT shall defend such action at its own cost and expense, and shall, at its own cost and expense, indemnify and hold harmless ETHYPHARM, its Affiliates, officers, managers, employees, representatives, consultants and agents (the “ETHYPHARM Infringement Indemnitees”) as set forth in Section 6.8 below.

Third Party Infringement. In the event either party believes that a third party is infringing or otherwise violating any party’s Intellectual Property rights with respect to or related to the Product in the Territory (a “Third Party Infringement”), ETHYPHARM and RELIANT shall consult with each other and their respective counsel in order to develop a strategy for addressing the Third Party Infringement. In the event the parties agree to take legal action to stop the Third Party Infringement, they shall agree upon legal counsel to prosecute such action. Unless the parties agree upon a different formula for sharing the expenses (including attorney and expert fees) of such action and for sharing any award or settlement, the owner of such Intellectual Property shall bear the costs of such

action and shall be entitled to any award or settlement in respect thereof. In the event that one of the parties does not desire or is otherwise unwilling to participate in the action (the “Nonparticipating Party”), the other shall be free to bring the action in its own name, at its own expense and retain any award or settlement in its entirety; provided, however, that if such third party infringement adversely affects either party’s rights or obligations hereunder, then the costs of such action shall be borne by the owner of such Intellectual Property, regardless of which party brings or prosecutes such action. If necessary, the Nonparticipating Party shall join as a party to the suit but shall be under no obligation to participate except to the extent that such participation is required as the result of being a named party to the suit. The Nonparticipating Party shall offer reasonable assistance in connection therewith at no charge to the other party except for reimbursement of reasonable out-of-pocket expenses including reasonable attorney’s fees. If either party desires to retain counsel independently, the party may do so, but it shall not relieve the party of its obligations under this Section 6.9.

Termination Resulting From Infringement. In the event that Intellectual Property belonging to any party and necessary for, used in connection with or otherwise related to the performance of this Agreement by any party hereto is determined to violate or infringe upon any Intellectual Property rights of any third party, and the owner of said Intellectual Property is unable to obtain for itself and the benefit of the other party and its sublicensees, if any, at no additional cost to said other party and/or any of its sublicensees, a license to use the Intellectual Property upon

which the claims for infringement or violation is based, then said other party shall have the right to terminate this Agreement in addition to any other rights or remedies it may have hereunder or at law or in equity.

Applicable Laws and Applicable Permits; (b) be consistent with the DMF and CMC, and produced in a facility and in a manner compliant with cGMP and all other Applicable Laws; (c) not be adulterated or misbranded within the meaning of the Act; (d) be manufactured under cGMP conditions at ETHYPHARM’s facility in Chateauneuf-en-Thymerais, France, or, upon at least thirty (30) days prior written notice to RELIANT, at the Additional Manufacturing Facility, which facility shall at all times during such manufacture be an FDA-approved manufacturing facility and shall manufacture, package, label, store and handle the Product in accordance with all Applicable Laws and Applicable Permits; and (e) be in such formulation and dosage form (e.g., Bulk Product Form or Finished Dosage Form) as requested by RELIANT. All shipments of the Product to be delivered to RELIANT under this Agreement, regardless of the formulation or dosage form thereof, shall be sampled and analyzed by or on behalf of ETHYPHARM to confirm that it meets the Specifications. ETHYPHARM shall deliver or cause to be delivered to RELIANT with each shipment of the Product a certificate of analysis stating that the Product in the formulations and dosage forms provided meets the applicable Specifications. ETHYPHARM agrees that neither it nor any third party manufacturer of the Product shall make any changes in the formulation, manufacture, production, packaging, storage and/or shipment of the Product without the specific written prior approval of RELIANT unless expressly required by Applicable Law (including, without limitation, cGMP or the Act), in which case ETHYPHARM shall notify RELIANT in writing immediately of such change and the reason therefor. The responsibility for the final release of

the Product delivered by ETHYPHARM to RELIANT for sale or distribution in the Territory shall remain with RELIANT.

Purchase and Sale; Acceptance. Subject to the terms hereof, during the Term of this Agreement, ETHYPHARM shall sell and deliver to RELIANT, and RELIANT shall purchase and accept, the Product pursuant to orders submitted by

RELIANT to ETHYPHARM in accordance with provisions hereof. All deliveries of Product shall be deemed accepted by RELIANT unless RELIANT shall deliver an Exception Notice to ETHYPHARM in accordance with Section 7.6 hereof.

Shipment Costs; Title and Risk of Loss. All Product to be delivered to RELIANT under this Agreement shall be shipped by ETHYPHARM to RELIANT fully insured against risk of loss, theft, seizure and destruction at ETHYPHARM’s cost. Title and risk of loss with respect to the all shipments of Product shall pass from

ETHYPHARM to RELIANT upon acceptance by RELIANT at RELIANT’s dock (currently located in Somerset, New Jersey, USA). In the event of delivery at another location(s) within the Territory as may be specified by RELIANT or RELIANT’s sublicensee(s), the delivery prices agreed upon between the parties shall be reconsidered in order to take into account the possible increase due to such new location or insurance and transportation costs.

Notice of Third Party Audit. ETHYPHARM shall give RELIANT telephonic notice (with written confirmation) of any pending or threatened audit related to the Product (including, without limitation, the manufacture, production, sale, distribution, import/export or testing of the Product, in whatever form) by any Governmental Authority or other authorized Person, regardless of whether such audit is of ETHYPHARM or any Person (other than RELIANT) with which ETHYPHARM has an agreement related to the Product or any ingredient thereof or process used in connection with the manufacture thereof, including, without limitation, any suppliers of raw materials used in the manufacture of the Product or any third party engaged by ETHYPHARM to manufacture the Product, in each case which audit affects or could reasonably be expected to affect the performance of ETHYPHARM’s obligations under this Agreement or otherwise affect RELIANT’s sale or distribution of the Product (each, an “Audit”); provided, however, that ETHYPHARM shall not be required to give such notice to RELIANT of an Audit by any Person that is conducted in the ordinary course pursuant to an agreement between ETHYPHARM and such Person and not in response to any suspected violation or non-compliance. ETHYPHARM shall provide any notice to RELIANT required under this Section 7.7 as soon as practicable, but in any event within five (5) Business Days, following the date ETHYPHARM first becomes aware of such Audit, and shall provide RELIANT with any documentation or other information provided or available to it relating to any such Audit, and shall provide RELIANT reasonable opportunity to review and comment, prior to submission, any response to such Audit. ETHYPHARM

shall keep RELIANT fully apprised of the progress and results of any Audit and shall immediately provide RELIANT with the results of such Audit following its conclusion.

Recall or Withdrawal. ETHYPHARM and RELIANT will each maintain or cause to be maintained such traceability records as are necessary to permit a recall,

withdrawal or field correction of the Product (each, a “Recall”). Each party will give telephonic notice (to be confirmed in writing) to the other within twenty-four (24) hours of the receipt of any information which indicates a Recall may be necessary. The decision to conduct and the right to control a Recall will be solely that of the then current NDA owner, after appropriate consultation with the other party. Each party will cooperate fully with the other in connection with any Recall efforts. If any Recall is due to any act or omission of ETHYPHARM, ETHYPHARM will bear the cost of the Recall and replace recalled Product with conforming Product at no additional charge hereunder and will reimburse RELIANT for all of RELIANT’s reasonable direct costs and expenses actually incurred by RELIANT in connection with the Recall including, but not limited to, direct costs of retrieving Product already delivered to customers and direct costs and expenses RELIANT is required to pay for notification, shipping and handling charges; provided, however, that for each such Recall (a) RELIANT will in good faith consult with ETHYPHARM and, to the extent commercially reasonable, implement ETHYPHARM’s recommendations on how best to conduct the Recall including, without limitation, the notification and retrieval of Product, and (b) prior to any reimbursement hereunder, RELIANT will provide ETHYPHARM with detailed supporting documentation of all costs and expenses for which reimbursement is being sought. If a Recall of Product distributed is due to any act or omission of RELIANT, RELIANT will remain responsible for the costs of such Recall and will reimburse ETHYPHARM for all of the reasonable direct costs and expenses described above actually incurred by ETHYPHARM (if any)

in connection with such Recall including, but not limited to, administration of the recall and such other reasonable direct costs as may be reasonably related to the Recall. RELIANT shall not release any Product in the Territory that has not been duly controlled by RELIANT.

RELIANT Audit Right Regarding Manufacturing Facilities. Upon prior notice to ETHYPHARM and upon a minimum of one (1) month prior notice of the anticipated audit date, ETHYPHARM will permit (and will cause any owner and operator of any Additional Manufacturing Facility to permit) RELIANT to conduct an inspection and audit, of ETHYPHARM’s or such third party’s manufacturing facilities and operations used in the manufacturing, receiving, sampling, analyzing, storing, handling, packaging and shipping of Product, including, but not limited to, the receipt, storage and issuance of raw materials, labeling and packaging components and ingredients thereof (including, without limitation, all documentation related thereto) for the purpose of quality control and to assure compliance with cGMP, Applicable Laws, Applicable Permits and the terms of this Agreement. RELIANT may not conduct an audit hereunder more frequently than once during any six (6) month period prior to the Approval Date, or more frequently than once during any twelve (12) month period following the Approval Date; provided, however, that RELIANT may conduct an additional audit(s) in the event there is a quality or compliance issue concerning the Product or its manufacture that RELIANT deems in good faith to be material hereunder. RELIANT may conduct such audit using its own personnel or a third party auditor/inspector and shall conduct such audit, or cause such audit to be

conducted, during regular business hours and in such a manner so as to minimize interference with ETHYPHARM’s or any third party’s operations. ETHYPHARM will provide, and shall cause any applicable third party to provide, RELIANT with access to relevant personnel during the audit and ETHYPHARM will provide a written response to any written audit observations provided by RELIANT within thirty (30) days of ETHYPHARM’s receipt thereof.

Right of First Offer In Connection with Divestiture. In the event RELIANT decides to divest the Product in the Territory, for whatever reason, ETHYPHARM will be granted a right of first offer to acquire all rights in relation

with the Product and the relevant Intellectual Property and Confidential Information belonging to RELIANT pursuant to terms no less favorable to ETHYPHARM than those proposed to be offered third-parties, such right to be exercised within a maximum period of sixty (60) days from date of official written notification by RELIANT to ETHYPHARM. In the event ETHYPHARM does not exercise its right, RELIANT undertakes to transfer to its assignee all rights and obligations vis-à-vis ETHYPHARM provided for in this Agreement.

Indemnification of ETHYPHARM. RELIANT shall indemnify and hold harmless ETHYPHARM and its Affiliates and their respective equityholders, managers, directors, officers, trustees, agents and employees (collectively, “ETHYPHARM Indemnified Parties”) from and against all damages, losses, expenses, claims, demands, suits, penalties, judgments or administrative and judicial orders and liabilities (including reasonable legal fees and expenses) incurred, assessed or

sustained by any ETHYPHARM Indemnified Party with respect to or involving or arising out of (i) a breach by RELIANT of any representation, warranty, duty or covenant of RELIANT hereunder, or (ii) any negligent act or omission, or willful misconduct of RELIANT or any of its Affiliates or agents.

Insurance. Each party shall, at its own cost, cause the other party and its respective agents, employees, officers, shareholders and contractors to be added as additional insureds on all policies of general commercial liability insurance and product liability insurance covering such party, which coverage shall have limits of liability which are commercially reasonable but shall not be less than US$10,000,000 per loss occurrence. Each policy shall contain an endorsement

which provides that any amendments or cancellation of any such policy shall not be effective unless the other party shall have been given thirty (30) days prior written notice of any such intended amendment or cancellations. Within five (5) days of the beginning of each policy period, each party shall deliver to the other a certificate evidencing the coverage required hereby and the amount thereof. Such coverage shall be maintained for not less than five (5) years following termination of this Agreement or if such coverage is of the “claims made” type, for ten (10) years following termination of this Agreement.

Confidentiality. Each party will hold Confidential Information of the other party and its Affiliates in complete confidence and will not, without the prior written consent of the other, use or disclose it in whole or in part to any Person other than for the purposes set forth in this Agreement for a period ending five (5) years following expiration of this Agreement. Each party will be entitled to disclose any such Confidential Information to such of its professional advisers, directors,

managers, officers and employees who are directly concerned with this Agreement and its implementation and whose knowledge of such information in the opinion of the disclosing party is necessary for these purposes. Each party will use its reasonable efforts to ensure that each individual to whom such a disclosure is made adheres to the terms of this undertaking as if he or she were a party hereto. Each party may disclose such Confidential Information to the extent such disclosure is required by law; provided, however, that the disclosing party shall (to the extent permitted) give the other party prior notice of such required disclosure and cooperate with such other party in order that such other party may seek a protective order or relief to prevent or limit the Confidential Information required to be disclosed; provided, further, that the disclosing party shall only disclose that portion of the Confidential Information that such party is advised by its legal counsel is required to be disclosed by law and shall seek assurances that such Confidential Information will be maintained in confidentiality by the receiving party.

Force Majeure. If either party is prevented from complying, either totally or in part, with any of the terms or provisions set forth herein by reason of force majeure, including, by way of example and not of limitation, fire, flood, explosion, storm, strike, lockout or other labor dispute, riot, war, rebellion, accidents, acts of God, acts of Governmental Authorities, failure of suppliers or any other similar cause, in each case to the extent beyond its reasonable control, said party will provide written notice of same to the other party. Said notice will be provided within five (5) Business Days of the occurrence of such event and will identify the requirements of this Agreement or such of its obligations as may be affected, and to the extent so affected, said obligations will be suspended during the period of such disability. If any raw materials, facility systems or capacity is used for both the manufacture and packaging of the Product in satisfaction of ETHYPHARM’s obligations hereunder and any other product or purposes, any necessary allocation will be made as between ETHYPHARM’s needs, RELIANT’s needs and the needs of any other party with whom ETHYPHARM has firm contractual obligations on a basis no less favorable than pro rata on a volume basis. The party prevented from performing hereunder will use its commercially reasonable efforts to remove such disability and will continue performance whenever such causes are removed. The party so affected will give to the other party a good faith estimate of the continuing effect of the force majeure condition and the duration of the affected party’s nonperformance. If the period of any previous actual nonperformance of ETHYPHARM because of ETHYPHARM force majeure conditions plus the anticipated future period of

ETHYPHARM nonperformance because of such conditions will exceed an aggregate of ninety (90) days within any six (6) month period, RELIANT may terminate this Agreement immediately by written notice to ETHYPHARM. If the period of any previous actual nonperformance of RELIANT because of RELIANT force majeure conditions plus the anticipated future period of RELIANT nonperformance because of such conditions will exceed an aggregate of ninety (90) days within any six (6) month period, ETHYPHARM may terminate this Agreement immediately by written notice to RELIANT. When such circumstances as those contemplated herein arise, the parties will discuss in good faith, what, if any, modification of the terms set forth herein may be required in order to arrive at an equitable solution.

CONSENT TO JURISDICTION; AGENT FOR SERVICE OF PROCESS. EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY AGREES THAT ANY SUIT, ACTION, PROCEEDING OR CLAIM AGAINST SUCH

PARTY ARISING OUT OF OR IN ANY WAY RELATING TO THIS AGREEMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED HEREBY, OR ANY JUDGMENT ENTERED BY ANY COURT IN RESPECT THEREOF, MAY BE BROUGHT OR ENFORCED IN THE STATE OR FEDERAL COURTS LOCATED IN THE COUNTY OF SOMERSET IN THE STATE OF NEW JERSEY AND THE COMPANY HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY LAW, ANY OBJECTION WHICH IT MAY NOW OR HEREAFTER HAVE TO THE VENUE OF ANY PROCEEDING BROUGHT IN THE COUNTY OF SOMERSET IN THE STATE OF NEW JERSEY AND FURTHER IRREVOCABLY WAIVES ANY CLAIMS THAT ANY SUCH PROCEEDING HAS BEEN BROUGHT IN AN INCONVENIENT FORUM. ETHYPHARM HEREBY IRREVOCABLY AND UNCONDITIONALLY APPOINTS ETHYPHARM CORP., 22 UNION AVENUE, BALA-CYNWYD, PENNSYLVANIA 19004, USA (ATTENTION: HAFID TOUAM, VICE PRESIDENT), AS AGENT FOR SERVICE OF PROCESS UNDER THIS AGREEMENT.

WAIVER OF JURY TRIAL. THE PARTIES HERETO HEREBY EXPRESSLY WAIVE ANY RIGHT TO A TRIAL BY JURY IN ANY ACTION OR PROCEEDING TO ENFORCE OR DEFEND ANY RIGHT, POWER, OR REMEDY UNDER OR IN CONNECTION WITH THIS AGREEMENT OR ANY OF THE RELATED AGREEMENTS OR UNDER OR IN CONNECTION WITH ANY AMENDMENT, INSTRUMENT, DOCUMENT, OR

AGREEMENT DELIVERED OR WHICH MAY IN THE FUTURE BE DELIVERED IN CONNECTION HEREWITH OR THEREWITH OR ARISING FROM ANY RELATIONSHIP EXISTING IN CONNECTION WITH THIS AGREEMENT OR ANY RELATED AGREEMENT, AND AGREE THAT ANY SUCH ACTION SHALL BE TRIED BEFORE A COURT AND NOT BEFORE A JURY. THE TERMS AND PROVISIONS OF THIS SECTION CONSTITUTE A MATERIAL INDUCEMENT FOR THE PARTIES ENTERING INTO THIS AGREEMENT.

Hafid Touam, Vice President

RESPONSIBLE
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EVENT

VALIDATION

DELIVERABLES

DRAFT

FINAL

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COMPLETION DATE

TOPIC

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VALIDATION

DELIVERABLES

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FINAL

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PARTY

COMPLETION DATE

TOPIC

EVENT

VALIDATION

DELIVERABLES

DRAFT

FINAL

[***]

RESPONSIBLE
PARTY

COMPLETION DATE

TOPIC

EVENT

VALIDATION

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DRAFT

FINAL

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PARTY

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Year

Month

Constant Value

Point Value

Group 6A
in FRF (1)

Global

Increase

Increase

New value

Increase

New value

1997

1998

1999

2000

2001