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Reliant Pharmaceuticals/Inc · S-1/A · On 8/5/05 · EX-10.29
Filed On 8/5/05 4:44pm ET · SEC File 333-125127 · Accession Number 1193125-5-159168
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Pre-Effective Amendment to Registration Statement (General Form) · Form S-1 Filing Table of Contents
Document/Exhibit 1: 2: 3: 4: 5: 6: S-1/A EX-2.2 EX-4.1 EX-10.11 EX-10.26 EX-10.28 Description Amendment No. 2 to Form S-1 Asset Purchase Agreement Dated as of June 24, 2005 Specimen Common Stock Certificate Amended and Restated Employment Agreement Supply Agreement, Dated as of September 23, 2003 Supply and Packaging Agreement, Dated March 19, 2004 Development, License and Supply Agreement, Dated as of May 7, 2001 Letter Agreement, Dated December 18, 2002 Amendment No. 1 to Development, License and Supply Agreement License and Supply Agreement, Dated as of August 9, 2004 Amendment No. 1 to License and Supply Agreement, Dated as of Nov. 19, 2004 Manufacturing Agreement, Dated as of December 3, 2003 Development, License and Supply Agreement, Dated as of January 27, 2000 Amendment No.1 to the Development, License and Supply Agreement Manufacturing and Packaging Agreement, Dated April 14, 2005 Manufacturing Services Agreement, Dated April 6, 2004 Amended and Restated Promotion Agreement, Dated April 5, 2005 List of Subsidiaries Consent of Ernst & Young Llp Consent of Deloitte & Touche Llp Pages HTML HTML HTML HTML HTML HTML HTML HTML HTML HTML HTML HTML HTML HTML HTML HTML HTML HTML HTML HTML Size 2,300K 274K 14K 91K 127K 141K 280K 15K 79K 371K 46K 297K 191K 35K 147K 329K 541K 9K 9K 10K

7: EX-10.29 8: EX-10.29(A) 9: EX-10.29(B) 10: EX-10.30 11: EX-10.30(B) 12: EX-10.31 13: EX-10.32 14: EX-10.32(A) 15: EX-10.33 16: EX-10.34 17: EX-10.35 18: EX-21.1 19: EX-23.2 20: EX-23.3

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EX-10.29 · Development, License and Supply Agreement, Dated as of May 7, 2001

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This is an EDGAR HTML document rendered as filed. [ Alternative Formats ]

Development, License and Supply Agreement, dated as of May 7, 2001
Exhibit 10.29 CONFIDENTIAL DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT dated as of May 7, 2001 among ETHYPHARM, S.A. 194 Bureaux de la Colline 92213 Saint Cloud France and ETHYPHARM INDUSTRIES, S.A. 194 Bureaux de la Colline 92213 Saint Cloud France and RELIANT PHARMACEUTICALS, LLC 110 Allen Road Liberty Corner, New Jersey 07938 United States EXECUTION COPY

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CONFIDENTIAL THIS DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT, dated as of May 7, 2001, by and among ETHYPHARM S.A., a corporation organized under the laws of France, with its principal offices at 194 Bureaux de la Colline, 92213 Saint Cloud, France, ETHYPHARM INDUSTRIES S.A., a corporation organized under the laws of France, with its principal offices at 194 Bureaux de la Colline, 92213 Saint Cloud, France (Ethypharm, S.A., Ethypharm Industries, S.A., together with their respective subsidiaries and Affiliates, collectively, "ETHYPHARM"), and RELIANT PHARMACEUTICALS, LLC, a limited liability company organized under the laws of the State of Delaware, with its principal offices at 110 Allen Road, Liberty Corner, New Jersey 07938, United States of America ("RELIANT"). Capitalized terms used herein without definition shall have the meanings specified in Section 1 hereof. WITNESSETH THAT: WHEREAS, ETHYPHARM is engaged in the development of new formulations of pharmaceutical specialties and, in particular, is the owner of, and has the right to grant licenses with respect to, certain Know-How and Intellectual Property (as hereinafter defined) used in connection with the development, formulation, manufacture, encapsulation, packaging and otherwise related to the Product (as hereinafter defined); WHEREAS, ETHYPHARM wishes to grant to RELIANT an exclusive license, with the right to sublicense, to such Intellectual Property in the Territory (as hereinafter defined) in relation with the Product developed by ETHYPHARM, and RELIANT is willing to accept such a license on the terms and conditions set forth hereinafter; and WHEREAS, the parties desire to set forth herein, among other things, certain agreements regarding the product development, supply and manufacturing obligations of Initials:

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ETHYPHARM to RELIANT in respect of the Product and the clinical development, licensing, purchasing and marketing obligations of RELIANT to ETHYPHARM in respect of the Product, Intellectual Property and Know-How. NOW, THEREFORE, in consideration of the agreements and covenants hereinafter set forth and intending to be legally bound hereby, the parties hereto covenant and agree as follows: 1. DEFINITIONS 1.1 "Act" shall mean the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §301 et seq., and the regulations promulgated thereunder, in each case as hereafter amended from time to time, and similar legislation in other countries of the Territory. 1.2 "Additional Manufacturing Facility" shall have the meaning specified in Section 5.4. 1.3 "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 2

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primarily for the benefit of such lineal descendants, entities controlled by such lineal descendants and/or trust for their benefit. 1.4 "API" or "Active Pharmaceutical Ingredient" means the raw non-micronized fenofibrate used in the Product manufactured by a party other than ETHYPHARM or any of its Affiliates. 1.5 "Applicable Laws" means all laws, statutes, codes, treaties, ordinances, judgments, decrees, directives, injunctions, orders of any court, arbitrator or Governmental Authority, rules, regulations, interpretations, authorizations and Applicable Permits of any Governmental Authority applicable to any of the parties hereto, the transactions contemplated hereby and/or the Product. 1.6 "Applicable Permits" means any waiver, exemption, variance, permit, license, authorization, consent, certification, registration or similar approval (including, without limitation, any NDA), including, without limitation, product registrations by or of any Governmental Authority required to be obtained or maintained under Applicable Laws in connection with the formulation, development, registration, manufacture, packaging, labeling, import, export, shipment, receipt, storage, use, pricing or sale of the Product, regardless of the formulation or dosage form thereof, and any ingredient thereof. 1.7 "Approval Date" means, with respect to a particular country in the Territory, the date on which all Applicable Permits necessary for the commercial sale and pricing of the Product by or on behalf of RELIANT in such country have been issued and are in effect. 1.8 "Audit" shall have the meaning specified in Section 7.7. 3

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1.9 "Bulk Product Form" shall mean the Product in such form which is ready for incorporation by or on behalf of RELIANT into Finished Dosage Form or such other form as may be sold commercially by RELIANT in the Territory. 1.10 "Business Day" means any day except Saturday, Sunday and any day which shall be a federal legal holiday in the United States or a day on which banking institutions in the State of New Jersey or Paris, France are authorized or required by law or other government action to close. 1.11 "cGMP" shall mean current Good Manufacturing Practices as in effect under the Act from time to time and similar regulations in other countries under Applicable Laws. 1.12 "CMC" shall mean the Chemistry and Manufacturing Controls section of the IND or NDA, as applicable, as then in effect. 1.13 "Combination Product" shall have the meaning specified in Section 6.10. 1.14 "Competing Dosage Form" shall mean a fenofibrate monotherapy product marketed by or on behalf of RELIANT other than the Product in a formulation and dosage form that is substantially similar or identical to the Product. For the purposes of this Agreement, no Combination Product shall be considered a Competing Dosage Form. 1.15 "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, 4

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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. 1.16 "Contract Manufacturing Agreement" shall have the meaning specified in Section 5.5. 1.17 "Delivery Forecast" shall have the meaning specified in Section 7.4. 1.18 "DMF" shall mean the Drug Master File (together with all subsequent submissions, supplements and amendments thereto, and any materials, documents or information referred to or relied upon thereby) in the United States and any similar files in other countries of the Territory that relate to the Product. 1.19 "ETHYPHARM" shall have the meaning specified in the Preamble. 1.20 "ETHYPHARM Indemnified Claims" shall have the meaning specified in Section 6.4. 5

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1.21 "ETHYPHARM Indemnified Parties" shall have the meaning specified in Section 13.2. 1.22 "ETHYPHARM Infringement Indemnitees" shall have the meaning specified in Section 6.5. 1.23 "Event of Default" shall have the meaning specified in Section 12.1. 1.24 "Exception Notice" shall have the meaning specified in Section 7.6. 1.25 "FDA" shall mean the Food and Drug Administration in the United States and similar Governmental Authorities in other countries within the Territory, including any successor agencies performing comparable functions. 1.26 "Finished Dosage Form" means the Product in the form of single dose capsules containing the formulation and dosage of API as developed by ETHYPHARM and such quantity and type of excipients specified in the Specifications, which shall be labeled and packaged (in high density polyethylene (HDPE) bottles and/or blister packs as specified by RELIANT) such that it is ready for immediate marketing, sale or other distribution by RELIANT. 1.27 "Governmental Authority" means any international, national, domestic, foreign, regional, local or other governmental or regulatory body, agency, authority, court or other authorized Person, including, without limitation, all such Persons having jurisdiction over the formulation, development, registration, manufacture, packaging, labeling, import, export, shipment, storage, use, pricing or sale of the Product, regardless of the formulation or dosage form thereof, or health and safety matters generally. 1.28 "IND" shall mean an Investigational New Drug Application under the Act (together with all subsequent submissions, supplements and amendments thereto, 6

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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. 1.29 "Initial Term" shall have the meaning specified in Section 11.1. 1.30 "Intellectual Property" shall mean all patents (including, without limitation, the Patents), copyrights, trademarks, service marks, service names, trade names, internet domain names, e-mail addresses, applications or registrations for any of the foregoing, or extensions, renewals, continuations or re-issues thereof, or amendments or modifications thereto, brandmarks, brand names, trade dress, labels, logos, know-how (including, without limitation, the Know-How), show-how, technical and non-technical information, trade secrets, formulae, techniques, sketches, drawings, models, inventions, designs, specifications, processes, apparatus, equipment, databases, research, experimental work, development, pharmacology and clinical data, software programs and applications, software source documents, third-party licenses, and any similar type of proprietary intellectual property right vesting in the owner and/or licensee thereof pursuant to the applicable laws or regulations of any relevant jurisdiction or under any applicable license or contract, whether now existing or hereafter created, together with all modifications, enhancements and improvements thereto. 1.31 "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 7

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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. 1.32 "Launch Date" shall mean, with respect to each country in the Territory, the first date RELIANT receives proceeds from the commercial sale of the Product in such country. 1.33 "License" shall have the meaning specified in Section 3.1. 1.34 "License Exclusion Transaction" shall have the meaning specified in Section 3.1. 1.35 "LET Notice" shall have the meaning specified in Section 3.2. 1.36 "Make-Whole Payment" shall have the meaning specified in Section 3.4. 1.37 "Minimum Annual Sales" shall have the meaning specified in Section 3.4. 1.38 "NDA" shall mean any 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 approval to market, sell or otherwise distribute the Product, in any formulation or dosage form, in the United States, and similar applications or filings in the countries within the Territory. 1.39 "Net Royalties" means royalties payable to ETHYPHARM pursuant to the terms of this Agreement, net of any Taxes required to be withheld therefrom. 1.40 "Net Sales" means the aggregate amounts invoiced by RELIANT for sales of the Product produced using ETHYPHARM Intellectual Property to independent and 8

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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. 1.41 "Nonparticipating Party" shall have the meaning specified in Section 6.8. 1.42 "Patents" shall mean any issued patents and patent applications (including, without limitation, any applications or registrations therefor, extensions, renewals, continuations or re-issues thereof, or amendments or modifications thereto) that are currently owned or hereafter acquired or applied for by ETHYPHARM, which would be infringed by the formulation, development, registration, manufacture, packaging, labeling, import, export, receipt, shipment, storage, use, pricing or sale of the Product or any ingredient thereof in the Territory, but for the rights granted to RELIANT by ETHYPHARM under this Agreement, including but not limited to those patents and patent applications set forth on Schedule 1.42 attached hereto (as may such schedule shall be amended from time to time). 1.43 "Person" means any individual, partnership, association, joint venture, corporation, limited liability company, trust or Governmental Authority or other entity. 1.44 "Product" means a product composed of or containing micronized fenofibrate, in any dosage form, including encapsulated or bulk beads, granules or similar 9

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presentations, including, without limitation, the fenofibrate product developed by ETHYPHARM for RELIANT pursuant to this Agreement and the Product Development Program. 1.45 "Product Development Program" shall have the meaning specified in Section 2.1. 1.46 "Recall" shall have the meaning specified in Section 7.9. 1.47 "Regulatory Applications" shall have the meaning specified in Section 2.4. 1.48 "RELIANT" shall have the meaning specified in the Preamble. 1.49 "RELIANT Clinical Data" shall have the meaning specified in Section 2.2. 1.50 "RELIANT Indemnified Claims" shall have the meaning specified in Section 6.5. 1.51 "RELIANT Indemnified Parties" shall have the meaning specified in Section 13.1. 1.52 "RELIANT Infringement Indemnitees" shall have the meaning specified in Section 6.4. 1.53 "Specifications" means the pharmaceutical formulation, manufacture, delivery, packaging, labeling, import, export, storage, receipt and shipment specifications for the Product (including Product in Bulk Product Form and Finished Dosage Form) and any excipients set forth on Exhibit A attached hereto (which Exhibit A may be amended or changed from time to time upon the agreement of the parties). 1.54 "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, 10

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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). 1.55 "Term" shall have the meaning specified in Section 11.1. 1.56 "Territory" means: (a) the United States of America, its territories and possessions including without limitation, Puerto Rico; (b) the Caribbean (including, without limitation, The Bahamas); (c) Mexico; and (d) Canada. 1.57 "Third Party Infringement" shall have the meaning specified in Section 6.8. 2. PRODUCT DEVELOPMENT PROGRAM; CLINICAL DATA; PRODUCT REGISTRATION 2.1 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 11

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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. 2.2 Ownership of Clinical Data. Subject to the provisions of Section 2.3, all preclinical, clinical, technical and other information relative to the clinical program, data, analyses, studies or similar information (including, without limitation, all Intellectual Property) generated or developed by or on behalf of the parties after the date hereof as a result of or in connection with the Product Development Program and the clinical trials conducted by RELIANT hereunder and thereunder (collectively, the "RELIANT Clinical Data"), shall be owned exclusively by RELIANT. 2.3 ETHYPHARM's Right to RELIANT Clinical Data. The parties agree, that following the issuance of an NDA for the purpose of licensing the Product and subject to the terms and conditions of this Agreement, ETHYPHARM shall have access to the RELIANT Clinical Data for use outside the Territory on the basis of terms and conditions to be negotiated in good faith between the parties; provided, however, as consideration for providing ETHYPHARM access to such RELIANT Clinical Data, such terms and conditions shall provide that RELIANT shall be entitled to receive [***] percent ([***]%) of any non-refundable license, royalty, fee and/or milestone payment received by, ETHYPHARM by or from any third party licensee of the Product. For the avoidance of doubt, the parties acknowledge and agree that ETHYPHARM shall have no rights in or to any RELIANT Clinical Data until the issuance of the final NDA or in the event that that the NDA is [***]:Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 12

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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. 2.4 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 13

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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). 2.5 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 14

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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. 2.6 Compliance of Specifications. The Specifications shall at all times be in compliance with the requirements of the Act and, in particular, an NDA applicable to the Product, such that RELIANT shall be entitled to market, sell and distribute the Product in the Territory, and the parties agree to make any changes to the Specifications as may be required to ensure such compliance. 3. GRANT OF LICENSE 3.1 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, 15

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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"). 3.2 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, 16

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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 reoffering such opportunity to RELIANT pursuant to this Section 3.2. 3.3 Sublicenses. RELIANT shall have the right to sublicense any and all of the rights granted pursuant to this Agreement, in whole or in part, to one or more Persons; provided, however, that RELIANT shall promptly (a) advise ETHYPHARM of the identity of any such sublicensee; and (b) provide ETHYPHARM with a copy of the sublicense agreement to establish that such sublicensee has been informed of the obligations under this Agreement. Notwithstanding the foregoing, RELIANT shall not be required to disclose to ETHYPHARM the amount or structure of any royalty or other payments due to RELIANT from any such sublicensees. RELIANT agrees that it shall require any sublicensees of any of its rights hereunder to preserve the confidentiality of any ETHYPHARM Intellectual Property or Confidential Information to the extent RELIANT is required to do so under this Agreement. 17

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3.4 Minimum Annual Sales Requirement; Conversion to Non-Exclusive License. In order to maintain exclusivity of the License granted in Section 3.1, RELIANT shall be required to reach minimum annual sales of capsules containing Product ("Minimum Annual Sales") in the United States and Canada as set forth immediately below for the year ending on the anniversary of the applicable Launch Date in such country (subject to adjustment for introduction of generic competing products in the Territory as described below): Minimum Annual Sales ­ United States
Launch Date Anniversary Minimum Number of Capsules to Be Sold

[***] [***] [***]

[***] [***] [***]

Minimum Annual Sales ­ Canada
Launch Date Anniversary Minimum Number of Capsules to Be Sold

[***] [***] [***]

[***] [***] [***]

No Minimal Annual Sales requirements shall apply after the [***] anniversary of the applicable Launch Date or in respect of any sales of the Product in outside of the United States and Canada. Should RELIANT fail to reach the applicable Minimum Annual Sales target during any applicable year, 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 meet the Minimum Annual Sales target; provided, however, that RELIANT shall have the option, but not the obligation, to make an additional payment (the "Make-Whole Payment"), in addition to any other payments due to ETHYPHARM under Section 9.1 in respect of sales of the Product in such country for said year, such that ETHYPHARM receives an aggregate amount for sales of Product in such country for said year that is not less than the amount ETHYPHARM would have received under this Agreement had RELIANT achieved the applicable Minimum Annual Sales target in such country for said year, in which case ETHYPHARM shall have no right to convert the License to a non-exclusive license in such country. For the purpose of calculating the amount of the Make-Whole Payment, RELIANT shall use the [***] in such country for said year. For the avoidance of doubt, the parties agree and acknowledge that sales of the Product by RELIANT's sublicensees shall be included for the purposes of determining whether the applicable Minimum Annual Sales target has been satisfied. The parties agree that in the event that any generic products that compete with the Product are introduced in the Territory during the period while any Minimum Annual Sales targets remain in effect, the applicable Minimum Annual Sales targets shall be reduced by [***] percent ([***] %) in the [***] (pro rated for generic introductions in the middle of the applicable year), by [***] percent ([***] %) in [***] and by [***] percent ([***] %) for [***] . 3.5 Competing Dosage Forms. RELIANT may not, within [***] years of the first Launch Date in the Territory, develop, have developed, promote, distribute or market any [***]:Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 18

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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. 4. COMPENSATION ­ LICENSE FEES AND MILESTONE PAYMENTS 4.1 License Fees. In consideration of the services by ETHYPHARM to research and develop the Product, pursuant to the License and other rights granted hereunder, RELIANT shall pay to ETHYPHARM license fees, up to an aggregate amount of US$[***] , as follows: (a) US$[***] upon full execution by the parties of this Agreement; (b) US$[***] within five (5) Business Days of the acceptance for filing by the FDA of RELIANT's NDA for the marketing and sale by RELIANT of the Product in the United States, which NDA shall contain all sections thereof and other supporting documentation required to be prepared and delivered by ETHYPHARM pursuant to Section 2.5 hereof; [***]:Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 19

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(c) US$[***] if and when cumulative Net Sales (measured from the first Launch Date) exceed US$[***] , which amount shall be payable at such time as the next payment is due to ETHYPHARM in respect of Net Sales pursuant to Section 9.1 hereof. 4.2 Milestone Payments. In addition to the license fees set forth above, RELIANT shall pay to ETHYPHARM milestone payments following the delivery and acceptance of materials necessary for clinical development of the Product, the filing of the Regulatory Applications and the issuance of the Applicable Permits required for RELIANT to market and sell the Product in the Territory, up to an aggregate amount of US$[***] , as follows: (a) US$[***] within five (5) Business Days following receipt and acceptance by RELIANT of the first delivery of validated clinical trial supplies of Product from ETHYPHARM pursuant to Section 5.1 hereof; (b) US$[***] following receipt and acceptance by RELIANT of sufficient quantities of the Product in Finished Dosage Form batches from ETHYPHARM necessary to satisfy the requirements of the Act (including, without limitation, the NDA and other applicable permits) and to obtain regulatory approval to commence marketing of the Product in the United States, said sum being payable in three (3) installments as follows: (i) US$[***] within five (5) Business Days of RELIANT's receipt and acceptance of the first delivery of the Product in Finished Dosage Form pursuant to Section 5.2 hereof;

[***]:Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 20

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(ii) (iii)

US$500,000 within five (5) Business Days of issuance to RELIANT of the NDA by the FDA for marketing the Product in the United States; and US$500,000 within five (5) Business Days of the six (6) month anniversary of the first Launch Date in the Territory.

4.3 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 21

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opportunity to resolve or mitigate, any problem or other issue that arises with respect to the Product Development Program and/or the NDA. 4.4 Refund. Any payments made to ETHYPHARM pursuant to Sections 4.1 or 4.2 above which are made prior to the Approval Date for the marketing and sale of the Product by RELIANT in the United States shall be refunded in full by ETHYPHARM to RELIANT within five (5) Business Days following RELIANT's notice to ETHYPHARM of the rejection of the NDA by the FDA, or an order of "non-approval" or similar FDA comment, if such rejection order or comment is due to any acts or omissions of ETHYPHARM or any of its suppliers, employees, agents or Affiliates, including, but not limited, to any acts or omissions that consist of or result in one or more of the following: (a) lack of Product stability; (b) lack of documentation regarding Product stability; (c) inadequacies in the DMF, the CMC or any other materials prepared or provided by or on behalf of ETHYPHARM that are included in the Regulatory Applications; and/or (d) failure to comply with any Applicable Laws or Applicable Permits regarding the manufacture or packaging of the Product, in any formulation or dosage form, including, without limitation, failure to comply with cGMP requirements, or properly maintain any documentation required under Applicable Law. In the event of any of the foregoing, RELIANT shall promptly notify ETHYPHARM of any such rejection of the NDA and the reason therefor, and 22

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shall provide to ETHYPHARM copies of relevant documents in support of its request for a refund as may reasonably be requested by ETHYPHARM. The parties agree that, in the event that, following a rejection of the NDA, RELIANT continues to intend to market the Product outside of the United States they shall negotiate in good faith a reduction of the refund (i.e., the amount entitled to be retained by ETHYPHARM) under this Section 4.4. 4.5 Method of Payment. All payments required to be paid under this Agreement by RELIANT to ETHYPHARM, or ETHYPHARM to RELIANT, shall be paid in United States dollars by wire transfer of immediately available funds to a dollar-denominated account located in the United States pursuant to written payment instructions, which shall be delivered to by the party entitled to such payment at least five (5) Business Days prior to the date such payment is due. Such payment shall be deemed to have been made upon the issuance of a federal reference number for the wire transfer of said funds. 5. DELIVERY OF PRODUCT FOR CLINICAL AND REGULATORY PURPOSES; PRODUCT LAUNCH; ADDITIONAL MANUFACTURING FACILITY 5.1 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 23

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hereto; and (b) delivered by ETHYPHARM within thirty (30) days of ETHYPHARM's receipt of RELIANT's order therefor. 5.2 Registration Batches. ETHYPHARM shall manufacture, deliver and sell to RELIANT such quantities of full commercial scale batches of the Product, in such formulations and dosage forms as requested by RELIANT, determined by RELIANT to be necessary to satisfy requirements under Applicable Law or Applicable Permit (including, without limitation, in connection with the filing and approval of an NDA with the FDA) to market the Product in the United States. All Product, in whatever formulation, for use by RELIANT to satisfy such requirements 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. 5.3 Launch and Promotion of the Product. RELIANT shall use its commercially reasonable efforts to commence commercial sales of the Product in the United States within a reasonable time and in any event not later than six (6) months after receipt of the Applicable Permits are issued. For a period of three (3) years following the first Launch Date in the United States, RELIANT shall use its commercially reasonable efforts to promote the Product utilizing a sales force consisting of at least [***] sales representatives. In the event that RELIANT does not use its commercially reasonable efforts to commence commercial sales of the Product within the six (6) month period specified herein, 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 use its [***]:Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

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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). 5.4 Additional Manufacturing Facility. On or prior to the first Launch Date of the Product in the Territory, ETHYPHARM shall establish, validate and certify an additional manufacturing facility for the Product, which facility may be owned by ETHYPHARM or a third party contract manufacturer (such facility, the "Additional Manufacturing Facility"). ETHYPHARM shall certify in writing to RELIANT that the Additional Manufacturing Facility (and, as applicable, any third party contract manufacturer): (i) has the requisite capacity to satisfy ETHYPHARM's production, packaging and delivery obligations, and to meet RELIANT's order requirements, hereunder with respect to the Product in accordance with the Specifications and the terms and conditions of this Agreement; (ii) complies and will comply with all Applicable Laws and holds all Applicable Permits necessary for the manufacture and packaging of the Product in compliance with cGMP; and (iii) has and will have the irrevocable right to use all Intellectual Property and Confidential Information of ETHYPHARM necessary to manufacture and package the Product in any formulation or dosage form required

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hereunder, in accordance with the Specifications and the terms and conditions of this Agreement. 5.5 RELIANT Third-Party Beneficiary Rights. In the event that ETHYPHARM contracts with any third party (other than RELIANT or any of RELIANT's Affiliates) to establish the Additional Manufacturing Facility and to provide the manufacturing services required under Section 5.4 hereof (such contract, a "Contract Manufacturing Agreement"): (a) ETHYPHARM shall deliver to RELIANT a true and complete copy of such Contract Manufacturing Agreement promptly following the execution thereof; (b) such Contract Manufacturing Agreement shall explicitly provide that RELIANT is a third party beneficiary thereof with the right to enforce the provisions thereof for its benefit; and (c) such Contract Manufacturing Agreement shall contain such terms and conditions that are consistent with those contained herein (including, without limitation, the obligation to manufacture, package, sell and deliver Product to RELIANT, and the right of RELIANT to conduct an audit an inspection of the Additional Manufacturing Facility pursuant to Section 7.10 hereof). The parties agree and acknowledge that the foregoing requirements are necessary in order that RELIANT may be assured that it will continue to be supplied with the Product in accordance with the terms and conditions of this Agreement, and meet its contractual obligations to various third-parties. Notwithstanding the foregoing, RELIANT shall not be required to make any payment or render any performance hereunder to any Person other than ETHYPHARM, except as RELIANT may agree in writing. 26

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6.

OWNERSHIP AND USE OF INTELLECTUAL PROPERTY; DEVELOPMENT OF COMBINATION PRODUCTS 6.1 Ownership. Subject to the terms hereof, including, without limitation, the License and other rights granted by ETHYPHARM to RELIANT hereunder, all existing and future Intellectual Property of the parties with respect to the Product shall be owned as follows: (a) other than as provided below or elsewhere in this Agreement, all Intellectual Property owned by any party hereto on the date hereof shall continue to be owned by such party; (b) any Intellectual Property developed, created or discovered solely by ETHYPHARM and subject to the license granted hereunder during the Term of this Agreement relating to the Product and its manufacturing shall be owned by ETHYPHARM; and (c) any Intellectual Property developed, created or discovered by or on behalf of RELIANT during the Term of this Agreement relating to any of the clinical development and methods of use of the Product, in any formulation or dosage form, and any Intellectual Property that is otherwise developed by RELIANT shall be owned by RELIANT. Each party agrees to execute and deliver to the party that owns or is entitled to own any Intellectual Property hereunder, such instruments of transfer and assignment as may be requested by the owner party to vest fully in such party the ownership rights in said Intellectual Property; provided, however, that each party hereto shall be entitled, during the Term of this Agreement, to use and practice any and all Intellectual Property owned by the other party of the types 27

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described in foregoing clauses (a), (b) and (c), without additional payment or royalty, for purposes not inconsistent with this Agreement and in accordance with the terms and conditions hereof. In any event, RELIANT may not use ETHYPHARM's Intellectual Property to apply for a patent outside the Territory. Each party shall be free to use and practice its own Intellectual Property in any application not inconsistent with the terms of this Agreement without the consent of the other and without an obligation to notify the other party of such intended use or to pay royalties or other compensation to the other by reason of such use during the Term of this Agreement and thereafter. 6.2 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 28

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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. 6.3 Notice of Infringement. If either party shall learn of (a) any claim or assertion that the manufacture, use or sale of the Product under, or any use of Intellectual Property contemplated by, this Agreement, or any other action taken by either party in performance of its obligations hereunder infringes, misappropriates or otherwise violates the Intellectual Property rights of any third party, or (b) the actual or threatened infringement, misappropriation or other violation by any third party of the Intellectual Property rights of any party hereto that are the subject of this Agreement, then the party becoming so informed shall as soon as reasonably practicable, but in all events within fifteen (15) Business Days thereof, notify the other party to this Agreement of such claim or assertion, or actual or threatened infringement, misappropriation or other violation. 6.4 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 29

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SEC Info - Reliant Pharmaceuticals/Inc - S-1/A - On 8/5/05 - EX-10.29 Case 1:08-cv-00126-SLR Document 15-3 Filed 05/13/2008

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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 indemnif