CONFIDENTIAL TREATMENT REQUESTED [***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION....
Exhibit 10.1
CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
dated March 26, 2003
by and between
Flamel Technologies, S.A.
and
SB Pharmco Puerto Rico Inc.
CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
Table of Contents
Page | ||||||
ARTICLE 1 | DEFINITIONS | 1 | ||||
ARTICLE 2 | LICENSE GRANTS | 6 | ||||
ARTICLE 3 | PAYMENTS | 6 | ||||
ARTICLE 4 | DEVELOPMENT, COMMERCIALIZATION AND SUPPLY | 11 | ||||
ARTICLE 5 | INTELLECTUAL PROPERTY | 13 | ||||
ARTICLE 6 | REPRESENTATIONS AND WARRANTIES | 16 | ||||
ARTICLE 7 | CONFIDENTIALITY AND EXCHANGE OF INFORMATION | 18 | ||||
ARTICLE 8 | INDEMNIFICATION | 20 | ||||
ARTICLE 9 | TERM AND TERMINATION | 22 | ||||
ARTICLE 10 | MISCELLANEOUS | 24 | ||||
SCHEDULE 1.14 | FLAMEL PATENT RIGHTS | 29 | ||||
SCHEDULE 1.30 | FLAMEL WORK PLAN | 30 | ||||
SCHEDULE 4.6 | Existing Studies and Delivery of Clinical Supplies of Small Particle Micropump | 37 | ||||
SCHEDULE 4.7 | Key Supply Terms | 38 | ||||
SCHEDULE 6.2 | Exceptions To Representations And Warranties | 41 | ||||
SCHEDULE 7.3 | Press Release | 42 | ||||
SCHEDULE 8.4 | Flamel Insurance | 44 |
-i- |
CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
This License Agreement (the "Agreement"), dated March 26, 2003 is made by and between SB Pharmco Puerto Rico, Inc., a GlaxoSmithKline company organized and existing under the laws of the territory of Puerto Rico, with its principal place of business at Xxxx 000, XX 9.1/Bo. Xxxxxxxxxx, Xxxxx, Xxxxxx Xxxx 00000 (hereinafter, "GSK") and Flamel Technologies, S.A., a corporation organized and existing under the laws of France, with its principal place of business at Parc Club du Moulin a Vent, 00 Xxxxxx xx Xxxxxxx Xxxxxxx Xxxx 00000 Venissieux Cedex, France, (hereinafter, "Flamel") (each a "Party" and collectively, the "Parties").
WHEREAS, Flamel has developed certain proprietary technology related to Flamel Micropump Technology (as defined below);
WHEREAS, GSK and Flamel have undertaken a feasibility study (the "Feasibility Agreement" as defined below) to develop a Formulation (as defined below) by applying the Flamel Micropump Technology to Carvedilol (as defined below and referred to in the Feasibility Agreement the "Molecule");
WHEREAS, Flamel is the owner of all right, title and interest in, or otherwise controls, certain Flamel Patent Rights (as defined below) and Flamel Know-How (as defined below) relating to the use of the Flamel Micropump Technology;
WHEREAS, GSK desires to obtain from Flamel an exclusive license under the Flamel Patent Rights and Flamel Know-How to discover, develop, make, have made, use, market, offer to sell, sell and import the Product (as defined below); and
WHEREAS, Flamel desires to grant to GSK, an exclusive license throughout the world under this Agreement to discover, develop, make, have made, use, market, sell, offer to sell and import the Product throughout the world under the aforesaid Flamel Patent Rights and Flamel Know-How.
NOW, THEREFORE, in consideration of the mutual covenants set forth in this Agreement, GSK and Flamel hereby agree as follows:
ARTICLE
1
DEFINITIONS
1.1. "Affiliate" means any legal entity (such as a corporation, partnership, or limited liability company) that directly or indirectly Controls, is Controlled by or is under common Control with a Party to this Agreement. For the purposes of this definition, the term "Control" means: (i) beneficial ownership of at least fifty percent (50%) of the voting securities of a corporation or other business organization with voting securities (or such lesser percentage required under local jurisdiction); (ii) a fifty percent (50%) or greater interest in the net assets or profits of a partnership or other business organization without voting securities; or (iii) the ability to direct the affairs of any such entity.
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CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
1.2. "Calendar Quarter" means a three (3) month period ending on March 31, June 30, September 30 or December 31.
1.3. "Carvedilol" means (1-(9H-carbazol-4-yloxy)-[[2-2(2-methoxyphenoxy)ethyl] amino]-2-propanol), the compound that is known by the generic name of Carvedilol and including all racemates, chelates, complexes, enantiomers, diastereoisomers, salts, bases, esters, hydrates, solvates, polymorphs, crystal forms, crystal habits, prodrugs, isotopic or radiolabeled equivalents, metabolites, or the like, thereof and all mixtures and any of the foregoing, and compositions comprising Carvedilol.
1.4. "Confidential Information" means (i) any proprietary or confidential information or material in tangible form disclosed by a Party hereunder that is marked as "Confidential" at the time it is delivered to the receiving Party, and/or (ii) proprietary or confidential information disclosed orally hereunder that is identified as confidential or proprietary when disclosed and such disclosure of confidential information is confirmed in writing within a reasonable period of time thereafter by the disclosing Party.
1.5. "Control," "Controls," "Controlled," or "Controlling" means (except with respect to "Affiliate" as defined in Section 1.1) possession of the ability to grant the licenses or sublicenses as provided herein without violating the terms of any license agreement or other arrangement with any Third Party, or any government regulation or statute.
1.6. "Commercially Reasonable Efforts" means efforts and resources comparable to those used by GSK and its Affiliates for a compound or product with similar market or commercialization prospects at a similar stage in its product life cycle, taking into account the stage and risk of development or commercialization of Product, the cost-effectiveness of efforts or resources while optimizing profitability, the competitiveness of alternative compounds or products that are or are expected to be in the marketplace, the scope and duration of patent rights or other proprietary rights related to Product, the profitability of Product and alternative products and other relevant commercial factors.
1.7. "Cost Of Goods Sold" or "COGS" means Flamel's fully allocated cost of manufacturing, comprising all direct costs (including but not limited to, labor, materials, energy, utilities, quality control or other costs incurred directly in the manufacturing of Product that is the active pharmaceutical ingredient thereof) and indirect costs (including but not limited to administrative labor costs, manufacturing facility and equipment maintenance, relevant insurance, and depreciation of manufacturing equipment and manufacturing facilities) specifically allocable to the production and delivery of Product to GSK; such calculation being based upon accepted contract manufacturing industry standards or generally accepted accounting principles.
1.8. "EMEA" means the European Agency for the Evaluation of Medicinal Products or any successor agency thereof performing similar functions.
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CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
1.9. "Effective Date" means the date on which this Agreement is executed.
1.10. "FDA" means the Food and Drug Administration of the United States Department of Health and Human Services, or any successor agency thereof performing similar functions.
1.11. "Feasibility Agreement" means the Feasibility Study Agreement dated April 8, 2002 between SmithKline Xxxxxxx Corporation d/b/a GlaxoSmithKline and Flamel Technologies, S.A., as amended.
1.12. "First Commercial Sale" means the first sale of Product to a Third Party by GSK or its Affiliate(s) or sublicensee(s) in a country in the Territory.
1.13. "Flamel Micropump Technology" means a multiple-dose system containing a large number of microparticles that may be contained in capsule, tablet, orally dispersible, sachet or suspension formulations. It is expected that the microparticles are released in the stomach and pass into the small intestine, where each microparticle operates as a miniature delivery system, releasing the drug at a controlled rate and over an extended period of time.
1.14. "Flamel Patent Rights" means: (i) all patents and patent applications in existence as of the Effective Date or during the Term of this Agreement claiming generically or specifically a product or process using the Flamel Micropump Technology; and (ii) any divisions, continuations, continuations-in-part, reissues, reexaminations, patents of additions, extensions or other governmental actions that extend any of the subject matter of the patent applications or patents in clause (i) above, and any substitutions, confirmations, registrations or revalidations of any of the foregoing, in each case that is owned or Controlled, in whole or part, by license, assignment or otherwise by Flamel as of the Effective Date, or during the Term of the Agreement, to the extent Flamel has the right to license or sublicense such Flamel Patent Rights, and subject to any limitations of any such license or sublicense. The current list of patent applications and patents encompassed within Flamel Patent Rights is set forth in Schedule 1.14, which shall be updated by Flamel on a semi-annual basis during the Term of the Agreement. For the avoidance of doubt, Flamel Patent Rights shall include Flamel-Owned Inventions (as defined in Section 5.1.3).
1.15. "Flamel Know-How" means all ideas, non-public inventions, data, instructions, processes, procedures, formulas, expert opinions and information, including, without limitation, biological, chemical, toxicological, pharmacological, physical and analytical, formulation, clinical, analytical, stability, safety, manufacturing and quality control data and information, in each case, that are necessary or useful for the development, testing, use, manufacture or sale of the Formulation or Product and that is in the possession of and owned or Controlled by Flamel as of the Effective Date or during the Term of this Agreement. Flamel Know-How shall include Flamel-Owned Inventions (as defined in Section 5.1.3), but only to the extent that such are not included in Flamel Patent Rights. Flamel Know-How shall be Confidential Information of Flamel as defined in Section 1.4.
1.16. "Formulation" means any formulation of Carvedilol developed under the Feasibility Agreement.
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CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
1.17. "Full-Time Equivalent" or "FTE" means the effort equivalent to one (1) full-time employee of Flamel working on a specific project or task assigned by GSK under this Agreement, who is qualified to perform such work, based on a total of one thousand, eight hundred and eighty (1,880) hours of work per year, as further explained in Section 3.8 hereof.
1.18. "Licensed Technology" means Flamel Know-How and Flamel Patent Rights.
1.19. "Joint Development Committee" means the Joint Development Committee described in Section 4.5.
1.20. "Major Market" means any one of the following countries: the United Kingdom; France, Spain; Germany; Italy; Japan; or the United States.
1.21. "Marketing Authorization Application" or "MAA" means a Marketing Authorization Application submitted to the EMEA for the purpose of obtaining European Commission approval or any other applications for Registration based on mutual recognition procedure by the Committee for Proprietary Medicinal Products ("CPMP") for the marketing of a Product for the countries located within the EU.
1.22. "Marketing Approval" means the approval of an NDA in the US, the approval of an MAA in the EU, or any corresponding approvals in any other countries of the Territory, including any pricing and reimbursement approvals in any country of the Territory where such approvals are required for commercially reasonable launch of a Product in such country.
1.23. "New Drug Application" or "NDA" means a means a New Drug Application submitted to the FDA to obtain FDA approval for the marketing of a Product in the United States.
1.24. "Net Sales" means the actual invoiced gross sales of Product to Third Parties by GSK, its Affiliates or sublicensees, as recorded by the selling party in accordance with generally accepted accounting principals, less the following to the extent included in the calculation of invoiced sales:
(i) | credited allowances to such Third Party customers for spoiled, damaged, rejected, recalled, outdated and returned Products and for reasonable retroactive price reductions; |
(ii) | freight, transportation, warehousing, storage, postage and insurance invoiced to such Third Party; |
(iii) | the amounts of trade and cash discounts actually allowed, to the extent such trade and cash discounts are specifically allowed on account of the purchase of such Product; |
(iv) | sales taxes, excise taxes, use taxes and import/export duties actually due or incurred in connection with the sales of the Product to any Third Party; |
4 |
CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
(v) | reasonable allowances, adjustments, reimbursements, discounts, chargebacks and rebates granted to Third Parties, including, but not limited to, rebates given to health care organizations or other Third Parties, whether during the actual royalty period or not; |
(vi) | any bona fide payment made by GSK to government agencies with respect to sales of Product in order to be allowed to tender the sale of the Product in a given country in the Territory, and any bona fide payment made by GSK to any Third Parties for assistance provided to GSK in this process; and |
(vii) | actual chargeoffs for bad debt. |
Sales or transfers of Product among GSK, an Affiliate and/or a sublicensee shall be excluded from the computation of Net Sales, and no royalties will be payable on such sales.
1.25. "Product" means any presentation or presentations of Carvedilol that incorporate the Licensed Technology, alone or in combination with other therapeutically active compounds, for the therapeutic or prophylactic treatment of diseases and conditions in humans in any dosage or strength.
1.26. "Term" means the term of this Agreement as set forth in Section 9.1.1.
1.27. "Territory" [***] provided that, should this Agreement expire as to any country or territory pursuant to Section 9.1, or should GSK terminate this Agreement as to any country or territory pursuant to Section 9.4, such country or territory shall no longer be considered within the Territory. As used in this Agreement, "country" shall refer to country or territory, as appropriate.
1.28. "Third Party(ies)" means any party(ies) other than Flamel, GSK, or an Affiliate of either of them.
1.29. "Valid Claim" means either: (i) a claim of an issued or unexpired patent within Flamel Patent Rights that has not been held unenforceable, unpatentable or invalid by a governmental agency or a court of competent jurisdiction in any unappealable or unappealed decision within the time allowed for appeal, and that has not been admitted to be unenforceable, unpatentable or invalid through abandonment, reissue, disclaimer or otherwise, or (ii) a claim of a pending patent application within Flamel Patent Rights that has not been abandoned or finally rejected by Flamel without the possibility of appeal or refiling, such that the claim at issue has been under examination for less than three (3) years; provided, however, that such three (3) year time limit shall not apply if Flamel has exercised diligence in pursuing such pending patent application.
1.30. "Work Plan" means the plan, as described in Sections 4.3 and 4.5, and as forth in Schedule 1.30 to this Agreement, attached hereto and incorporated herein.
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CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
ARTICLE
2
LICENSE GRANTS
ARTICLE
3
PAYMENTS
Milestone Event | Amount | |||
1. | [***] | [***] | ||
2. | [***] | [***] | ||
3. | [***] | [***] | ||
4. | [***] | [***] | ||
5. | [***] | [***] | ||
6 | [***] | [***] | ||
7. | [***] | [***] |
6 |
CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
Milestone Event | Amount | |||
8. | [***] | [***] | ||
9. | [***] | [***] | ||
10. | [***] | [***] |
provided that:
(i) | No Milestone shall be paid more than one time; |
(ii) | Payment shall not be owed for a Milestone Event that is not achieved; |
(iii) | The occurrence of all events leading to Milestones shall be determined by criteria reasonably established by GSK and provided in writing by. GSK to Flamel; |
(iv) | Milestone payments shall be payable by GSK to Flamel within forty-five (45) business days after achievement of the Milestone; and |
(v) | Milestone payments shall be payable when achieved, regardless of the order in which they are achieved. |
Example: In the event Net Sales of the Product equal [***], GSK shall pay a royalty [***], calculated as follows: [***] multiplied by [***], plus [***] multiplied by [***], plus [***] multiplied by [***].
7 |
CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
3.7. Third Party Fees or Royalties.
(a) Flamel shall be fully responsible for obtaining a Third Party license and for the payment of any additional royalties, license fees, milestones and any and all other payments due to Third Parties where:
(i) | the use, development, manufacture, marketing, selling or importing of Product under Licensed Technology is deemed by a court of competent jurisdiction to infringe a claim of a patent(s) owned or controlled by a Third Party in any given country of the Territory and Flamel or GSK licenses such patent(s) in settlement of such claims; and |
(ii) | both Parties agree, or it is determined by outside counsel approved by both Parties, that it is necessary for Flamel to take a license to a Third Party and to pay royalties or other fees to such Third Party to obtain a license to practice any Third Party's rights in order to manufacture, use, commercialize or develop a Product under the Licensed Technology in any given country of the Territory. |
8 |
CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
(b) If GSK and Flamel together have a reasonable belief that a Third Party may assert a claim or right against GSK or Flamel with respect to the Licensed Technology that may result in an infringement claim being brought or asserted by such Third Party with respect to the Licensed Technology, then in such event, GSK may, or may request Flamel to, obtain a license or other settlement with such Third Party, and if GSK obtains such a license, GSK may offset the costs of such royalties or settlement amounts against payments otherwise due Flamel. If Flamel obtains such a license, Flamel will bear all costs associated with such license. If GSK alone has a reasonable belief that a Third Party may assert a claim or right against GSK or Flamel with respect to the Licensed Technology that may result in an infringement claim being brought or asserted by such Third Party with respect to the Licensed Technology, but Flamel does not share such belief, GSK may still obtain a license or other settlement with such Third Party at GSK's sole expense and GSK shall be entitled to submit the matter to arbitration. If the arbitrator determines that the manufacture, use, commercialization or development of Product under the Licensed Technology impinges upon the intellectual property rights of any Third Party such that it is necessary for Flamel and/or GSK to pay royalties or other fees to such Third Party to obtain a license to practice any Third Party's rights in order to manufacture, use, commercialize or develop a Product under the Licensed Technology in any given country of the Territory, then GSK shall be entitled to offset one hundred percent (100%) of the costs of associated with such license or settlement against payments otherwise due Flamel. For the avoidance of doubt, if GSK seeks a license to the Third Party technology that is solely a gastro-retentive technology, then the costs of such license will be borne solely by GSK.
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CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
Bank: | Citibank F.S.B. |
ABA Number: | 000000000 |
Account Name: | Flamel Technologies, S.A. |
Account Number: | 6678 8404 |
GSK shall use its reasonable efforts to notify Flamel as to the date and amount of any such wire transfer to Flamel at least two (2) business days prior to such transfer.
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CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
3.13. Financial Records and Audits.
(a) Flamel's Right to Audit. Flamel, at its own cost, through an independent auditor reasonably acceptable to GSK, may inspect and audit the records of GSK pertaining to the sale of Product and any estimated or actual royalties due to Flamel under Section 3.3. GSK shall provide such auditors with access to the records during reasonable business hours. Such access need not be given to any such set of records more often than once each calendar year, or more than three (3) years after the date of any report to be audited, and the auditors shall report to Flamel only the amount of royalty due, based on good faith estimates of Net Sales. Flamel shall provide GSK with written notice of its election to inspect and audit the records related to the royalty due hereunder not less than thirty (30) days prior to the proposed date of review of GSK's records by Flamel's auditors. GSK shall maintain sufficient records to permit the inspection and auditing permitted hereunder for three (3) years after the date of each respective reporting period. GSK shall prepare its records and reports according to the generally accepted accounting principles of the United Kingdom. The auditor's review shall be limited to determining whether a good faith estimate was used in the royalty calculation, and shall not be based upon whether such estimate was, in fact subsequently determined to be less than the actual Net Sales. Should the auditor find any underpayment of royalties paid as a result of such quarterly estimates not being conducted in good faith, GSK shall promptly pay Flamel the amount of such underpayment, plus interest at the rate of [***] per month or portion thereof on the amount of any underpayment from the date payment was due, and shall reimburse Flamel for the cost of the audit should such underpayment equal or exceed [***] of royalties paid during the time period audited. Should the auditor find any underpayment of royalties based upon the reconciled annual Net Sales, GSK shall promptly pay Flamel the amount of such underpayment, plus interest at the rate of [***] per month or portion thereof on the amount of any underpayment from the date payment was due, and shall reimburse Flamel for the cost of the audit should such underpayment equal or exceed [***] of royalties paid during the time period audited.
ARTICLE
4
DEVELOPMENT, COMMERCIALIZATION AND SUPPLY
11 |
CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
12 |
CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
ARTICLE
5
INTELLECTUAL PROPERTY
13 |
CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
(a) GSK shall have the first right, using in-house or outside legal counsel selected at GSK's sole discretion, to prepare, file, prosecute, maintain and extend patent applications and patents concerning all such GSK Owned Inventions in countries of GSK's choice throughout the Territory, for which GSK shall bear the costs relating to such activities which occur at GSK's request or direction. GSK shall solicit Flamel's advice and review of the nature and text of any such patent applications to the extent such are related to the Flamel Micropump Technology and important prosecution matters related thereto in reasonably sufficient time prior to filing thereof, and GSK shall take into account Flamel's reasonable comments related thereto.
(b) Flamel shall have the first right, using in-house or outside legal counsel selected at Flamel's sole discretion, to prepare, file, prosecute, maintain and extend patent applications and patents concerning all such Flamel Owned Inventions in countries of Flamel's choice throughout the Territory, for which Flamel shall bear the costs. Flamel shall solicit GSK's advice and review of the nature and text of such patent applications to the extent such are related to the Product or the Formulation and important prosecution matters related thereto in reasonably sufficient time prior to filing thereof, and Flamel shall take into account GSK's reasonable comments related thereto.
14 |
CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
(c) If Flamel, prior or subsequent to filing patent applications on any Flamel Patent Rights that are owned in whole by Flamel and are necessary or reasonably related to the Formulation and/or the Product and Flamel elects not to file, prosecute or maintain such patent applications or ensuing patents or claims encompassed by such patent applications or ensuing patents in any country of the Territory, Flamel shall give GSK notice thereof within a reasonable period prior to allowing such patent applications or patents or such claims encompassed by such patent applications or patents to lapse or become abandoned or unenforceable, and GSK shall thereafter have the right, at its sole expense and for Flamel's benefit, to prepare, file, prosecute and maintain patent applications and patents or divisional applications related to such claims encompassed by such patent applications or patents concerning all such inventions and discoveries in countries of its choice throughout the world.
(d) Each of Flamel and GSK shall hold all information it presently knows or acquires under this Section that is related to all such patents and patent applications as confidential and subject to the provisions of Article 7 of this Agreement.
(e) Each Party shall cooperate with the other as reasonably requested to effect the provisions of this Section 5.3.
15 |
CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
ARTICLE
6
REPRESENTATIONS AND WARRANTIES
16 |
CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
(a) Flamel has full Control of the Licensed Technology to grant the rights and licenses granted under Section 2.2, and that Flamel otherwise has the full right and authority to enter into this Agreement;
(b) there are no existing or threatened actions, suits or claims pending against Flame' with respect to the Licensed Technology;
(c) there are no existing or threatened actions, suits or claims pending against Flamel with respect to Flamel's right to enter into and perform Flamel's obligations under this Agreement;
(d) Flamel has not granted, nor will Flamel grant during the Term of this Agreement, any right, license or interest in or to the Licensed Technology that is in conflict with the rights or licenses granted under this Agreement, nor as of the Effective Date, has Flamel encumbered any Flamel Know-How and/or Flamel Patent Rights;
(e) to the best of Flamel's knowledge, there is nothing in any Third Party agreement Flamel has entered into that in any way will limit Flamel's ability to perform all of the obligations undertaken by Flamel hereunder, and that Flamel will not enter into any agreement after the Effective Date under which Flamel would incur any such limitations;
(f) Flamel has no knowledge from which Flamel concludes that the Flamel Patent Rights are invalid or that their exercise would infringe patent rights of Third Parties;
(g) Flamel has no knowledge from which Flamel concludes that the use of Flamel Know-How by GSK as contemplated by this Agreement would constitute a misappropriation of a Third Party's trade secrets;
(h) Flamel has not intentionally omitted to furnish GSK with any information requested by GSK, nor intentionally concealed from GSK, any information in its possession concerning the Licensed Technology or Product, or the transactions contemplated by this Agreement, that would be material to GSK's decision to enter into this Agreement and to undertake the commitments and obligations set forth herein;
(i) Flamel has not intentionally concealed from GSK the existence of any data or information concerning the Licensed Technology or the Product that suggests that there may exist quality, toxicity, safety and/or efficacy concerns that may materially impair the utility and/or safety of Product, or anticipated components thereof; and
(j) to the best of Flamel's knowledge, Flamel has obtained, and will continue to obtain, the assignment of all interests and all rights of any and all Third Parties (including employees) which enable Flamel to grant the license under Section 2.2.
17 |
CONFIDENTIAL TREATMENT REQUESTED
[***] – THE CONFIDENTIAL PORTION OF THIS AGREEMENT WHICH HAS BEEN REDACTED IS MARKEED WITH BRACKETS (“[***]”). THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION.
(a) GSK has the full right and authority to enter into this Agreement;
(b) there are no existing or threatened actions, suits or claims pending against GSK with respect to GSK's right to enter into and perform GSK's obligations under this Agreement, other than as set forth on Schedule 6.2 hereto;
(c) to the best of GSK's knowledge, there is nothing in any Third Party agreement GSK has entered into, other than as set forth on Schedule 6.2 hereto, that, in any way, will limit GSK's ability to perform all of the obligations undertaken by GSK hereunder; and
(d) GSK has not omitted to furnish Flamel with, nor intentionally concealed from Flamel, any information in its possession concerning the transactions contemplated by this Agreement, which would be material to Flames decision to enter into this Agreement and to undertake the commitments and obligations set forth herein.
ARTICLE
7
CONFIDENTIALITY AND EXCHANGE OF INFORMATION
(i) | was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure; |
(ii) | was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party; |
(iii) | became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement; |
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(iv) | was independently developed by the receiving Party without reference to any information or materials disclosed by the disclosing Party; or |
(v) | was subsequently disclosed to the receiving Party by a person other than a Party without breach of any legal obligation to the disclosing Party. |
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ARTICLE
8
INDEMNIFICATION
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ARTICLE 9
9.1. Term and Termination by GSK.
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9.5. General Effect of Termination.
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ARTICLE
10
MISCELLANEOUS
10.1. Governing Law. This Agreement shall be deemed to have been made in the United States, and its form, execution, validity, construction and effect shall be determined in accordance with, and any dispute arising from the performance or breach hereof shall be governed by and construed in accordance with, the laws of the State of New York, without reference to conflicts of laws principles.
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if to GSK: |
GlaxoSmithKline 000 Xxxxxxxxx Xxxx Xxxx xx Xxxxxxx, XX 00000 Attention: Senior Vice President, Business Development Telephone: 000-000-0000 Telecopy: 000-000-0000 | |
with copies to: |
GlaxoSmithKline Corporate Legal Department 0000 Xxxxxxxxxxx Xxxx. Mail Code XX0000 Xxxx xx Xxxxxxx, XX 00000-0000 Attention: Senior Vice President and Assistant General Counsel - R&D Legal Operations Telephone: 000-000-0000 Telecopy: 000-000-0000 | |
if to Flamel: |
Flamel Technologies, S.A. Parc Club du Moulin a Vent 00 Xxxxxx xx Xxxxxxx Xxxxxxx Xxxx 00000 Xxxxxxxxxx Xxxxx Xxxxxx Attention: Xx. Xxxxxx Xxxxx President and Chief Executive Officer Telephone: 000 0000 0000 Telecopy: 334 7278 3435 | |
With a xxx to: |
Flamel Technologies, S.A. 0000 X Xxxxxx, Xxxxx 000 Xxxxxxxxxx, X.X. 00000 Attention: Xxxxxxx X. Xxxxxxx Chief Financial Officer and General Counsel Telephone: 000-000-0000 Telecopy: 000-000-0000 |
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The Remainder of this Page Left Intentionally Blank.
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IN WITNESS WHEREOF, the Parties hereto have caused this License Agreement to be duly executed by their authorized representatives as of the Effective Date.
FLAMEL TECHNOLOGIES, S.A. | SB PHARMCO PUERTO RICO, INC. |
By: | By: | |||
Name: | Xxxxxx Xxxxx | Name: | Xxxx-Xxxxxx Xxxxxxx | |
Title: | President and CEO | Title: | Attorney-in-Fact |
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SCHEDULE 1.14
FLAMEL PATENT RIGHTS
Title | Owner | Country | Dèpôt/Filing Date |
Filing No | Acceptation/ No of Grant |
Date of Grant | ||||||
Microcapsules General principle | FT | Argentina | [***] | [***] | [***] | [***] | ||||||
Microcapsules General principle | FT | Brazil | [***] | [***] | [***] | [***] | ||||||
Microcapsules General principle | FT | Canada | [***] | [***] | [***] | [***] | ||||||
Microcapsules General principle | FT | Europe | [***] | [***] | [***] | [***] | ||||||
Microcapsules General principle | FT | France | [***] | [***] | [***] | [***] | ||||||
Microcapsules General principle | FT | France | [***] | [***] | [***] | [***] | ||||||
Microcapsules General principle | FT | Germany | [***] | [***] | [***] | [***] | ||||||
Microcapsules General principle | FT | Great Britain | [***] | [***] | [***] | [***] | ||||||
Microcapsules General principle | FT | India | [***] | [***] | [***] | [***] | ||||||
Microcapsules General principle | FT | Israel | [***] | [***] | [***] | [***] | ||||||
Microcapsules General principle | FT | Italy | [***] | [***] | [***] | [***] | ||||||
Microcapsules General principle | FT | Japan | [***] | [***] | [***] | [***] | ||||||
Microcapsules General principle | FT | PCT | [***] | [***] | [***] | [***] | ||||||
Microcapsules General principle | FT | South Africa | [***] | [***] | [***] | [***] | ||||||
Microcapsules General principle | FT | Spain | [***] | [***] | [***] | [***] | ||||||
Microcapsules General principle | FT | USA | [***] | [***] | [***] | [***] | ||||||
Microencapsulated Aspirin | FT | Europe | [***] | [***] | [***] | [***] | ||||||
Microencapsulated Aspirin | FT | France | [***] | [***] | [***] | [***] | ||||||
Microencapsulated Aspirin | FT | Japan | [***] | [***] | [***] | [***] | ||||||
Microencapsulated Aspirin | FT | USA | [***] | [***] | [***] | [***] | ||||||
Microencapsulated Aspirin | FT | USA | [***] | [***] | [***] | [***] | ||||||
Micropump II | FT | France | [***] | [***] | [***] | [***] | ||||||
Micropump II | FT | PCT | [***] | [***] | [***] | [***] | ||||||
Mattawan multimicrocapsulaire | FT | France | [***] | [***] | [***] | [***] | ||||||
Metforrnin multimicrocapsulaire | FT | POT | [***] | [***] | ||||||||
Metforrnin bitherapie | FT | France | [***] | [***] | ||||||||
Microcaspsules "delayed release" | FT | France | [***] | [***] | ||||||||
Micropump surenrobe pour compression | FT | France | [***] | [***] |
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SCHEDULE
1.30
FLAMEL WORK PLAN
TECHNICAL PROJECT
Carvedilol MR |
PHASE 2 / Development - Scale-up
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1. | INTRODUCTION |
The goal of this project is to achieve a modified release formulation of Carvedilol (MR) permitting to optimize its efficacy.
FLAMEL has developed two (2) once a day controlled release systems that are tested in a phase I clinical study :
- | the first one, using FLAMEL's Micropump I technology, must continuously release the active during five (5) to ten (10) hours, |
- | the second one, using FLAMEL's Micropump 11 technology, must display a lag time of one (1) to two (2) hours and then release the Carvedilol during five (5) to (8) hours. |
One of the formulations tested should display the targeted releasing profile.
2. | OBJECTIVES |
The main objectives of this project for 2003 are the following:
- | to develop an industrial manufacturing process for the selected modified release system, |
- | to produce batches of Micropump I or Micropump II for the strength range clinical study planned for June 2003, |
- | to produce the clinical batches with the industrial manufacturing equipment , at the appropriate batch size, for the phase ill clinical study planned for January 2004, |
- | to carry out a large scale manufacture (qualification) campaign of selected formulations in conjunction with the preparation of Phase al clinical trial supplies to allow GSK to initiate an official stability program for registration, |
- | to manufacture of phase Di clinical trial supplies will be addressed in the Supply Agreement referenced in Section 4.7 of the Agreement. |
3. | FLAMEL TECHNOLOGIES PROPOSAL |
In 2002, under the terms of the Feasibility Agreement, FLAMEL adapted its Micropump I and II technology to Carvedilol. Initially, Carvedilol free base was used. Subsequently, the Carvedilol phosphate salt was preferred to be tested in a phase I clinical study.
The results of the phase I clinical study will identify a formulation that can be selected for additional clinical and other studies to more fully characterize the pharmacokinetic, pharmacodynamic and pharmaceutical behaviors of the chosen formulation.
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In 2003, FLAMEL will conduct additional formulation, development and optimization work in parallel to the phase II clinical studies in order to determine the suitability of the chosen formulation for possible use in phase III clinical studies.
4. | PROJECT SPECIFICATIONS AND DEFINITIONS |
The specifications of the product corresponding to the formulation chosen will be defined by GSK in collaboration with FLAMEL.
GSK will supply the documentation necessary for the development work.
GSK will supply the Carvedilol phosphate and free base necessary for the development program.
FLAMEL will optimize and validate a manufacturing process to produce a Carvedilol MR formulation at commercial scale.
FLAMEL will develop and validate analytical methodologies to support the selected formulations.
5. | WORK PROGRAM |
The work program is built around several key issues and predefined dates that imply the list of actions given below:
- | choice of the technology and the formulation by mid April 2003; |
- | completion of manufacturing of the additional phase I clinical batches by May 2003; |
- | commencement of additional phase II clinical study by June 2003; |
- | commencement of large-scale manufacture (qualification) campaign for the clinical phase III study supplies on sixty (60) kg batches by July 2003; |
- | delivery of the selected Micropump formulation for manufacture of the phase al clinical batches, including transfer of blending and encapsulation processes and analytical methods, by September 2003; |
- | GO/NO-GO decision on the formulation by November 2003; |
- | commencement of the phase III clinical study by January 2004. |
The following program describes the actions to be performed by FLAMEL:
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5.1 | Laboratory Development. |
The main objective of this work is to supply the information necessary for an NDA and to establish the basic performance characteristics of the formulation and process.
1. | Choice of the excipients. |
2. | Microcapsules optimization. |
3. | Optimization of the final formulation according to the dosage defined. |
4. | Definition of the lots necessary for the in vivo / in vitro (3 profiles) correlation. |
5. | Screening the dissolution test parameters to prove their suitability to the releasing profile tested (ICH guidelines). |
6. | Support to the process development and scale-up. |
7. | Complementary testing on pilot and industrial batches. |
5.2 | Process Development and Pilot Scale-Up. |
The objective is to optimize the manufacturing process at the pilot scale (20 kg/batch) in terms of product quality, performance and yield, to be able to facilitate the scale-up of the process to the industrial equipment.
1. | Process optimization: microcapsules manufacturing (20 kg/batch) |
- | Layering |
- | Carvedilol phosphate yield optimization |
- | Strength of the deposited layer of active Spray-coating |
- | Process parameters optimization |
- | Reproducibility |
- | Microcapsules characterization |
- | Active ingredient (A.I.) content. |
- | SEM characterization of the layer 1 Coating % |
- | Microcapsules distribution size |
- | Physical properties (density , flowing) |
- | Consistency of release rates |
2. | Capsule filling optimization process |
- | Microcapsules lubrication with Mg St, |
- | Capsule filling Characterizations |
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5.3 | Industrial Scale-Up. |
This Section 5.3 will form the basis of the Supply Agreement and will be superceded by the Supply Agreement. The objective is to precisely define the industrial manufacturing equipment needed, to install it and to optimize the different manufacturing stages to achieve the batch size needed for the clinical phase III batches; provided, however, that FLAMEL shall not be entitled to purchase new equipment at the expense of GSK without the prior written consent of GSK. Moreover, the optimized process will permit to achieve a qualification campaign by July 2003 and to start the ICH stabilities for the NDA.
1. | Precise definition of the industrial manufacturing equipment. |
- | Technical trials |
- | Definition and installation of the technical options on the industrial equipment |
2. | Microcapsules Process scale-up and optimization. (60 - 120 kg/batch) |
- | Layering |
- | Suspension of A.I. optimization |
- | Yield optimization. |
- | Spray-coating |
- | Process parameters |
- | Robustness |
- | Microcapsules characterization. |
3. | Capsule filling |
- | Blending with Mg Stearate and characterizations |
4. | Process validation and manufacturing of 3 Q-batches |
- | Microcapsules process validation on 3 Q-batches (60 — 120 kg / batch) |
- | Blending validation : Mg Stearate |
- | Capsule filling validation |
- | Packaging |
- | Starting ICH stabilities |
5.4 | Analytical Development |
This Section 5.4 will form the basis of the Supply Agreement and will be superceded by the Supply Agreement.
1. | Methods validation |
2. | Accelerated stabilities on development batches |
3. | Testing of development and scale-up batches |
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4. | Full testing on the pilot Q-batches according to the validation protocol |
5. | Testing of the initial industrial scale-up batches. |
6. | Transfer the analytical methodologies to GSK |
6. | CLINICAL BATCHES MANUFACTURING |
The manufacturing of clinical batches not discussed herein will be discussed between the parties and will be the subject of a separate workplan.
7. | QUANTITY OF ACTIVE INGREDIENT NECESSARY |
The quantity of Carvedilol phosphate necessary for this project is estimated to about one hundred (100) kg. Half of that amount will be used for the lab and pilot program and the rest for the initial industrial scale-up work. The quantities necessary for the clinical batches will be estimated according to the specific needs. FLAMEL will also supply Carvedilol free base, depending on the formulation selected. The quantities of the Carvedilol free base will be agreed upon between the parties as appropriate.
8. | PLANNING AND BUDGET |
The development program presented in this document commences January 2003 and ends December 2003.
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SCHEDULE 4.6
Existing Studies and Delivery of Clinical Supplies of Small Particle Micropump
1. | Blending studies of Carvedilol Immediate Release and Carvedilol Controlled Release pellets to support manufacture of phase 11 clinical supplies of Micropump 11 as discussed in the GSK/Flamel meeting in Lyon, France on February 3 and 4, 2003. |
2. | Completion of additional development work and manufacture of clinical supplies to be used in phase I studies on the small size Carvedilol microcapsules as discussed in the GSKJF1amel meeting in Lyon, France on February 3 and 4, 2003. |
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SCHEDULE 4.7
Volumes and Commitments
· | GSK will provide both a three (3) year high level forecast and a fifteen (15) month forecast, the latter being updated at a minimum every six (6) months, with monthly updates to the three (3) months fixed by GSK firm order. These forecasts are not commitments and are for information purposes only; commitments shall be made by GSK firm order. |
2. | Capacity |
· | FLAMEL shall ensure it and its GSK approved suppliers have adequate capacity at all times to fulfill [***] of GSK's firm order(s) within the agreed lead in period. |
3. | Term |
· | [***] with the option for GSK to renew in one year increments unless in case of breach or insolvency |
4. | Notice of Termination and Supply |
· | In the event of termination, FLAMEL or GSK, as the case may be, shall provide at least [***] notice and FLAMEL shall supply all forecasted Product through the end of the notice of termination period; provided, however, and notwithstanding the foregoing, that in the event of termination by FLAMEL, FLAMEL will continue to supply GSK per the terms of the Supply Agreement until technology transfer from FLAMEL to GSK has been completed and GSK have in place a robust supply alternative to FLAMEL. |
5. | Cost of goods |
A. | Clinical Trial Supply |
· | [***] |
B | Launch stock & commercial supply |
· | [***] |
[***]
6. | Continuous Improvement Targets |
· | FLAMEL and GSK shall agree on action plans and continuous improvement targets. [***] |
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7. | Alternative Sources of Materials |
· | In the event that GSK identifies alternative source(s) of supply for constituent elements of the product of equivalent quality from a Third Party on more favorable terms, then FLAMEL shall purchase such materials as GSK shall direct, provided that such materials can be used in accordance with this Agreement. |
· | [***] |
8. | Approvals |
· | The manufacturing facility, GSK approved suppliers, materials, specifications, processes, storage facilities and transport utilized by FLAMEL shall be approved in advance by GSK and shall not be modified without GSK's prior approval. |
· | No capital expenditures will be made by FLAMEL to support the development or manufacture of Product without GSK's prior, written approval. |
· | The manufacturing facility, processes, storage facility and transport will comply with all relevant and applicable standards, including Current Good Manufacturing Practices (cGMPs41), as defined by the US FDA's Code of Federal Regulations (CFR) parts 210, 211, and 820, as applicable, and to permit FDA (or other regulatory agency) inspections of any facilities in which GSK products are produced. |
· | FLAMEL shall ensure excipients and all other materials used in the manufacturing meet the agreed specifications. |
9. | Identity Testing |
· | Following delivery of GSK active and prior to its use in manufacture, FLAMEL shall conduct identity tests and all other tests required to determine compliance with the corresponding specification. |
10. | Supply Chain Optimization |
· | FLAMEL and GSK will work together to identify, develop and implement the optimum robust supply chain for manufacture and supply. |
11. | Inspection |
· | GSK shall have the right to undertake all inspections, tests and batch sampling. |
12. | Yield |
· | GSK and FLAMEL will agree on the specifications for batch yield along with an acceptable range for batches manufactured by FLAMEL. FLAMEL will be liable all costs, including the cost of Carvedilol, for batches that do not meet the yield criteria. |
13. | Batch Failures |
· | GSK shall pay for good in-specification batches only, delivered in accordance with the requirements of the GSK firm order and terms of the Supply Agreement. |
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14. | Contingency Stock Holding |
· | FLAMEL shall maintain a contingency stock holding at levels agreed with GSK, sufficient to ensure continuous supply of product to GSK |
15. | Rejection |
· | GSK shall have the right to reject product that does not comply in quantity or quality with the GSK firm order and the Agreement. |
16. | Title |
· | Title shall transfer to GSK upon receipt and acceptance by GSK. The transfer of title shall not release FLAMEL from any of its rights and responsibilities under this agreement. |
17. | Payment |
· | GSK shall pay FLAMEL within [***] |
18. | Key Performance Indicators |
· | GSK and FLAMEL shall agree performance indicators to measure supply requirements. |
19. | Insurance |
· | GSK and FLAMEL shall agree upon insurance provisions that adequately protect the other party against the risk related to the first party's performance under the Agreement. |
20. | Assignment |
· | FLAMEL shall not at any time assign or sub-contract any of its rights, or obligations whatsoever in this Agreement to any third party |
[***]
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SCHEDULE 6.2
Exceptions To Representations And Warranties
1. | COREG® US AGREEMENT BY AND BETWEEN SMITHKLINE XXXXXXX CORPORATION, SMITHKLINE XXXXXXX PLC AND XXXXXXXX-XX XXXXX LTD., DATED AUGUST 30, 2000 WHEREBY ROCHE HAS GRANTED GSK RIGHTS TO CARVEDILOL IN THE US AND CANADA AND GSK HAS THE OBLIGATION TO OFFER ROCHE A SUBLICENSE TO THE PRODUCT FOR THE ROCHE TERRITORY. |
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SCHEDULE 7.3
Press Release
GlaxoSmithKline and Flamel Technologies
Announce License Agreement
LONDON, England and LYON, France March 28, 2003 GlaxoSmithKline (LSE and NYSE:GSK - news) and Flamel Technologies S.A. (NASDAQ:FLML - news) announced today that they have entered into an agreement whereby Flamel has licensed its controlled-release Micropump® technology to GlaxoSmithKline (`GSK') to develop a new formulation for an undisclosed existing product. Flamel will receive an upfront payment of $2M and additional milestone payments upon achievement of certain events, and royalties on sales of the product. Based on the continued successful development and commercialisation of this formulation, GSK and Flamel estimate that payments to Flamel could range up to $45 million by the end of the first year following launch, of which $25M is attributable to the product reaching certain milestones. Flamel may also participate in the manufacture of product. Additional terms of the agreement have not been disclosed.
Xxxxxx Xxxxx, PhD., president and chief executive officer of Flamel, said "We are very excited about this new development agreement with GSK. We are confident of the potential of Micropump technology for these large, and still growing, markets. This additional agreement further demonstrates the interest of major worldwide pharmaceutical companies in our versatile technology platforms. Moreover, this is our second license agreement with GSK within the past nine months, based on Micropump technology. It confirms the common interest of the two companies to work together. I am very pleased and proud to see GSK, one of the world's premier pharmaceutical companies, expand its relationship with Flamel."
Xxxxxx Xxxxxxxxx, DVM., PhD., FRCPath, Head of the Cardiovascular, Metabolic and Urology Therapeutic Areas, GSK, added, "This collaboration will help us to maintain our leadership in product research and development. We are eager to develop with Flamel leading technologies within our therapeutic areas with the objective of providing the next generation of medicines."
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
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This document contains a number of matters, particularly as related to the status of various research projects and technology platforms, that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The presentation reflects the current view of management with respect to future events and is subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks that products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements, uncertainties regarding market acceptance of products in development, the impact of competitive products and pricing, and the risks associated with Flamel's reliance on outside parties and key strategic alliances. These and other risks are described more fully in Flamel's Annual Report on the Securities and Exchange Commission Form 20-F for the year ended December 31, 2000. Flamel assumes no obligation to update any forward-looking statements.
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SCHEDULE 8.4
Flamel Insurance
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