Common use of CONFIDENTIAL TREATMENT REQUESTED Clause in Contracts

CONFIDENTIAL TREATMENT REQUESTED. necessary to enable Alimera and/or its subcontractors to manufacture and perform quality testing on Medidur FA to satisfy Commercial Supply Requirements, all to the extent set forth in the CDS Development Budget and reimbursed pursuant to Section 3.1.2. CDS and/or its Permitted Subcontractors shall be responsible for the following activities in association therewith (to the extent set forth in the CDS Development Budget and any costs of which will be reimbursed by Alimera in accordance with Section 3.1.2): (a) assist with technology transfer to commercial manufacture site, (b) assist with manufacturing scale-up and validation activities, and (c) transfer analytical methods to commercial manufacture site for stability monitoring. In addition, within ninety (90) days after the Amendment Effective Date, CDS shall provide to Alimera a Pharmaceutical Development Report, the form and content of which should follow the ICH Guidance documents Q8 Pharmaceutical Development (dated May 19, 2006) and draft Q8(R1) Pharmaceutical Development Revision 1 (dated January 10, 2008). Within thirty (30) days after receipt of such report, Alimera shall notify CDS in writing whether such report is accepted or rejected (provided that any rejection must be reasonable). If Alimera notifies CDS of its acceptance or fails to notify CDS of its reasonable rejection within the thirty (30) day time period, then such report is deemed to be accepted. If Alimera reasonably rejects the report, then it shall notify CDS in writing of its reasons, with reasonable specificity, for the rejection, and CDS shall use commercially reasonable efforts to revise the report to address such reasons within ten (10) Business Days following receipt of such rejection notice and reasons. CDS shall submit the revised report to Alimera for another review in accordance with the acceptance procedures and timeline specified above. Alimera shall have primary responsibility, with reasonable input and assistance from CDS, for the preparation of the Chemistry, Manufacturing and Controls (the “CMC”) section of Alimera’s IND and NDA filings. Technology transfer shall be effected in accordance with GMP and ISO guidelines, to the extent applicable for Commercialization in the relevant country.

CONFIDENTIAL TREATMENT REQUESTED. necessary Challenged Patent Rights that would be infringed by the manufacture, use, sale, offer for sale or importation of the Licensed Product by Millennium or any of its Affiliates or Sublicensees in the applicable Challenge Jurisdiction, then (i) the Challenge-Related Royalty Increase shall remain in effect for the remainder of the Royalty Term with respect to enable Alimera and/or Net Sales of Licensed Products in the applicable Challenge Jurisdiction, and (ii) Millennium shall reimburse ImmunoGen for its subcontractors to manufacture out-of-pocket costs and perform quality testing on Medidur FA to satisfy Commercial Supply Requirementsexpenses (including, all without limitation, reasonable attorneys’ and experts’ fees and expenses of litigation) incurred in responding to the extent Challenge. Millennium shall be required to pay such reimbursement within [***] days of receiving an invoice therefor from ImmunoGen, which shall set forth in reasonable detail the CDS Development Budget and reimbursed pursuant basis for the charges for which ImmunoGen is seeking reimbursement. If, following the final, unappealable conclusion of a Challenge in a Challenge Jurisdiction, there remain no Valid Claims within the Challenged Patent Rights that would be infringed by the manufacture, use, sale, offer for sale or importation of Licensed Products by Millennium or any of its Affiliates or Sublicensees in such Challenge Jurisdiction in the absence of the license granted under Section 2.1(a) hereof, then ImmunoGen shall reimburse Millennium for [***] by Millennium to Section 3.1.2. CDS and/or its Permitted Subcontractors ImmunoGen with respect to the Challenge-Related Royalty Increase with respect to the Challenge Jurisdiction (the “Clawback Amount”) as follows: (A) Millennium shall be responsible for entitled to credit [***] of each royalty payment due under Section 5.3 hereof as they become due from and after the following activities final, unappealable conclusion of such Challenge in association therewith such Challenge Jurisdiction against the Clawback Amount [***] until reimbursed in full; and (to B) any unreimbursed portion of the extent set forth Clawback Amount [***] outstanding at the conclusion of the Royalty Term in all countries and jurisdictions in the CDS Development Budget and any costs of which will Territory shall be reimbursed by Alimera in accordance with Section 3.1.2): (a) assist with technology transfer paid to commercial manufacture site, (b) assist with manufacturing scale-up and validation activities, and (c) transfer analytical methods to commercial manufacture site for stability monitoring. In addition, Millennium within ninety (90) days after the Amendment Effective Date, CDS shall provide to Alimera a Pharmaceutical Development Report, the form and content of which should follow the ICH Guidance documents Q8 Pharmaceutical Development (dated May 19, 2006) and draft Q8(R1) Pharmaceutical Development Revision 1 (dated January 10, 2008). Within thirty (30) [***] days after receipt by ImmunoGen of such reportan invoice from Millennium therefor. ImmunoGen may, Alimera shall notify CDS in writing whether such report is accepted or rejected (provided that at any rejection must be reasonable). If Alimera notifies CDS of its acceptance or fails to notify CDS of its reasonable rejection within the thirty (30) day time period, then such report is deemed to be accepted. If Alimera reasonably rejects the report, then it shall notify CDS in writing of its reasons, with reasonable specificity, for the rejectiontime, and CDS shall use commercially reasonable efforts in its sole discretion, pay to revise the report to address such reasons within ten (10) Business Days following receipt Millennium all or any portion of such rejection notice and reasonsClawback Amount [***]. CDS shall submit the revised report to Alimera for another review in accordance with the acceptance procedures and timeline specified above. Alimera shall have primary responsibility, with reasonable input and assistance from CDS, for the preparation of the Chemistry, Manufacturing and Controls (the “CMC”) section of Alimera’s IND and NDA filings. Technology transfer shall be effected in accordance with GMP and ISO guidelines, to the extent applicable for Commercialization in the relevant country[***].

CONFIDENTIAL TREATMENT REQUESTED. humanized antibodies against the MIF antigen. The PARTIES will collaborate initially on the development of a first humanized antibody that shall be funded by the payments made under Article 3 of this CDA. If such first humanized antibody is later determined by the Steering Committee not to be clinically or commercially feasible, and is abandoned, the PARTIES will collaborate on development of a second humanized antibody, the properties of which will be decided and approved by the Steering Committee, based in part on the experience and information obtained from the development of the first humanized antibody. IDEC will not receive additional funding for the development of the second humanized antibody under this CDA. IDEC shall not be required to develop a third humanized antibody, regardless of the feasibility of the second antibody. If the PARTIES agree that development of a first or second humanized antibody requires the licensing of new technology [CONFIDENTIAL TREATMENT REQUESTED], the PARTIES shall share equally the license fees and any cash consideration necessary to enable Alimera and/or its subcontractors secure any such licenses or technology necessary to manufacture and perform quality testing on Medidur FA to satisfy Commercial Supply Requirements, all to the extent make a humanized antibody. 2.02 Except as expressly set forth in this CDA (including its Appendices) and subject to the CDS Development Budget decision of the Steering Committee, IDEC shall have the authority to direct and reimbursed pursuant shall jointly carry out with TAISHO the ANTIBODY RESEARCH and PRODUCT DEVELOPMENT. The general terms regarding the efforts to Section 3.1.2be undertaken in furtherance of ANTIBODY RESEARCH and PRODUCT DEVELOPMENT, including the objectives thereof, have been mutually agreed upon by the PARTIES, and such agreement is incorporated upon the EFFECTIVE DATE within APPENDIX B and APPENDIX C of this CDA and is a part thereof which may be amended from time to time by a mutual agreement of the PARTIES. CDS and/or its Permitted Subcontractors During the term of this CDA, TAISHO may send one (1) researcher to IDEC. TAISHO shall be responsible for such scientist's salary, benefits, living expenses, travel expenses, supply allowance, etc. 2.03 The PARTIES acknowledge that the following activities collaborative effort under this CDA involves subjective business and scientific decisions regarding the progress and direction of the ANTIBODY RESEARCH and PRODUCT DEVELOPMENT, which may require amending APPENDIX B and APPENDIX C from time to time. To facilitate the ANTIBODY RESEARCH and PRODUCT DEVELOPMENT, preceding the EFFECTIVE DATE, the PARTIES have established a committee containing senior research and development members in association therewith equal numbers from both PARTIES (to the extent set forth in the CDS Development Budget and any costs of which will be reimbursed by Alimera in accordance with Section 3.1.2): (a) assist with technology transfer to commercial manufacture site, (b) assist with manufacturing scale-up and validation activities"Steering Committee"), and (c) transfer analytical methods to commercial manufacture site for stability monitoring. In addition, within ninety (90) days after the Amendment Effective Date, CDS shall provide to Alimera a Pharmaceutical Development Report, the form and content of which should follow the ICH Guidance documents Q8 Pharmaceutical Development (dated May 19, 2006) and draft Q8(R1) Pharmaceutical Development Revision 1 (dated January 10, 2008). Within thirty (30) days after receipt of such report, Alimera shall notify CDS in writing whether such report is accepted or rejected (provided that any rejection must be reasonable). If Alimera notifies CDS of its acceptance or fails to notify CDS of its reasonable rejection within the thirty (30) day time period, then such report is deemed to be accepted. If Alimera reasonably rejects the report, then it shall notify CDS in writing of its reasons, with reasonable specificity, for the rejection, and CDS shall use commercially reasonable efforts to revise the report to address such reasons within ten (10) Business Days following receipt of such rejection notice and reasons. CDS shall submit the revised report to Alimera for another review in accordance with the acceptance procedures and timeline specified above. Alimera shall have primary responsibility, with reasonable input and assistance from CDS, for the preparation of the Chemistry, Manufacturing and Controls (the “CMC”) section of Alimera’s IND and NDA filings. Technology transfer shall be effected in accordance with GMP and ISO guidelines, to the extent applicable for Commercialization in the relevant country.Steering Committee shall,

CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. QUALITY AGREEMENT ON DEVELOPMENT, MANUFACTURING, PACKAGING AND TESTING Manufacturing, Packaging and Testing Instructions and Specifications ACCEPTOR and its contractors shall apply the manufacturing, packaging and testing monographs (comprising specifications as well as methods) referenced in Enclosure C. If MAGENTA’s specifications are incorporated into ACCEPTOR’S documentation (or its contractors’), ACCEPTOR will assure that these conversions are accurate, updated as appropriate and that a cross-reference to the appropriate MAGENTA specifications) is referenced in the source document. Inspections and Audits ACCEPTOR agrees that its facilities, operations and quality systems are audited at a minimum annually by MAGENTA in order to ensure compliance with the appropriate level of GMP guidelines and applicable MAGENTA standards. MAGENTA is entitled to perform audits for cause (e.g. undesirable events, launch of products) and/or to send a representative to ACCEPTOR’S or its contractor’s facilities at mutually agreed times during the manufacturing and testing of the PRODUCTS and at reasonable intervals. ACCEPTOR will address audit observations in a timely manner (not greater than [***] days). MAGENTA has the right to stop any operation for MAGENTA if an audit reveals any violation of agreed upon standards and regulations. In case of deviations from standards, regulations or procedures, ACCEPTOR shall open a deviation in its local deviation management system. ACCEPTOR should inform MAGENTA in a timely manner of any perceived or anticipated deviations from standards, regulations or procedures. ACCEPTOR shall allow U.S. federal and local governmental authorities to inspect facilities, operations and quality systems, as it is necessary to enable Alimera and/or its subcontractors facilitate, obtain or maintain the registration in the USA. A representative of MAGENTA may participate only in inspections directly related to manufacture and perform quality testing on Medidur FA to satisfy Commercial Supply Requirements, all MAGENTA activities. ACCEPTOR shall notify MAGENTA of inspections by regulators within [***] hours of ACCEPTOR awareness related to the extent set forth in manufacture of Magenta products by the CDS Development Budget ACCEPTOR. ACCEPTOR must notify MAGENTA about critical or major issues encountered during authority inspections that adversely affect the quality of products manufactured for MAGENTA and reimbursed pursuant to Section 3.1.2. CDS and/or its Permitted Subcontractors shall be responsible for must provide a copy of the following activities in association therewith (to inspection report and the extent set forth in the CDS Development Budget and any costs of which will be reimbursed by Alimera in accordance with Section 3.1.2): (a) assist with technology transfer to commercial manufacture site, (b) assist with manufacturing scale-up and validation activities, and (c) transfer analytical methods to commercial manufacture site for stability monitoringproposed corrective actions within [***] business days. In additioncase MAGENTA is inspected, within ninety (90) days after MAGENTA agrees to inform ACCEPTOR about critical or major issues encountered during authority inspections that adversely affect the Amendment Effective Date, CDS shall provide quality of materials provided by MAGENTA to Alimera a Pharmaceutical Development ReportACCEPTOR. If not otherwise agreed, the form and content audit rights shall survive [***] years upon the termination of which should follow the ICH Guidance documents Q8 Pharmaceutical Development (dated May 19, 2006) and draft Q8(R1) Pharmaceutical Development Revision 1 (dated January 10, 2008). Within thirty (30) days after receipt of such report, Alimera shall notify CDS in writing whether such report is accepted or rejected (provided that any rejection must be reasonable). If Alimera notifies CDS of its acceptance or fails to notify CDS of its reasonable rejection within the thirty (30) day time period, then such report is deemed to be accepted. If Alimera reasonably rejects the report, then it shall notify CDS in writing of its reasons, with reasonable specificity, for the rejection, and CDS shall use commercially reasonable efforts to revise the report to address such reasons within ten (10) Business Days following receipt of such rejection notice and reasons. CDS shall submit the revised report to Alimera for another review in accordance with the acceptance procedures and timeline specified above. Alimera shall have primary responsibility, with reasonable input and assistance from CDS, for the preparation of the Chemistry, Manufacturing and Controls (the “CMC”) section of Alimera’s IND and NDA filings. Technology transfer shall be effected in accordance with GMP and ISO guidelines, to the extent applicable for Commercialization in the relevant countrythis Quality Agreement.

CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. ACCEPTOR and its contractors shall apply the manufacturing, packaging and testing monographs (comprising specifications as well as methods) referenced in Enclosure C. If MAGENTA’s specifications are incorporated into ACCEPTOR’S documentation (or its contractors’), ACCEPTOR will assure that these conversions are accurate, updated as appropriate and that a cross-reference to the appropriate MAGENTA specifications) is referenced in the source document. ACCEPTOR agrees that its facilities, operations and quality systems are audited at a minimum annually by MAGENTA in order to ensure compliance with the appropriate level of GMP guidelines and applicable MAGENTA standards. MAGENTA is entitled to perform audits for cause (e.g. undesirable events, launch of products) and/or to send a representative to ACCEPTOR’S or its contractor’s facilities at mutually agreed times during the manufacturing and testing of the PRODUCTS and at reasonable intervals. ACCEPTOR will address audit observations in a timely manner (not greater than [***] days). MAGENTA has the right to stop any operation for MAGENTA if an audit reveals any violation of agreed upon standards and regulations. In case of deviations from standards, regulations or procedures, ACCEPTOR shall open a deviation in its local deviation management system. ACCEPTOR should inform MAGENTA in a timely manner of any perceived or anticipated deviations from standards, regulations or procedures. ACCEPTOR shall allow U.S. federal and local governmental authorities to inspect facilities, operations and quality systems, as it is necessary to enable Alimera and/or its subcontractors facilitate, obtain or maintain the registration in the USA. A representative of MAGENTA may participate only in inspections directly related to manufacture and perform quality testing on Medidur FA to satisfy Commercial Supply Requirements, all MAGENTA activities. ACCEPTOR shall notify MAGENTA of inspections by regulators within [***] hours of ACCEPTOR awareness related to the extent set forth in manufacture of Magenta products by the CDS Development Budget ACCEPTOR. ACCEPTOR must notify MAGENTA about critical or major issues encountered during authority inspections that adversely affect the quality of products manufactured for MAGENTA and reimbursed pursuant to Section 3.1.2. CDS and/or its Permitted Subcontractors shall be responsible for must provide a copy of the following activities in association therewith (to inspection report and the extent set forth in the CDS Development Budget and any costs of which will be reimbursed by Alimera in accordance with Section 3.1.2): (a) assist with technology transfer to commercial manufacture site, (b) assist with manufacturing scale-up and validation activities, and (c) transfer analytical methods to commercial manufacture site for stability monitoringproposed corrective actions within [***] business days. In additioncase MAGENTA is inspected, within ninety (90) days after MAGENTA agrees to inform ACCEPTOR about critical or major issues encountered during authority inspections that adversely affect the Amendment Effective Date, CDS shall provide quality of materials provided by MAGENTA to Alimera a Pharmaceutical Development ReportACCEPTOR. If not otherwise agreed, the form and content audit rights shall survive [***] years upon the termination of which should follow the ICH Guidance documents Q8 Pharmaceutical Development (dated May 19, 2006) and draft Q8(R1) Pharmaceutical Development Revision 1 (dated January 10, 2008). Within thirty (30) days after receipt of such report, Alimera shall notify CDS in writing whether such report is accepted or rejected (provided that any rejection must be reasonable). If Alimera notifies CDS of its acceptance or fails to notify CDS of its reasonable rejection within the thirty (30) day time period, then such report is deemed to be accepted. If Alimera reasonably rejects the report, then it shall notify CDS in writing of its reasons, with reasonable specificity, for the rejection, and CDS shall use commercially reasonable efforts to revise the report to address such reasons within ten (10) Business Days following receipt of such rejection notice and reasons. CDS shall submit the revised report to Alimera for another review in accordance with the acceptance procedures and timeline specified above. Alimera shall have primary responsibility, with reasonable input and assistance from CDS, for the preparation of the Chemistry, Manufacturing and Controls (the “CMC”) section of Alimera’s IND and NDA filings. Technology transfer shall be effected in accordance with GMP and ISO guidelines, to the extent applicable for Commercialization in the relevant countrythis Quality Agreement.

CONFIDENTIAL TREATMENT REQUESTED. necessary With respect to enable Alimera and/or its subcontractors each Genentech Potential New Product for which IDEC was provided the opportunity to manufacture and perform quality testing on Medidur FA to satisfy Commercial Supply Requirements, all to the extent set forth opt-in the CDS Development Budget and reimbursed pursuant to Section 3.1.22.5(a) before the same shall have [CONFIDENTIAL TREATMENT REQUESTED], and for which IDEC pursuant to Section 2.5(b) timely elected to not opt-in (but not including a failure to elect to opt-in), promptly following [CONFIDENTIAL TREATMENT REQUESTED] for such Genentech Potential New Product, Genentech shall provide IDEC with [CONFIDENTIAL TREATMENT REQUESTED] data package for such Genentech Potential New Product that summarizes the clinical data and the proposed Development Plan going forward, including proposed clinical study designs, timelines and program costs. CDS and/or its Permitted Subcontractors IDEC shall be responsible for have sixty (60) days from the following activities in association therewith (date of Genentech's notice to the extent set forth IDEC of such development assessment package to provide written notice to Genentech that it elects to participate in the CDS Development Budget development and any costs commercialization of which will be reimbursed by Alimera in accordance with Section 3.1.2): (a) assist with technology transfer to commercial manufacture site, (b) assist with manufacturing scale-up and validation activities, and (c) transfer analytical methods to commercial manufacture site for stability monitoring. In addition, within ninety (90) days after the Amendment Effective Date, CDS shall provide to Alimera a Pharmaceutical Development Report, the form and content of which should follow the ICH Guidance documents Q8 Pharmaceutical Development (dated May 19, 2006) and draft Q8(R1) Pharmaceutical Development Revision 1 (dated January 10, 2008)such Genentech Potential New Product. Within thirty (30) days after receipt of such report, Alimera shall notify CDS in writing whether such report is accepted or rejected (provided that any rejection must be reasonable). If Alimera notifies CDS of its acceptance or fails to notify CDS of its reasonable rejection within the thirty (30) day time period, then such report is deemed to be accepted. If Alimera reasonably rejects the report, then it shall notify CDS in writing of its reasons, with reasonable specificity, for the rejection, and CDS shall use commercially reasonable efforts to revise the report to address such reasons within ten (10) Business Days days following receipt an election to participate in such Genentech Potential New Product, IDEC shall pay Genentech the opt-in fee set forth in Section 7.1(b)(iv). From and after the date of the payment of such rejection fee, such Genentech Potential New Product shall be deemed a New Product under this Agreement, and the Parties shall [CONFIDENTIAL TREATMENT REQUESTED] New Product as provided herein. Failure by IDEC under this Section 2.5(c) to provide a timely election notice or to timely pay the opt-in fee will be deemed to be an election not to participate in such Genentech Potential New Product, and reasons. CDS shall submit the revised report to Alimera for another review in accordance with the acceptance procedures and timeline specified above. Alimera following any such failure, Genentech shall have primary responsibility, no further obligation to offer such Genentech Potential New Product to IDEC and IDEC shall have no further rights under this Agreement with reasonable input and assistance from CDS, for the preparation of the Chemistry, Manufacturing and Controls (the “CMC”) section of Alimera’s IND and NDA filings. Technology transfer shall be effected in accordance with GMP and ISO guidelines, respect to the extent applicable for Commercialization in the relevant countrysuch Genentech Potential New Product.

CONFIDENTIAL TREATMENT REQUESTED. necessary Section 3.8 of the PDRA is hereby deleted in its entirety and replaced with the following: “Further Payments. Other than the payments agreed to enable Alimera and/or its subcontractors by the Parties (if any) in any manufacturing agreement contemplated by Section 3.5 or any other agreement contemplated by Section 3.6, Alliance shall have no obligation to manufacture and perform quality testing on Medidur FA to satisfy Commercial Supply Requirementspay Inhale any amounts, all by way of royalties or otherwise, in connection with the development, manufacture, sale, or use of the [CONFIDENTIAL TREATMENT REQUESTED] Designated Products commercialized pursuant to the extent set forth in exercise of Product Development Rights. However, if the CDS Development Budget and reimbursed Parties enter into an agreement pursuant to this Article 3 under which Inhale agrees to perform final container filling or packaging of a Powder Formulation of a Designated Product, or to supply devices to Alliance as provided in Section 3.1.23.6, then such agreement shall provide for additional payments to Inhale as the parties may mutually agree that will provide Inhale reasonable and customary compensation for a license under Inhale’s proprietary technology covering or including such Other Inhale Technology. CDS and/or its Permitted Subcontractors shall be responsible for the following activities in association therewith (In addition to the extent set forth in payments referred to above, Alliance shall pay Inhale a royalty equal to [CONFIDENTIAL TREATMENT REQUESTED] of Net Sales of any Designated Products after the CDS Development Budget and any costs of which will be reimbursed [CONFIDENTIAL TREATMENT REQUESTED] Designated Products sold by Alimera in accordance with Section 3.1.2): Alliance or its Affiliates or Partners. Alliance shall make royalty payments to Inhale (aby wire transfer) assist with technology transfer to commercial manufacture site, (b) assist with manufacturing scale-up and validation activities, and (c) transfer analytical methods to commercial manufacture site for stability monitoring. In addition, within ninety (90) thirty days after the Amendment Effective Dateend of each calendar quarter in which Net Sales occur. Upon the request of Inhale, CDS Alliance shall provide permit Inhale and its representatives, for purposes of auditing the performance of Alliance under this Section 3.8, to Alimera a Pharmaceutical Development Reporthave access (i) during normal business hours to such of the records of Alliance as may be reasonably necessary to verify such performance of Alliance and (ii) to any Partners. If any such audit reveals that any payment required by this Section 3.8 shall have been deficient, Alliance shall immediately pay to Inhale the amount of any such deficiency plus interest from the date otherwise due at the lesser of 18% per annum or the maximum rate permitted under applicable law. If any such deficiency shall be greater than five percent of the amount actually owed, Alliance shall immediately reimburse Inhale for the costs of such audit (including, without limitation, the form and content fees of which should follow the ICH Guidance documents Q8 Pharmaceutical Development (dated May 19, 2006) and draft Q8(R1) Pharmaceutical Development Revision 1 (dated January 10, 2008any accounting firm employed by Inhale for such purpose). Within thirty (30) days after receipt of such report, Alimera shall notify CDS in writing whether such report is accepted or rejected (provided that any rejection must be reasonable). If Alimera notifies CDS of its acceptance or fails to notify CDS of its reasonable rejection within the thirty (30) day time period, then such report is deemed to be accepted. If Alimera reasonably rejects the report, then it shall notify CDS in writing of its reasons, with reasonable specificity, for the rejection, and CDS shall use commercially reasonable efforts to revise the report to address such reasons within ten (10) Business Days following receipt of such rejection notice and reasons. CDS shall submit the revised report to Alimera for another review in accordance with the acceptance procedures and timeline specified above. Alimera shall have primary responsibility, with reasonable input and assistance from CDS, for the preparation of the Chemistry, Manufacturing and Controls (the “CMC.”) section of Alimera’s IND and NDA filings. Technology transfer shall be effected in accordance with GMP and ISO guidelines, to the extent applicable for Commercialization in the relevant country.

CONFIDENTIAL TREATMENT REQUESTED. and reasonably necessary to enable Alimera and/or its subcontractors to manufacture and perform quality testing on Medidur FA to satisfy Commercial Supply Requirements, all to the extent set forth in the CDS Development Budget and reimbursed pursuant to Section 3.1.2. CDS and/or its Permitted Subcontractors shall be responsible for the following activities in association therewith (to the extent set forth in the CDS Development Budget and any costs of which will be reimbursed by Alimera in accordance with Section 3.1.2): (a) assist with technology transfer to commercial manufacture site, (b) assist with manufacturing scale-up and validation activities, and (c) transfer analytical methods to commercial manufacture site for stability monitoring. In addition, within ninety (90) days after the Amendment Effective Date, CDS shall provide to Alimera a Pharmaceutical Development Report, the form and content of which should follow the ICH Guidance documents Q8 Pharmaceutical Development (dated May 19, 2006) and draft Q8(R1) Pharmaceutical Development Revision 1 (dated January 10, 2008). Within thirty (30) days after receipt of such report, Alimera shall notify CDS in writing whether such report is accepted or rejected (provided that any rejection must be reasonable). If Alimera notifies CDS of its acceptance or fails to notify CDS of its reasonable rejection within the thirty (30) day time period, then such report is deemed to be accepted. If Alimera reasonably rejects the report, then it shall notify CDS in writing of its reasons, with reasonable specificity, for the rejection, and CDS shall use commercially reasonable efforts to revise the report to address such reasons within ten (10) Business Days following receipt of such rejection notice and reasons. CDS shall submit the revised report to Alimera for another review in accordance with the acceptance procedures and timeline specified above. Alimera shall have primary responsibility, with reasonable input and assistance from CDS, for the preparation of the Chemistry, Manufacturing and Controls (the “CMC”) section of Alimera’s IND and NDA filings. Technology transfer shall be effected in accordance with GMP and ISO guidelines, to the extent applicable for Commercialization in the relevant country.

CONFIDENTIAL TREATMENT REQUESTED. necessary to enable Alimera and/or its subcontractors to manufacture and perform quality testing on Medidur FA to satisfy Commercial Supply Requirements, all If Tekmira issues the Product Notice prior to the extent set forth acceptance of a bona fide IND filing by a Regulatory Authority in the CDS Development Budget and reimbursed pursuant to Section 3.1.2. CDS and/or its Permitted Subcontractors shall be responsible United States or one of the Major Markets for the following activities applicable Tekmira IOC Product, then Alnylam shall have forty-five (45) days after receipt of such Product Notice (the “Opportunity Response Period”) to notify Tekmira in association therewith writing of its interest in such Tekmira IOC Product. If Alnylam notifies Tekmira in writing within the Opportunity Response Period that it is interested in such Tekmira IOC Product, then the Parties shall promptly commence good faith negotiations (in Tekmira’s case on an exclusive basis) for a period of up to the extent set forth in the CDS Development Budget and any costs of which will be reimbursed by Alimera in accordance with Section 3.1.2): (a) assist with technology transfer to commercial manufacture site, (b) assist with manufacturing scale-up and validation activities, and (c) transfer analytical methods to commercial manufacture site for stability monitoring. In addition, within ninety (90) days after Alnylam receives the Amendment Effective DateProduct Notice in an effort to conclude a mutually acceptable definitive agreement for the exclusive rights to Research, CDS shall provide to Alimera a Pharmaceutical Development Report, the form Develop and content of which should follow the ICH Guidance documents Q8 Pharmaceutical Development Commercialize such Tekmira IOC Product (dated May 19, 2006) and draft Q8(R1) Pharmaceutical Development Revision 1 (dated January 10, 2008“Product License”). Within thirty The royalties payable to Tekmira in respect of such Tekmira IOC Product contained in such definitive agreement will be equal to the royalties and milestones payable with respect to an IOC Product under this Agreement; provided, however that Tekmira shall not be required to reimburse Alnylam for any royalties or milestones payable by Alnylam in respect of such Tekmira IOC Product under any Third Party agreements pursuant to which Alnylam Controls the Alnylam IOC Technology licensed to Tekmira under this Agreement that Cover such Tekmira IOC Product, and the agreement will otherwise contain reasonable and customary terms that are consistent with the terms of this Section 6.9(b); provided, however, that the Parties shall enter into good faith negotiations to agree upon ancillary financial provisions to compensate Tekmira for its prior reasonable Research and Development expenditures solely in connection with such Tekmira IOC Product, which expenditures shall be based on the properly allocated costs and expenses directly incurred by Tekmira for the Research, Development and/or Manufacture of such Tekmira IOC Product through and including the Opportunity Response Period, which costs shall include all reasonable and properly allocated internal costs (30determined in accordance with the then-current Tekmira FTE Rate) for the FTEs directly performing Research, Development and Manufacturing activities with respect to such Tekmira IOC Product during such period and the reasonable, direct out-of-pocket expenses actually paid by Tekmira in its performance of the Research, Development and/or Manufacture of such Tekmira IOC Product. If Tekmira issues the Product Notice after the acceptance of a bona fide IND filing by a Regulatory Authority in the United States or one of the Major Markets for the applicable Tekmira IOC Product, then Alnylam shall have ninety (90) days after receipt of such report, Alimera shall notify CDS in writing whether such report is accepted or rejected Product Notice (provided that any rejection must be reasonable). If Alimera notifies CDS of its acceptance or fails the “Post-IND Opportunity Response Period”) to notify CDS of its reasonable rejection within the thirty (30) day time period, then such report is deemed to be accepted. If Alimera reasonably rejects the report, then it shall notify CDS Tekmira in writing of its reasonsinterest in such Tekmira IOC Product. If Alnylam notifies Tekmira in writing within the Post-IND Opportunity Response Period that it is interested in such Tekmira IOC Product, with reasonable specificity, then the Parties will use Commercially Reasonable Efforts to negotiate and execute a definitive agreement for the rejection, Product reasonable and CDS shall use commercially reasonable efforts to revise the report to address such reasons within ten (10) Business Days following receipt of such rejection notice and reasons. CDS shall submit the revised report to Alimera for another review in accordance with the acceptance procedures and timeline specified above. Alimera shall have primary responsibility, with reasonable input and assistance from CDS, for the preparation of the Chemistry, Manufacturing and Controls (the “CMC”) section of Alimera’s IND and NDA filings. Technology transfer shall be effected in accordance with GMP and ISO guidelines, customary terms mutually agreeable to the extent applicable Parties, including appropriate financial consideration after taking into account the maturity of Tekmira’s Research, Development and Commercialization activities through and including the Opportunity Response Period. If (x) Alnylam notifies Tekmira that it is not interested in obtaining a Product License with respect to such Tekmira IOC Product, (y) Alnylam does not notify Tekmira in writing within the Opportunity Response Period that it is interested in such Tekmira IOC Product, or (z) despite each Party’s good faith efforts, Alnylam and Tekmira are not able to reach agreement on and execute a definitive agreement for Commercialization in the relevant countrya Product License within such one hundred and twenty (120) day period, then Tekmira may enter into negotiations with any Third Party for such Tekmira IOC Product.

CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. QUALITY AGREEMENT ON DEVELOPMENT, MANUFACTURING, PACKAGING AND TESTING ACCEPTOR or MAGENTA, as applicable, shall prepare a change request in writing upon identification of a necessary change as indicated above. In such change request, the following items, at a minimum, shall be defined: a comparative description of the change (current versus intended status) the rational for the change a GMP assessment regulatory assessment medical/safety assessment (if applicable) MAGENTA will decide, at its sole discretion, to enable Alimera and/or approve or reject the change request following an inter-functional evaluation. MAGENTA will inform ACCEPTOR of its subcontractors decision within [***] days after having received the change request or notification of a necessary change. Influence on Quality by Foreign Materials MAGENTA must be informed in advance and upon request in writing, of each critical compound or processing of critical compounds in the same area as any PRODUCT. The term “critical” as used in this Section 2.10 shall mean [***]. If a starting/raw material is of animal origin, the ACCEPTOR shall attempt to manufacture and perform quality testing obtain from the vendor a statement regarding the country of origin of the animal material or TSE Certificate according to Note for Guidance EMEA/410/01, Rev. 2 or applicable update. If a CoA on Medidur FA starting material is provided to satisfy Commercial Supply RequirementsMAGENTA, it shall clearly state the origin of the material. MAGENTA reserves the right to request copies of any or all questionnaires related to the extent set forth in starting materials used for their PRODUCT. The use of animal or human derived raw material requires prior written approval by MAGENTA. For material of bovine or ruminant origin, a TSE Certificate of Suitability (CoS) from the CDS Development Budget and reimbursed pursuant to Section 3.1.2. CDS and/or its Permitted Subcontractors shall be responsible European Directorate for the following activities Quality of Medicines (EDQM) is required. In case such information could not be provided for a material, ACCEPTOR, with the support of MAGENTA if necessary, should be able to document that FDA has agreed with the use of the material for human use. For starting/raw materials, excipients, cleaning agents, softeners or lubricants, or primary packaging materials procured by MAGENTA, it is MAGENTA’s responsibility that materials supplied to ACCEPTOR are in association therewith compliance with the TSE Guideline (to Note for Guidance on minimizing the extent set forth in the CDS Development Budget risk of transmitting spongiform encephalopathy agents via human and any costs of which veterinary medicinal products (EMEA/410/01, Rev. 2 or applicable update) and/or acceptable by FDA for clinical GMP use. The traceability and safety documentation will be reimbursed by Alimera in accordance provided to MAGENTA upon request. ACCEPTOR shall ensure that cord blood is supplied from cord blood banks that are registered with Section 3.1.2): (a) assist with technology transfer to commercial manufacture site, (b) assist with manufacturing scale-up and validation activities, and (c) transfer analytical methods to commercial manufacture site for stability monitoringthe FDA. ACCEPTOR shall ensure cord blood is supplied from MCT approved vendors when possible. In addition, within ninety (90) days after the Amendment Effective Date, CDS shall provide to Alimera a Pharmaceutical Development Reportcases where an acceptable cord blood cannot be identified from an approved vendor, the form and content of which should follow the ICH Guidance documents Q8 Pharmaceutical Development (dated May 19, 2006) and draft Q8(R1) Pharmaceutical Development Revision 1 (dated January 10, 2008). Within thirty (30) days after receipt of such report, Alimera shall notify CDS in writing whether such report is accepted or rejected (provided cord blood may be obtained from a vendor that any rejection must be reasonable). If Alimera notifies CDS of its acceptance or fails to notify CDS of its reasonable rejection within the thirty (30) day time period, then such report is deemed to be accepted. If Alimera reasonably rejects the report, then it shall notify CDS in writing of its reasons, with reasonable specificity, for the rejection, and CDS shall use commercially reasonable efforts to revise the report to address such reasons within ten (10) Business Days following receipt of such rejection notice and reasons. CDS shall submit the revised report to Alimera for another review in accordance with the acceptance procedures and timeline specified above. Alimera shall have primary responsibility, with reasonable input and assistance from CDS, for the preparation of the Chemistry, Manufacturing and Controls (the “CMC”) section of Alimera’s IND and NDA filings. Technology transfer shall be effected in accordance with GMP and ISO guidelines, to the extent applicable for Commercialization in the relevant countryhas not been approved by MCT.

CONFIDENTIAL TREATMENT REQUESTED. necessary CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION Sublicensee) with such quantities of Clinical Materials as may be reasonably requested by GENENTECH (or its Material Sublicensee) in order to enable Alimera and/or conduct all human clinical trials of Licensed Products through Phase II Clinical Studies. GENENTECH (or its subcontractors to manufacture Material Sublicensee) shall order all amounts of Clinical Materials, and perform quality testing on Medidur FA to satisfy Commercial Supply RequirementsIMMUNOGEN shall deliver all such ordered amounts, all to the extent set forth in the CDS Development Budget and reimbursed pursuant to Section 3.1.2. CDS and/or its Permitted Subcontractors shall be responsible for the following activities in association therewith (to the extent set forth in the CDS Development Budget and any costs of which will be reimbursed by Alimera in accordance with Section 3.1.2): (a) assist with technology transfer to commercial manufacture siteforecasting parameters, (b) assist with manufacturing scale-up advance ordering timeframes and validation activities, and (c) transfer analytical methods to commercial manufacture site for stability monitoring. In addition, within ninety (90) days after the Amendment Effective Date, CDS shall provide to Alimera a Pharmaceutical Development Report, the form and content of which should follow the ICH Guidance documents Q8 Pharmaceutical Development (dated May 19, 2006) and draft Q8(R1) Pharmaceutical Development Revision 1 (dated January 10, 2008). Within thirty (30) days after receipt of such report, Alimera shall notify CDS in writing whether such report is accepted or rejected (provided that any rejection must be reasonable). If Alimera notifies CDS of its acceptance or fails to notify CDS of its reasonable rejection within the thirty (30) day time period, then such report is deemed delivery timeframes to be acceptedagreed upon by the Parties through the JPDC. If Alimera reasonably rejects the report, then it shall notify CDS in writing of its reasons, with reasonable specificity, for the rejection, and CDS IMMUNOGEN shall use its commercially reasonable efforts to revise the report to address deliver such reasons within ten (10) Business Days following receipt amounts of such rejection notice and reasons. CDS shall submit the revised report to Alimera for another review Clinical Materials ordered in accordance with the acceptance procedures and timeline specified aboveforegoing (including such agreed upon timeframes) in a timely manner. Alimera In connection with any ordering of Clinical Materials by GENENTECH (or its Material Sublicensee), IMMUNOGEN shall have primary responsibility, provide GENENTECH (or its Material Sublicensee) promptly with reasonable input and assistance from CDS, for the preparation IMMUNOGEN's good faith estimate of the ChemistryFully Burdened Manufacturing Cost for manufacture and supply of such Clinical Materials. IMMUNOGEN's price to supply Clinical Materials to GENENTECH (or its Material Sublicensee) shall equal [*] of IMMUNOGEN'S Fully Burdened Manufacturing Cost for such Clinical Materials as approved by GENENTECH (or its Material Sublicensee). Nothing herein shall preclude GENENTECH from making its own arrangements for manufacture and supply of Clinical Materials on its own or with Third Parties, Manufacturing in exercise of its license rights under Section 2.1. GENENTECH hereby agrees that (a) it shall use the Clinical Materials in compliance with all applicable federal, state and Controls local laws, and (b) it (as a matter of contract between itself and IMMUNOGEN) shall assume all liability for damages that may arise from the “CMC”) section use, storage and disposal of Alimera’s IND and NDA filings. Technology transfer shall be effected in accordance with GMP and ISO guidelines, such Clinical Materials to the extent applicable for Commercialization provided pursuant to Section 9 below. GENENTECH shall be entitled to transfer Clinical Materials to any Third Party under terms obligating such Third Party not to transfer or use such Clinical Materials except in compliance with the relevant countryforegoing clause (a) of this Section 3.6.

CONFIDENTIAL TREATMENT REQUESTED. necessary to enable Alimera and/or its subcontractors to (b) The manufacture and perform quality testing supply by Genethon of batches of Product for commercial purposes shall be the subject of further discussions in good faith between the Parties and shall in any case depend on Medidur FA Genethon demonstrating its capability to satisfy Commercial Supply Requirementsconduct such manufacturing, all it being understood that in no event shall either Party be liable to the extent other in case of failure to agree on the terms of such manufacturing. In the event the Parties are unable to agree on such terms, at Audentes’s request, Genethon shall promptly perform the activities set forth in Section 2.4(d). (c) At any time during the CDS Development Budget and reimbursed pursuant Term, should Genethon be unable to Section 3.1.2. CDS and/or its Permitted Subcontractors shall be responsible manufacture Product required by Audentes for the following activities performance of clinical development in association therewith (a timely manner consistent with the agreed timelines, the JDC shall meet promptly to discuss the extent set forth in situation and possible actions to remedy the CDS Development Budget situation, including if appropriate the related work plan timelines and any costs budget. Should the JDC be unable to agree on remedial actions for a period of which [*] after their first meeting, the matter will be reimbursed by Alimera submitted to, the Parties’ respective CEOs for resolution. Should the CEOs be unable to agree on remedial actions to implement for a period of [*] after the matter has been submitted to them, then, if the transfer of such manufacturing to Audentes or a Third Party subcontractor or CMG would [*] as compared with [*] or would [*], Genethon will [*] in accordance with Section 3.1.2): 2.4(d) below, subject to the principles set out in Sections 2.4(e) and 5.3 below. (ad) assist with In any case of technology transfer to commercial manufacture siteunder Sections 2.4(b) and/or 2.4(c), (b) assist with manufacturing scale-up and validation activities, and (c) transfer analytical methods to commercial manufacture site for stability monitoring. In addition, within ninety (90) days after the Amendment Effective Date, CDS Genethon shall provide to Alimera Audentes or its designee, such assistance and materials, including but, not limited to drawings, procedures and other documents and materials (including any relevant item of Background Know-How and/or Program Know-How) as Audentes may request, to enable Audentes or its designee (including a Pharmaceutical Development Reportmanufacturer) to manufacture the Products and, if requested by Audentes, Genethon shall reasonably assist Audentes in locating other Third Parties to continue the form manufacture of the Products. (e) In any case of technology transfer under Sections 2.4(b) and/or 2.4(c), Audentes shall provide to Genethon in advance the identity and content address of which should follow any proposed Third Party manufacturer. The transfer shall also be subject to the ICH Guidance documents Q8 Pharmaceutical Development Third Party manufacturer entering into a customary agreement to protect the confidentiality of Background Intellectual Property and Program Intellectual Property provided by Genethon and undertaking to use such Intellectual Property only for the purpose of manufacturing Product for the benefit of Audentes, its Affiliates and/or licensees or sublicensees. Genethon may object to the proposed Third Party manufacturer but only on the basis of reasonable concerns (dated May 19, 2006based on documentation reasonably acceptable to Audentes) and draft Q8(R1) Pharmaceutical Development Revision 1 (dated January 10, 2008). Within thirty (30) days after receipt as to the security of any confidential Know-How of Genethon to be provided to the Third Party manufacturer as part of such report, Alimera shall notify CDS in writing whether such report is accepted or rejected (provided that any rejection must be reasonable). If Alimera notifies CDS of its acceptance or fails to notify CDS of its reasonable rejection within the thirty (30) day time period, then such report is deemed to be accepted. If Alimera reasonably rejects the report, then it shall notify CDS in writing of its reasons, with reasonable specificity, for the rejection, and CDS shall use commercially reasonable efforts to revise the report to address such reasons within ten (10) Business Days following receipt of such rejection notice and reasons. CDS shall submit the revised report to Alimera for another review in accordance with the acceptance procedures and timeline specified above. Alimera shall have primary responsibility, with reasonable input and assistance from CDS, for the preparation of the Chemistry, Manufacturing and Controls (the “CMC”) section of Alimera’s IND and NDA filings. Technology transfer shall be effected in accordance with GMP and ISO guidelines, to the extent applicable for Commercialization in the relevant countrytechnology transfer.

CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Any use of materials or PRODUCT not meeting the specifications after testing is not allowed unless authorized in writing by MAGENTA. Reprocessing in the sense of repeating process steps that are part of the established manufacturing procedure are only allowed in exceptional cases and require prior written approval from MAGENTA unless otherwise necessary to enable Alimera and/or its subcontractors ensure patient safety. Rework of PRODUCTS in the sense of performing process steps that are different from the agreed manufacturing process is not allowed unless otherwise necessary to manufacture ensure patient safety and perform quality require prior written approval from MAGENTA QA, ACCEPTOR Medical Director, Principal Investigator, and ACCEPTOR QA who must approve changes prior to product release. After detailed review of the batch documentation of each batch by ACCEPTOR (including manufacturing and testing on Medidur FA records), ACCEPTOR QA is responsible to satisfy Commercial Supply Requirements, all ensure that a statement of compliance with FDA requirements is included or attached to the extent set forth in the CDS Development Budget and reimbursed pursuant to Section 3.1.2certificate of analysis (CoA) that is signed by a qualified person. CDS and/or its Permitted Subcontractors shall be responsible A suitable format of this statement or document as well as a check list for the following activities in association therewith (to the extent set forth in the CDS Development Budget and any costs of which detailed review will be reimbursed by Alimera mutually agreed upon. Unless otherwise delegated, MAGENTA will conduct a full batch record review in accordance with Section 3.1.2): (a) assist with technology transfer addition to commercial manufacture site, (b) assist with manufacturing scale-up and validation activities, and (c) transfer analytical methods ACCEPTOR. ACCEPTOR will systematically provide to commercial manufacture site MAGENTA the batch documentation for stability monitoring. In addition, within ninety (90) each lot of PRODUCT no later than [***] days after the Amendment Effective Date, CDS shall provide final sign-off by ACCEPTOR QA. MAGENTA QA will perform final regulatory/quality product release. If necessary MAGENTA may request additional documents related to Alimera a Pharmaceutical Development Report, the form and content of which should follow the ICH Guidance documents Q8 Pharmaceutical Development batch records (dated May 19, 2006) and draft Q8(R1) Pharmaceutical Development Revision 1 (dated January 10, 2008example: CoA from raw materials). Within thirty (30) days after receipt ACCEPTOR is responsible to ensure that products are stored under appropriate conditions of such reporttemperature and humidity, Alimera light and cleanliness so that identity, strength and purity of the PRODUCTS are not affected even during interim storage or shipment. In the event that the quality of the stored PRODUCTS could be adversely affected for any reason, ACCEPTOR shall notify CDS take immediate action to prevent further damage. In any case ACCEPTOR shall inform MAGENTA in writing whether such report is accepted or rejected (provided that any rejection must be reasonable)within [***] days. If Alimera notifies CDS of its acceptance or fails to notify CDS of its reasonable rejection within The requirements regarding the thirty (30) day time period, then such report is deemed to be accepted. If Alimera reasonably rejects the report, then it shall notify CDS in writing of its reasons, with reasonable specificity, for the rejection, and CDS shall use commercially reasonable efforts to revise the report to address such reasons within ten (10) Business Days following receipt of such rejection notice and reasons. CDS shall submit the revised report to Alimera for another review in accordance with the acceptance procedures and timeline specified above. Alimera shall have primary responsibility, with reasonable input and assistance from CDS, for the preparation storage of the Chemistry, Manufacturing and Controls (the “CMC”) section of Alimera’s IND and NDA filings. Technology transfer shall be effected PRODUCTS are defined in accordance with GMP and ISO guidelines, to the extent applicable for Commercialization in the relevant country.Enclosure B.