Common use of Product Development Clause in Contracts

Product Development. (a) Supplier may develop enhancements it intends to incorporate into the BioGlue Surgical Adhesive during the term of this Agreement that have potential application to the Company Product (“Enhancements”). Unless otherwise agreed by the parties, at least once every six months during the Term, representatives of each of BioForm and Supplier shall hold a meeting in accordance with Sections 4.4 and 8.4 (the “Product Development Meeting”) at which Supplier will present Enhancements for BioForm to consider for application to the Company Product. At such Product Development Meeting, BioForm will also present its marketing plans (pursuant to Section 4.4) for the period and any information or feedback that BioForm reasonably believes may lead to Improvements. Within 30 calendar days following each Product Development Meeting, Supplier shall deliver a notice to BioForm (the “Enhancements Notice”) that shall describe the Enhancements that were presented by Supplier at such Product Development Meeting. Within 30 calendar days following receipt of the Enhancements Notice, BioForm may notify Supplier in writing if BioForm elects that any Enhancement described in the Enhancements Notice shall become an Improvement. If BioForm does provide such notice to Supplier during such 30-calendar day period, then BioForm and Supplier shall agree on a timeline for implementation of the Improvement in new Product Specifications for Company Product. If BioForm does not provide such a notice, said Enhancement shall not be implemented into the Company Product. The Enhancements Notice may also describe any potential Enhancements presented by Supplier at the Product Development Meeting, but BioForm shall not be required to take any action under this Section 8.4 with respect to such potential Enhancements until such time as they are presented by Supplier as Enhancements at a future Product Development Meeting. All Enhancements and potential Enhancement information provided by Supplier shall be considered Supplier Confidential Information. (b) From time to time, each party may request the other party to participate in joint projects to develop Improvements. Neither party is obligated to participate in such projects, and in each **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. instance, each party’s decision whether to participate will be made in such party’s sole discretion. If both parties mutually agree to participate in such a project (a “Program”), the parties will promptly prepare a mutually agreeable written development agreement specifying the development activities to be performed by and the research and development tasks assigned to each party (the “Development Agreement”). All allocation of Intellectual Property rights with respect to any Program will be set forth in writing in the Development Agreement. (c) In the absence of a Development Agreement, (i) BioForm and Supplier shall retain joint ownership of Intellectual Property rights in which there is joint inventorship by BioForm (or its Affiliates) and Supplier, as determined in accordance with United States patent law, with Supplier’s rights in such joint ownership being subject to the license rights of BioForm under this Agreement, (ii) any Intellectual Property rights related to the Company Products, Enhancements, and Improvements that are created solely by employees or consultants of Supplier during the Term shall be considered to be Intellectual Property rights of Supplier, subject to the license rights of BioForm under this Agreement, and (iii) any Intellectual Property rights related to the Company Products and Improvements that are created solely by employees or consultants of BioForm or any of its Affiliates during the Term shall be considered to be Intellectual Property rights of BioForm. BioForm hereby grants to Supplier a perpetual, royalty free, world-wide, nonexclusive license to Supplier under such Blocking Intellectual Property to make, use, and sell such Intellectual Property outside the Field. “Blocking Intellectual Property” for the purposes of Section 8.4(c)(iii) shall mean Intellectual Property necessary for Supplier to make, use, or sell SA Product.

Product Development. 4.1 The PMT shall be responsible for managing R&D Work, Preclinical Work, Clinical Work, Production Work and Regulatory Work as well as related activities performed under the provisions of this Agreement. The chairperson of the PMT shall be chosen by HMRI. Beginning within sixty (a60) Supplier may develop enhancements it intends to incorporate into days after the BioGlue Surgical Adhesive during Effective Date of this Agreement and continuing through the term of this Agreement that have potential application to Agreement, the Company Product (“Enhancements”). Unless PMT will, unless otherwise agreed by the parties: a) assume responsibility for the Plans as established in Section 4.3; b) establish, update yearly and seek approval from the Steering Committee for the Plans so long as appropriate which will specify a reasonable level of detail by which ALLIANCE and HMRI will conduct R&D Work, Preclinical Work, Clinical Work, Production Work and Regulatory Work; c) meet and review progress of R&D Work, Preclinical Work, Clinical Work, Production Work and Regulatory Work at least once quarterly unless ALLIANCE and HMRI otherwise agree, and direct changes or modifications to the Plans as well as budgets therefor; d) establish a budget for each of the Plans and determine projected additional costs or savings associated with any changes or modifications thereto; e) present a report with a reasonable level of detail at least every six (6) months during the Term, representatives of each of BioForm and Supplier shall hold a meeting in accordance with Sections 4.4 and 8.4 (the “Product Development Meeting”) at which Supplier will present Enhancements for BioForm to consider for application to the Company Product. At such Product Development MeetingSteering Committee on all activities of the PMT, BioForm will also present its marketing plans (pursuant to Section 4.4) including a budget update, progress by the parties under the current Plans and progress by the PMT on developing Plans for the period next year and associated budgets; f) approve any information material agreements with any Third Party to be made by either or feedback that BioForm reasonably believes may lead to Improvements. Within 30 calendar days following each Product Development Meeting, Supplier shall deliver a notice to BioForm (the “Enhancements Notice”) that shall describe the Enhancements that were presented by Supplier at such Product Development Meeting. Within 30 calendar days following receipt of the Enhancements Notice, BioForm may notify Supplier in writing if BioForm elects that any Enhancement described in the Enhancements Notice shall become an Improvement. If BioForm does provide such notice to Supplier during such 30-calendar day period, then BioForm and Supplier shall agree on a timeline for implementation of the Improvement in new Product Specifications for Company Product. If BioForm does not provide such a notice, said Enhancement shall not be implemented into the Company Product. The Enhancements Notice may also describe any potential Enhancements presented by Supplier at the Product Development Meeting, but BioForm shall not be required to take any action under this Section 8.4 with respect to such potential Enhancements until such time as they are presented by Supplier as Enhancements at a future Product Development Meeting. All Enhancements and potential Enhancement information provided by Supplier shall be considered Supplier Confidential Information. (b) From time to time, each party may request the other party to participate in joint projects to develop Improvements. Neither party is obligated to participate in such projects, and in each **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect both parties hereto related to the omitted portions. instance, each party’s decision whether to participate will be made in such party’s sole discretion. If both parties mutually agree to participate in such a project (a “Program”), the parties will promptly prepare a mutually agreeable written development agreement specifying the development activities to be performed by and the research and development tasks assigned to each party (the “Development Agreement”). All allocation performance of Intellectual Property rights with respect to any Program will be set forth in writing in the Development Agreement. (c) In the absence of a Development Agreement, (i) BioForm and Supplier shall retain joint ownership of Intellectual Property rights in which there is joint inventorship by BioForm (or its Affiliates) and Supplier, as determined in accordance with United States patent law, with Supplier’s rights in such joint ownership being subject to the license rights of BioForm their obligations under this Agreement, except where the selection of such a Third Party is the unilateral right of either party hereunder; and g) determine when the regulatory submissions for the United States and Canada are to be transferred to HMRI from ALLIANCE. 4.2 Actions taken by the PMT pursuant to this Agreement as specified in Section 4.1 shall be taken only following unanimous agreement of the parties (iiHMRI and ALLIANCE each having one (1) vote) or at the direction of the Steering Committee. 4.3 Subject to the provisions of this Agreement and approval by the Steering Committee, ALLIANCE agrees to use its reasonable best efforts to execute and complete the Plans as assigned, described and budgeted as set forth in Appendix B and any Intellectual Property rights future Plans authorized pursuant to this Agreement. Subject to the provisions of this Agreement, HMRI agrees to use its reasonable best efforts to execute and complete the Plans as assigned, described and budgeted as set forth in Appendix C and any future Plans authorized pursuant to this Agreement. The PMT and the Steering Committee will exercise the same oversight and control of the Plans of Appendix B and Appendix C as if these Plans had been approved by the Steering Committee hereunder, and said oversight and control will specifically include directing changes and modifications to the Plans. Subject to Section 13.1, HMRI agrees to provide funding to ALLIANCE through June 30, 1997 of at least the amount set forth on Appendix B to develop the Products in the United States and Canada and to make the estimated quarterly payments to ALLIANCE set forth therein, which amounts will be solely applied to Plan Costs and are not refundable. ALLIANCE agrees to utilize the funds for the development of Products in the United States and Canada, and, in the event notice of termination of this Agreement is not given prior to June 30, 1997, any amount of such quarterly payments not previously applied to Plan Costs shall be applied to ALLIANCE's worldwide Plan Costs incurred after June 30, 1997. The parties agree that the Plans may change from time to time but the HMRI financial commitment reflected in Appendix B shall not decrease. If there are any proposed changes of whatever nature to Appendix B (other than the level of financial commitment), and the PMT, or the Steering Committee fail to reach unanimous agreement on said changes in accordance with the procedures set forth herein, then HMRI will have the final decision with respect to said changes. Either party may deliver to the PMT a list of proposed R&D Work, Preclinical Work, Clinical Work, Production Work and Regulatory Work Plans for the following calendar years, a description of each project and an estimated budget for each project. The proposed project description shall include a detailed plan, an itemized estimate of costs and time required, the name of the project leader, where the project will be carried out and the expected benefit. The PMT will review the list of proposed Plans, revise the proposed projects as it sees fit, and devise a R&D Work Plan, Preclinical Work Plan, Clinical Work Plan, Production Work Plan and Regulatory Work Plan from the proposed projects or from projects proposed by the PMT itself. The PMT will establish a budget for each of the Plans. Such Plans and budgets therefor shall be submitted by the PMT to the Steering Committee for approval. 4.4 HMRI shall pay all Plan Costs, and shall reimburse ALLIANCE for all of its Plan Costs incurred after March 31, 1996. Plan Costs include all out-of- pocket, direct, and indirect expenses ordinary and necessary to the execution of an approved Plan. Out-of-pocket costs, which include payments to third parties for supplies, materials, clinical travel, contracted outside services, etc., shall be documented by records reasonably acceptable to HMRI. Direct and indirect expenses of research and/or development personnel (including, without limitation, scientists, lab technicians, regulatory personnel, clinical support personnel, and the like) shall be expressed in terms of the full-time equivalent ("FTE") rate then in effect for ALLIANCE during the relevant time period. The FTE rate shall be calculated by determining the payroll cost for ALLIANCE's scientific and technical personnel who allocate time among various projects in ALLIANCE's ordinary course of business (including costs for fringe benefits and payroll taxes) and an overhead rate, which includes all costs other than out-of-pocket expenses for ALLIANCE's projects, including LIQUIVENT-Registered Trademark-. During the term of this Agreement, ALLIANCE shall use its standard project costing and accounting system then in effect in computing and tracking its direct and indirect costs. The objective of reimbursing costs in the manner set forth herein is to reimburse Alliance for its actual expenses in carrying out the Plan. b) By October 1 of each year, the PMT will establish an overall project budget for the upcoming calendar year broken down by major work areas/teams and establish FTE labor and overhead rates to be used as benchmarks to measure performance and accountability. At 6-month intervals, the PMT will add an additional 6-month budget, thus maintaining a rolling 12-month budget. 4.5 Any sums due to ALLIANCE by HMRI pursuant to Articles 4, 8 or 9 shall be billed by ALLIANCE each calendar quarter, substantiated by ALLIANCE with suitable invoices and other reasonable documentation, including documentation based on the actual FTE spending rates for labor and overhead, and paid by HMRI within forty-five (45) days of receipt of such invoices. 4.6 The parties agree to promptly provide each other with copies of records, reports, and regulatory filings showing a reasonable level of detail related to their respective work in the Company ProductsUnited States, EnhancementsJapan, and Improvements that are created solely by employees or consultants each Major European Country conducted under the terms of Supplier during the Term shall be considered to be Intellectual Property rights of Supplierthis Agreement, subject to the license rights of BioForm under this Agreement, and (iii) any Intellectual Property rights related to the Company Products and Improvements that are created solely by employees or consultants of BioForm or any of its Affiliates during the Term shall be considered to be Intellectual Property rights of BioForm. BioForm hereby grants to Supplier a perpetual, royalty free, world-wide, nonexclusive license to Supplier under such Blocking Intellectual Property to make, use, and sell such Intellectual Property outside the Field. “Blocking Intellectual Property” for the purposes of confidentiality obligations described in Section 8.4(c)(iii) shall mean Intellectual Property necessary for Supplier to make, use, or sell SA Product3.5.

Product Development. 2.1.1 As between Akcea and PTC, in the Akcea Territory, Akcea is solely responsible for the Development activities relating to the Products and AKCEA-TTR-LRx in accordance with the terms of the Ionis Pharmaceuticals/Akcea License Agreements, the Strategic Plans and Transition Plans (each as defined therein) and any Regulatory (as defined therein) strategies contemplated under the Ionis Pharmaceuticals/Akcea License Agreements. As between Akcea and PTC, all costs and expenses incurred by or on behalf of Akcea in the performance of such Development activities shall be borne solely by Akcea. 2.1.2 Akcea shall promptly notify PTC (but in any case within [***]) of any Material Changes (as defined in the Ionis Pharmaceuticals/Akcea License Agreements) to the Strategic Plans and any material changes to the Transition Plans that have been approved pursuant to the Ionis Pharmaceuticals/Akcea License Agreements that may affect the Development of the Products in the PTC Territory. 2.1.3 Akcea shall consult with PTC in good faith regarding (a) Supplier may develop enhancements it intends to incorporate into the BioGlue Surgical Adhesive during conduct and implementation of Akcea’s activities under the term of this Agreement that have potential application Strategic Plans and the Transition Plans relating to the Company Product (“Enhancements”). Unless otherwise agreed by the parties, at least once every six months during the Term, representatives of each of BioForm and Supplier shall hold a meeting in accordance with Sections 4.4 and 8.4 (the “Product Development Meeting”) at which Supplier will present Enhancements for BioForm to consider for application to the Company Product. At such Product Development Meeting, BioForm will also present its marketing plans (pursuant to Section 4.4) for the period and any information or feedback that BioForm reasonably believes may lead to Improvements. Within 30 calendar days following each Product Development Meeting, Supplier shall deliver a notice to BioForm (the “Enhancements Notice”) that shall describe the Enhancements that were presented by Supplier at such Product Development Meeting. Within 30 calendar days following receipt of the Enhancements Notice, BioForm may notify Supplier in writing if BioForm elects that any Enhancement described Products in the Enhancements Notice shall become an Improvement. If BioForm does provide such notice to Supplier during such 30-calendar day periodPTC Territory, then BioForm and Supplier shall agree on a timeline for implementation of the Improvement in new Product Specifications for Company Product. If BioForm does not provide such a notice, said Enhancement shall not be implemented into the Company Product. The Enhancements Notice may also describe any potential Enhancements presented by Supplier at the Product Development Meeting, but BioForm shall not be required to take any action under this Section 8.4 with respect to such potential Enhancements until such time as they are presented by Supplier as Enhancements at a future Product Development Meeting. All Enhancements and potential Enhancement information provided by Supplier shall be considered Supplier Confidential Information. (b) From time any Material Change (as defined in the Ionis Pharmaceutical/Akcea License Agreements) prior to time, each party may request the other party to participate in joint projects to develop Improvementstheir implementation. Neither party is obligated to participate in If any such projects, and in each **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect activities are solely related to the omitted portions. instanceDevelopment of the Products in the PTC Territory, each party’s decision whether to participate then the Parties will be made in such party’s sole discretion. If both parties mutually agree to participate a budget for such activities, and the costs of such activities under such mutually agreed budget will be borne by PTC. 2.1.4 Akcea shall invite PTC to appoint a representative to attend, and such PTC representative shall be permitted to attend, any portions of any JSC or other Subcommittee meetings that are held pursuant to the Ionis Pharmaceuticals/Akcea License Agreements that relate to the Development of any of the Products in the PTC Territory. 2.1.5 PTC will conduct any Phase 4 Clinical Trials that are required or requested in writing by a Regulatory Authority in a country in the PTC Territory as a condition of, or in connection with, obtaining or maintaining Regulatory Approval in such a project country (a “Program”)whether such Phase 4 Clinical Trial is commenced prior to or after receipt of such Regulatory Approval) or as otherwise determined by PTC to conduct. As between Akcea and PTC, the parties will promptly prepare a mutually agreeable written development agreement specifying the development activities to be performed all costs and expenses incurred by and the research and development tasks assigned to each party (the “Development Agreement”). All allocation or on behalf of Intellectual Property rights with respect to any Program will be set forth in writing PTC in the Development Agreement. (c) In the absence performance of a Development Agreement, (i) BioForm and Supplier any such Phase 4 Clinical Trials shall retain joint ownership of Intellectual Property rights in which there is joint inventorship by BioForm (or its Affiliates) and Supplier, as determined in accordance with United States patent law, with Supplier’s rights in such joint ownership being subject to the license rights of BioForm under this Agreement, (ii) any Intellectual Property rights related to the Company Products, Enhancements, and Improvements that are created be borne solely by employees or consultants of Supplier during the Term shall be considered to be Intellectual Property rights of Supplier, subject to the license rights of BioForm under this Agreement, and (iii) any Intellectual Property rights related to the Company Products and Improvements that are created solely by employees or consultants of BioForm or any of its Affiliates during the Term shall be considered to be Intellectual Property rights of BioFormPTC. BioForm hereby grants to Supplier a perpetual, royalty free, world-wide, nonexclusive license to Supplier under such Blocking Intellectual Property to make, use, and sell such Intellectual Property outside the Field. “Blocking Intellectual Property” for the purposes of Section 8.4(c)(iii) shall mean Intellectual Property necessary for Supplier to make, use, or sell SA Product.ActiveUS 169009360v.1

Product Development. 2.1.1 As between Akcea and PTC, in the Akcea Territory, Akcea is solely responsible for the Development activities relating to the Products and AKCEA-TTR-LRx in accordance with the terms of the Ionis Pharmaceuticals/Akcea License Agreements, the Strategic Plans and Transition Plans (each as defined therein) and any Regulatory (as defined therein) strategies contemplated under the Ionis Pharmaceuticals/Akcea License Agreements. As between Akcea and PTC, all costs and expenses incurred by or on behalf of Akcea in the performance of such Development activities shall be borne solely by Akcea. 2.1.2 Akcea shall promptly notify PTC (but in any case within [**]) of any Material Changes (as defined in the Ionis Pharmaceuticals/Akcea License Agreements) to the Strategic Plans and any material changes to the Transition Plans that have been approved pursuant to the Ionis Pharmaceuticals/Akcea License Agreements that may affect the Development of the Products in the PTC Territory. 2.1.3 Akcea shall consult with PTC in good faith regarding (a) Supplier may develop enhancements it intends to incorporate into the BioGlue Surgical Adhesive during conduct and implementation of Akcea’s activities under the term of this Agreement that have potential application Strategic Plans and the Transition Plans relating to the Company Product (“Enhancements”). Unless otherwise agreed by the parties, at least once every six months during the Term, representatives of each of BioForm and Supplier shall hold a meeting in accordance with Sections 4.4 and 8.4 (the “Product Development Meeting”) at which Supplier will present Enhancements for BioForm to consider for application to the Company Product. At such Product Development Meeting, BioForm will also present its marketing plans (pursuant to Section 4.4) for the period and any information or feedback that BioForm reasonably believes may lead to Improvements. Within 30 calendar days following each Product Development Meeting, Supplier shall deliver a notice to BioForm (the “Enhancements Notice”) that shall describe the Enhancements that were presented by Supplier at such Product Development Meeting. Within 30 calendar days following receipt of the Enhancements Notice, BioForm may notify Supplier in writing if BioForm elects that any Enhancement described Products in the Enhancements Notice shall become an Improvement. If BioForm does provide such notice to Supplier during such 30-calendar day periodPTC Territory, then BioForm and Supplier shall agree on a timeline for implementation of the Improvement in new Product Specifications for Company Product. If BioForm does not provide such a notice, said Enhancement shall not be implemented into the Company Product. The Enhancements Notice may also describe any potential Enhancements presented by Supplier at the Product Development Meeting, but BioForm shall not be required to take any action under this Section 8.4 with respect to such potential Enhancements until such time as they are presented by Supplier as Enhancements at a future Product Development Meeting. All Enhancements and potential Enhancement information provided by Supplier shall be considered Supplier Confidential Information. (b) From time any Material Change (as defined in the Ionis Pharmaceutical/Akcea License Agreements) prior to time, each party may request the other party to participate in joint projects to develop Improvementstheir implementation. Neither party is obligated to participate in If any such projects, and in each **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect activities are solely related to the omitted portions. instanceDevelopment of the Products in the PTC Territory, each party’s decision whether to participate then the Parties will be made in such party’s sole discretion. If both parties mutually agree to participate a budget for such activities, and the costs of such activities under such mutually agreed budget will be borne by PTC. 2.1.4 Akcea shall invite PTC to appoint a representative to attend, and such PTC representative shall be permitted to attend, any portions of any JSC or other Subcommittee meetings that are held pursuant to the Ionis Pharmaceuticals/Akcea License Agreements that relate to the Development of any of the Products in the PTC Territory. 2.1.5 PTC will conduct any Phase 4 Clinical Trials that are required or requested in writing by a Regulatory Authority in a country in the PTC Territory as a condition of, or in connection with, obtaining or maintaining Regulatory Approval in such a project country (a “Program”)whether such Phase 4 Clinical Trial is commenced prior to or after receipt of such Regulatory Approval) or as otherwise determined by PTC to conduct. As between Akcea and PTC, the parties will promptly prepare a mutually agreeable written development agreement specifying the development activities to be performed all costs and expenses incurred by and the research and development tasks assigned to each party (the “Development Agreement”). All allocation or on behalf of Intellectual Property rights with respect to any Program will be set forth in writing PTC in the Development Agreement. (c) In the absence performance of a Development Agreement, (i) BioForm and Supplier any such Phase 4 Clinical Trials shall retain joint ownership of Intellectual Property rights in which there is joint inventorship by BioForm (or its Affiliates) and Supplier, as determined in accordance with United States patent law, with Supplier’s rights in such joint ownership being subject to the license rights of BioForm under this Agreement, (ii) any Intellectual Property rights related to the Company Products, Enhancements, and Improvements that are created be borne solely by employees or consultants of Supplier during the Term shall be considered to be Intellectual Property rights of Supplier, subject to the license rights of BioForm under this Agreement, and (iii) any Intellectual Property rights related to the Company Products and Improvements that are created solely by employees or consultants of BioForm or any of its Affiliates during the Term shall be considered to be Intellectual Property rights of BioForm. BioForm hereby grants to Supplier a perpetual, royalty free, world-wide, nonexclusive license to Supplier under such Blocking Intellectual Property to make, use, and sell such Intellectual Property outside the Field. “Blocking Intellectual Property” for the purposes of Section 8.4(c)(iii) shall mean Intellectual Property necessary for Supplier to make, use, or sell SA ProductPTC.

Product Development. (a) Supplier may develop enhancements it intends to incorporate into the BioGlue Surgical Adhesive during During the term of this Agreement that have potential application to the Company Product (“Enhancements”). Unless otherwise agreed by the partiesAgreement, SPL shall, at least once every six months during its expense, conduct a research and development program to evaluate Selected Compounds and Derivative Compounds as potential candidates for commercial development as Licensed Products. Such efforts may include the Termperformance of further medicinal chemical research based upon such Selected Compounds and Derivative Compounds, representatives as well as biological, pharmacokinetic and toxicology studies and other preclinical research activities. SPL shall have sole discretion over the scope of each such research and development program, and the selection of BioForm which Selected Compounds and Supplier shall hold a meeting in accordance with Sections 4.4 and 8.4 (Derivative Compounds will be the “Product Development Meeting”) at which Supplier will present Enhancements for BioForm to consider for application to the Company Product. At focus of such Product Development Meeting, BioForm will also present its marketing plans (pursuant to Section 4.4) for the period and any information or feedback that BioForm reasonably believes may lead to Improvements. Within 30 calendar days following each Product Development Meeting, Supplier shall deliver a notice to BioForm (the “Enhancements Notice”) that shall describe the Enhancements that were presented by Supplier at such Product Development Meeting. Within 30 calendar days following receipt of the Enhancements Notice, BioForm may notify Supplier in writing if BioForm elects that any Enhancement described in the Enhancements Notice shall become an Improvement. If BioForm does provide such notice to Supplier during such 30-calendar day period, then BioForm and Supplier shall agree on a timeline for implementation of the Improvement in new Product Specifications for Company Product. If BioForm does not provide such a notice, said Enhancement shall not be implemented into the Company Product. The Enhancements Notice may also describe any potential Enhancements presented by Supplier at the Product Development Meeting, but BioForm shall not be required to take any action under this Section 8.4 with respect to such potential Enhancements until such time as they are presented by Supplier as Enhancements at a future Product Development Meeting. All Enhancements and potential Enhancement information provided by Supplier shall be considered Supplier Confidential Informationactivities. (b) From time to time, each party may request the other party to participate in joint projects to develop Improvements. Neither party is obligated to participate in such projects, and in each **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. instance, each party’s decision whether to participate will be made in such party’s sole discretion. If both parties mutually agree to participate in such a project (a “Program”), the parties will promptly prepare a mutually agreeable written development agreement specifying the development activities to be performed by and the research and development tasks assigned to each party (the “Development Agreement”). All allocation of Intellectual Property rights with respect to any Program will be set forth SPL shall notify NeoGenesis in writing in the Development Agreementevent that SPL, in its sole discretion (based on SPL's good faith evaluation of the satisfaction of the applicable Success Criteria by such Selected Compound or Derivative Compound), decides to proceed with a development program for any Selected Compounds or Derivative Compounds as suitable candidates for drug development (thereafter, each a "DESIGNATED COMPOUND"). A Selected Compound or Derivative Compound will be deemed to be a Designated Compound upon the earlier of that date on which (i) SPL (or its Affiliate) formally approves proceeding with full *= CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. development of such Compound, or (ii) SPL (or its Affiliate) initiates IN VIVO toxicology trials necessary, and meeting U.S. FDA (or corresponding European or Japanese) standards, for obtaining approval for use of such Compound in human clinical trials, unless SPL sooner designates such Selected Compound or Derivative Compound as a Designated Compound with notice to NeoGenesis. Upon SPL's designation of a Designated Compound, SPL shall thereafter, at its expense, use Commercially Reasonable Efforts to develop and commercialize Licensed Products incorporating the Designated Compound in the Territory. SPL shall be solely responsible for determining in which countries in the Territory to develop and commercialize each Licensed Product, provided that it shall use Commercially Reasonable Efforts to obtain Regulatory Approval and to market and sell each Licensed Product in the Major Market Countries. (c) In the absence of a Development Agreement, (i) BioForm and Supplier shall retain joint ownership of Intellectual Property rights in which there is joint inventorship by BioForm (or its Affiliates) and Supplier, as determined in accordance with United States patent law, with Supplier’s rights in such joint ownership being subject Subject to the license rights of BioForm SPL's diligence obligations under this Agreement, (ii) any Intellectual Property rights related the Parties acknowledge and agree that all business decisions regarding research, development and commercialization of Designated Compounds and Licensed Products including, without limitation, decisions relating to the Company Productsdesign, Enhancementsdevelopment, manufacture, sale, price, distribution, marketing and Improvements that are created solely by employees or consultants promotion of Supplier during the Term shall be considered to be Intellectual Property rights of Supplier, subject to the license rights of BioForm Licensed Products under this Agreement, and the decision of whether to develop a particular Designated Compound, or to develop and commercialize a particular Licensed Product, shall be within the sole discretion of SPL. (iiid) any Intellectual Property rights related SPL shall have no quotas or other minimum diligence obligations with regard to the Company number of Designated Compounds and/or Licensed Products to be developed and Improvements commercialized hereunder. The parties acknowledge and agree that are created solely by employees or consultants of BioForm or any of its Affiliates during so long as SPL is using Commercially Reasonable Efforts to discover, develop and commercialize [*] Licensed Product in the Term Territory, SPL shall be considered deemed to be Intellectual Property rights of BioForm. BioForm hereby grants to Supplier a perpetual, royalty free, world-wide, nonexclusive license to Supplier in compliance with its diligence obligations under such Blocking Intellectual Property to make, use, and sell such Intellectual Property outside the Field. “Blocking Intellectual Property” for the purposes of Section 8.4(c)(iii) shall mean Intellectual Property necessary for Supplier to make, use, or sell SA Productthis Agreement.