Common use of Manufacturing Clause in Contracts

Manufacturing. Wyeth shall have the exclusive right to Manufacture Licensed Products itself or through one or more Third Parties selected by Wyeth; provided, however, that Trubion shall use its Commercially Reasonable Efforts to Manufacture and supply Wyeth with its requirements of the TRU-015 Product in accordance with the Development Plan under Trubion's existing contract Manufacturing arrangements for use in pre-clinical studies and clinical trials ("Clinical Study Supplies"); provided that Trubion cannot guarantee as of the Effective Date that it will be able to Manufacture and supply such requirements. Wyeth shall reimburse Trubion for its direct out-of-pocket cost of Clinical Study Supplies, including, without limitation, out-of-pocket expenses incurred by Trubion prior to the Effective Date that are directly related to the Manufacture, testing and release of Clinical Study Supplies to be used after the Effective Date (such pre-Effective Date out-of-pocket expenses not to exceed ***). Reimbursement of such pre-Effective Date expenses shall be due within thirty (30) days after the first patient is dosed in the first Phase IIb Clinical Study for rheumatoid arthritis using such Clinical Study Supplies. Upon Wyeth's written request, Trubion shall provide reasonable assistance to Wyeth, until the first cGMP batch of TRU-015 Product is Manufactured in a Wyeth facility (or the facility of a Third Party designated by Wyeth), in support and facilitation of Wyeth's efforts to Manufacture TRU-015 Products and to secure appropriate TRU-015 Product Manufacturing arrangements with Third Parties. Such assistance shall be at no cost to Wyeth; provided that Wyeth shall reimburse Trubion for all of its reasonable out-of-pocket expenses related thereto. If applicable, upon Wyeth's written request, Trubion shall assign or otherwise transfer to Wyeth (to the extent allowable under such agreements) its TRU-015 Product Manufacturing agreements with Third Parties.

Manufacturing. Wyeth Except as otherwise provided in this ------------- -------------- Agreement, the Research Plan or as LILLY and MEGABIOS may agree in writing, MEGABIOS shall be responsible for the development, manufacture and supply of Product material for preclinical testing and toxicology studies and material suitable for use in Phase I Clinical Trials as contemplated under this Agreement; [ * ] LILLY shall review, prior to Committee approval, all protocols for toxicology studies conducted under the terms of the Research Plan. All applicable manufacturing and toxicology facilities (and materials made under this Agreement) shall comply with and be operated in accordance with all applicable GMP, GLP, requirements specified in the IND, and [ * ] Certain information on this page has been omitted and filed separately with the Commission. Confidential Treatment has been requested with respect to the omitted portions. other regulatory requirements. LILLY shall have the exclusive right to Manufacture Licensed Products itself or through one or more Third Parties selected by Wyeth; providedaudit all manufacturing and toxicology facilities described herein, howeverincluding procedures and practices, that Trubion to verify their conformance with applicable GMP, GLP and other regulatory requirements. MEGABIOS shall use its Commercially Reasonable Efforts comply with all applicable governmental requirements, and shall provide LILLY with all information pertinent to Manufacture regulatory approvals for manufacturing facilities. Additionally, a Manufacturing Requirements Document will be developed and agreed to prior to the manufacture and supply Wyeth with its requirements of the TRU-015 first Phase I Clinical Trial Product material. An outline of the initial content for the Manufacturing Requirements Document is included in Appendix II. MEGABIOS shall provide to LILLY, in the format reasonably specified by LILLY, all information related to the chemistry manufacture and control of the Product required for regulatory submissions. Notwithstanding the foregoing, such manufacture and supply by MEGABIOS, together with other activities under the Project, shall not require expenditure by MEGABIOS beyond the funding provided in Section 3.1 below. MEGABIOS will operate under cGMP control which is appropriate to its Phase I clinical trial manufacturing activity, as described in the FDA Guideline on the Preparation of Investigational New Drug Products (Human and Animal), March 1991, or any applicable successor thereto. MEGABIOS will supply product manufactured in accordance with current GMP's and in compliance with the Development Plan under Trubionrequirements and specifications in LILLY's existing contract Manufacturing arrangements IND. LILLY, at its discretion, shall have the sole right (and responsibility related thereto) for use in pre-clinical studies and clinical trials ("Clinical Study Supplies"); provided that Trubion cannot guarantee as the manufacture of the Effective Date that it will be able to Manufacture and supply such requirements. Wyeth shall reimburse Trubion for its direct out-of-pocket cost of Clinical Study Suppliesall material, includingif any, without limitation, out-of-pocket expenses incurred by Trubion prior to the Effective Date that are directly related to the Manufacture, testing and release Product(s) beyond Phase I Clinical Trials. LILLY may appoint any Affiliate or third party to perform all or a portion of Clinical Study Supplies such manufacturing activities. Each appointee shall be required to be used after undertake in writing for the Effective Date (such pre-Effective Date out-of-pocket expenses benefit of MEGABIOS not to exceed ***). Reimbursement disclose any Manufacturing Information (as defined in Section 4.3) to any third party or to use such Manufacturing Information outside the scope of such pre-Effective Date expenses shall be due within thirty (30) days after the first patient is dosed license set forth in the first Phase IIb Clinical Study for rheumatoid arthritis using such Clinical Study Supplies. Upon Wyeth's written request, Trubion shall provide reasonable assistance to Wyeth, until the first cGMP batch of TRU-015 Product is Manufactured in a Wyeth facility (or the facility of a Third Party designated by Wyeth), in support and facilitation of Wyeth's efforts to Manufacture TRU-015 Products and to secure appropriate TRU-015 Product Manufacturing arrangements with Third Parties. Such assistance shall be at no cost to Wyeth; provided that Wyeth shall reimburse Trubion for all of its reasonable out-of-pocket expenses related thereto. If applicable, upon Wyeth's written request, Trubion shall assign or otherwise transfer to Wyeth (to the extent allowable under such agreements) its TRU-015 Product Manufacturing agreements with Third PartiesSection 5.1.

Manufacturing. Wyeth shall have the exclusive right to Manufacture Licensed Products itself or through one or more Third Parties selected by Wyeth; provided, however, that Trubion shall use its Commercially Reasonable Efforts to Manufacture and supply Wyeth with its requirements of the TRU-015 Product in accordance with the Development Plan under Trubion's existing contract Manufacturing arrangements for use in pre-clinical studies and clinical trials ("Clinical Study Supplies"); provided that Trubion cannot guarantee as of the Effective Date that it will be able to Manufacture and supply such requirements. Wyeth shall reimburse Trubion for its direct out-of-pocket cost of Clinical Study Supplies, including, without limitation, out-of-pocket expenses incurred by Trubion prior to the Effective Date that are directly related to the Manufacture, testing and release of Clinical Study Supplies to be used after the Effective Date (such pre-Effective Date out-of-pocket expenses not to exceed [***)]. Reimbursement of such pre-Effective Date expenses shall be due within thirty (30) days after the first patient is dosed in the first Phase IIb Clinical Study for rheumatoid arthritis using such Clinical Study Supplies. Upon Wyeth's written request, Trubion shall provide reasonable assistance to Wyeth, until the first cGMP batch of TRU-015 Product is Manufactured in a Wyeth facility (or the facility of a Third Party designated by Wyeth), in support and facilitation of Wyeth's efforts to Manufacture TRU-015 Products and to secure appropriate TRU-015 Product Manufacturing arrangements with Third Parties. Such assistance shall be at no cost to Wyeth; provided that Wyeth shall reimburse Trubion for all of its reasonable out-of-pocket expenses related thereto. If applicable, upon Wyeth's written request, Trubion shall assign or otherwise transfer to Wyeth (to the extent allowable under such agreements) its TRU-015 Product Manufacturing agreements with Third Parties.

Manufacturing. Wyeth shall have the exclusive right to Manufacture Licensed Products itself or through one or more Third Parties selected by Wyeth; provided, however, that Trubion shall use its Commercially Reasonable Efforts to Manufacture and supply Wyeth with its requirements of the TRU-015 Product in accordance with the Development Plan under Trubion's ’s existing contract Manufacturing arrangements for use in pre-clinical studies and clinical trials ("“Clinical Study Supplies"”); provided that Trubion cannot guarantee as of the Effective Date that it will be able to Manufacture and supply such requirements. Wyeth shall reimburse Trubion for its direct out-of-pocket cost of Clinical Study Supplies, including, without limitation, out-of-pocket expenses incurred by Trubion prior to the Effective Date that are directly related to the Manufacture, testing and release of Clinical Study Supplies to be used after the Effective Date (such pre-Effective Date out-of-pocket expenses not to exceed ***Three Million Dollars ($3,000,000)). Reimbursement of such pre-Effective Date expenses shall be due within thirty (30) days after the first patient is dosed in the first Phase IIb Clinical Study for rheumatoid arthritis using such Clinical Study Supplies. Upon Wyeth's ’s written request, Trubion shall provide reasonable assistance to Wyeth, until the first cGMP batch of TRU-015 Product is Manufactured in a Wyeth facility (or the facility of a Third Party designated by Wyeth), in support and facilitation of Wyeth's ’s efforts to Manufacture TRU-015 Products and to secure appropriate TRU-015 Product Manufacturing arrangements with Third Parties. Such assistance shall be at no cost to Wyeth; provided that Wyeth shall reimburse Trubion for all of its reasonable out-of-pocket expenses related thereto. If applicable, upon Wyeth's ’s written request, Trubion shall assign or otherwise transfer to Wyeth (to the extent allowable under such agreements) its TRU-015 Product Manufacturing agreements with Third Parties.