Common use of Supply of Clinical Materials Clause in Contracts

Supply of Clinical Materials. During the Term of this Agreement, IMMUNOGEN shall supply to GENENTECH (or its Material Sublicensee) with such quantities of Clinical Materials as may be reasonably requested by GENENTECH (or its Material Sublicensee) in order to conduct all human clinical trials of Licensed Products through non-pivotal Phase II Clinical Studies. To the extent GENENTECH requests IMMUNOGEN to manufacture Clinical Materials as provided in the foregoing sentence, IMMUNOGEN and GENENTECH shall enter into separate supply and quality agreements detailing the terms of supply for any Clinical Materials that IMMUNOGEN is so requested to supply to GENENTECH for the purpose of conducting clinical trials. GENENTECH (or its Material Sublicensee) shall order all amounts of Clinical Materials, and IMMUNOGEN shall deliver all such ordered amounts, in accordance with forecasting parameters, advance ordering timeframes and delivery timeframes to be agreed upon by the Parties through the Collaboration Committee. IMMUNOGEN shall use its commercially reasonable efforts to deliver such amounts of Clinical Materials ordered in accordance with the foregoing (including such agreed upon timeframes) in a timely manner. In connection with any ordering of Clinical Materials by GENENTECH (or its Material Sublicensee), IMMUNOGEN shall provide GENENTECH (or its Material Sublicensee) promptly with IMMUNOGEN’s good faith estimate of the Fully 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, 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 local laws, and (b) it (as a matter of contract between itself and IMMUNOGEN) shall [***] all [***] for [***] that may arise from the [***] and [***] of such Clinical Materials to the extent 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 foregoing clause (a) of this Section 3.6.

Supply of Clinical Materials. During the Term of this Agreement, IMMUNOGEN shall supply to GENENTECH (or its Material Sublicensee) with such quantities of Clinical Materials as may be reasonably requested by GENENTECH (or its Material Sublicensee) in order to conduct all human clinical trials of Licensed Products through non-pivotal Phase II Clinical Studies. To the extent GENENTECH requests IMMUNOGEN to manufacture Clinical Materials as provided in the foregoing sentence, IMMUNOGEN and GENENTECH shall enter into separate supply and quality agreements detailing the terms of supply for any Clinical Materials that IMMUNOGEN is so requested to supply to GENENTECH for the purpose of conducting clinical trials. GENENTECH (or its Material Sublicensee) shall order all amounts of Clinical Materials, and IMMUNOGEN shall deliver all such ordered amounts, in accordance with forecasting parameters, advance ordering timeframes and delivery timeframes to be agreed upon by the Parties through the Collaboration Committee. IMMUNOGEN shall use its commercially reasonable efforts to deliver such amounts of Clinical Materials ordered in accordance with the foregoing (including such agreed upon timeframes) in a timely manner. In connection with any ordering of Clinical Materials by GENENTECH (or its Material Sublicensee), IMMUNOGEN shall provide GENENTECH (or its Material Sublicensee) promptly with IMMUNOGEN’s good faith estimate of the Fully 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, 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 local laws, and (b) it (as a matter of contract between itself and IMMUNOGEN) shall [***] all [***] for [***] that may arise from the [***] [***] and [***] of such Clinical Materials to the extent 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 foregoing clause (a) of this Section 3.6.

Supply of Clinical Materials. During In the event that, during the Term of this Agreement, ABX desires IMMUNOGEN shall to supply to GENENTECH (or its Material Sublicensee) ABX with such sufficient quantities of Clinical Materials as may be reasonably requested by GENENTECH (or its Material Sublicensee) in order to enable it to conduct all human clinical trials of Licensed Products through non-pivotal the conclusion of Phase II Clinical Studies, ABX shall provide IMMUNOGEN with written notice of same and the Parties shall negotiate in good faith and execute a supply agreement providing for such supply. To the extent GENENTECH requests IMMUNOGEN to manufacture Clinical Materials as provided in the foregoing sentence, IMMUNOGEN and GENENTECH shall enter into separate supply and quality agreements detailing the terms of supply for any Clinical Materials that IMMUNOGEN is so requested to supply to GENENTECH for the purpose of conducting clinical trials. GENENTECH (or its Material Sublicensee) shall order all amounts of Clinical Materials, and IMMUNOGEN shall deliver all such ordered amounts, amounts of Clinical Materials in accordance with forecasting parameters, advance ordering timeframes and delivery timeframes to be agreed upon by the Parties through the Collaboration Committee. IMMUNOGEN shall use its commercially reasonable efforts to deliver such amounts of Clinical Materials ordered in accordance with the foregoing (including mutually acceptable written supply agreement for such agreed upon timeframes) in a timely mannerpurpose. In connection with any ordering of Clinical Materials by GENENTECH (or its Material Sublicensee)ABX, IMMUNOGEN shall provide GENENTECH (or its Material Sublicensee) ABX promptly with IMMUNOGEN’s good faith estimate of the Fully Burdened Manufacturing Cost for manufacture and supply of such Clinical Materials. IMMUNOGEN’s price to supply Clinical Materials to GENENTECH (or its Material Sublicensee) ABX shall equal [***]% [ ] of IMMUNOGEN’S ’s Fully Burdened Manufacturing Cost for such Clinical Materials as approved by GENENTECH (or its Material Sublicensee)ABX. Nothing herein shall preclude GENENTECH ABX from making its own arrangements for manufacture and supply of Clinical Materials on its own or with Third Parties, in exercise of its license rights under Section 2.1. GENENTECH ABX hereby agrees that (a) it shall use the Clinical Materials in compliance with all applicable federal, state and local laws. IMMUNOGEN shall provide ABX with all information, filings and (b) it (assistance regarding manufacturing as a matter of contract between itself and IMMUNOGEN) shall [***] all [***] reasonably requested by ABX in connection with applications for [***] that may arise from the [***] and [***] of such Clinical Materials to the extent 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 foregoing clause (a) of this Section 3.6Regulatory Approvals.

Supply of Clinical Materials. During the Term of this Agreement, IMMUNOGEN shall supply to GENENTECH (or its Material Sublicensee) with such quantities of Clinical Materials as may be reasonably requested by GENENTECH (or its Material Sublicensee) in order to conduct all human clinical trials of Licensed Products through non-pivotal Phase II Clinical Studies. To the extent GENENTECH requests IMMUNOGEN to manufacture Clinical Materials as provided in the foregoing sentence, IMMUNOGEN and GENENTECH shall enter into separate supply and quality agreements detailing the terms of supply for any Clinical Materials that IMMUNOGEN is so requested to supply to GENENTECH for the purpose of conducting clinical trials. GENENTECH (or its Material Sublicensee) shall order all amounts of Clinical Materials, and IMMUNOGEN shall deliver all such ordered amounts, in accordance with forecasting parameters, advance ordering timeframes and delivery timeframes to be agreed upon by the Parties through the Collaboration Committee. IMMUNOGEN shall use its commercially reasonable efforts to deliver such amounts of Clinical Materials ordered in accordance with the foregoing (including such agreed upon timeframes) in a timely manner. In connection with any ordering of Clinical Materials by GENENTECH (or its Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. Material Sublicensee), IMMUNOGEN shall provide GENENTECH (or its Material Sublicensee) promptly with IMMUNOGEN’s good faith estimate of the Fully 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, 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 local laws, and (b) it (as a matter of contract between itself and IMMUNOGEN) shall [***] all [***] for [***] that may arise from the [***] and [***] of such Clinical Materials to the extent 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 foregoing clause (a) of this Section 3.6.

Supply of Clinical Materials. During the Term of this Agreement, IMMUNOGEN shall supply to GENENTECH (or its Material Sublicensee) with such quantities of Clinical Materials as may be reasonably requested by GENENTECH (or its Material Sublicensee) in order to conduct all human clinical trials of Licensed Products through non-pivotal Phase II Clinical Studies. To the extent GENENTECH requests IMMUNOGEN to manufacture Clinical Materials as provided in the foregoing sentence, IMMUNOGEN and GENENTECH shall enter into separate supply and quality agreements detailing the terms of supply for any Clinical Materials that IMMUNOGEN is so requested to supply to GENENTECH for the purpose of conducting clinical trials. GENENTECH (or its Material Sublicensee) shall order all amounts of Clinical Materials, and IMMUNOGEN shall deliver all such ordered amounts, in accordance with forecasting parameters, advance ordering timeframes and delivery timeframes to be agreed upon by the Parties through the Collaboration CommitteeJPDC. IMMUNOGEN shall use its commercially reasonable efforts to deliver such amounts of Clinical Materials ordered in accordance with the foregoing (including such agreed upon timeframes) in a timely manner. In connection with any ordering of Clinical Materials by GENENTECH (or its Material Sublicensee), IMMUNOGEN shall provide GENENTECH (or its Material Sublicensee) promptly with IMMUNOGEN’s good faith estimate of the Fully 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, 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 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 [***] use, storage and [***] disposal of such Clinical Materials to the extent 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 foregoing clause (a) of this Section 3.6.