Supply of Clinical Materials by ImmunoGen. If, during the Term of this Agreement, Bayer requests in writing that ImmunoGen supply Bayer with such quantities of Clinical Materials as may be reasonably required by Bayer in order to conduct human clinical studies of such Clinical Materials through the completion of non-pivotal Phase II Clinical Studies for such Clinical Materials, ImmunoGen will use commercially reasonable efforts to supply Bayer with such Clinical Materials pursuant to the terms of a supply agreement (the “Supply Agreement”) to be negotiated in good faith by the Parties. The Supply Agreement shall provide, among other things, that (a) ImmunoGen shall deliver all ordered amounts of Clinical Materials in accordance with forecasting parameters, advance ordering timeframes and delivery timeframes to be agreed upon by the Parties in the Supply Agreement; (b) in connection with any ordering of Clinical Materials by Bayer, ImmunoGen shall provide Bayer with ImmunoGen’s good faith estimate of the Cost for manufacture and supply of such Clinical Materials; (c) ImmunoGen’s price to supply Clinical Materials to Bayer shall equal [***] for such Clinical Materials; and (d) Bayer shall use such Clinical Materials solely for human clinical testing up to and including conduct of non-pivotal Phase II Clinical Studies. The Supply Agreement may take the form of a master supply agreement, together with work orders specifically related to the supply of Clinical Materials. Further, the Parties shall enter into such additional agreements related to GMP, quality and technical terms as are necessary for regulatory purposes. Bayer hereby agrees that (i) it shall use the Clinical Materials in compliance with all Applicable Laws and (ii) 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. Bayer 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 all Applicable Laws.
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Samples: Development and License Agreement (Immunogen Inc), Development and License Agreement (Immunogen Inc)
Supply of Clinical Materials by ImmunoGen. If, during the Term of this Agreement, Bayer requests in writing that ImmunoGen supply Bayer with such quantities of Clinical Materials as may be reasonably required by Bayer in order to conduct human clinical studies of such Clinical Materials through the completion of non-pivotal Phase II Clinical Studies for such Clinical Materials, ImmunoGen will use commercially reasonable efforts to supply Bayer with such Clinical Materials pursuant to the terms of a supply agreement (the “Supply Agreement”) to be negotiated in good faith by the Parties. The Supply Agreement shall provide, among other things, that (a) ImmunoGen shall deliver all ordered amounts of Clinical Materials in accordance with forecasting parameters, advance ordering timeframes and delivery timeframes to be agreed upon by the Parties in the Supply Agreement; (b) in connection with any ordering of Clinical Materials by Bayer, ImmunoGen shall provide Bayer with ImmunoGen’s good faith estimate of the Cost for manufacture and supply of such Clinical Materials; (c) ImmunoGen’s price to supply Clinical Materials to Bayer shall equal [***] for such Clinical Materials; and (d) Bayer shall use such Clinical Materials solely for human clinical testing up to and including conduct of non-pivotal Phase II Clinical Studies. The Supply Agreement may take the form of a master supply agreement, together with work orders specifically related to the supply of Clinical Materials. Further, the Parties shall enter into such additional agreements related to GMP, quality and technical terms as are necessary for regulatory purposes. Bayer hereby agrees that (i) it shall use the Clinical Materials in compliance with all Applicable Laws and (ii) 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. Bayer 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 all Applicable Laws.may
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Supply of Clinical Materials by ImmunoGen. If, during the Term of this Agreement, Bayer Centocor requests in writing that ImmunoGen supply Bayer Centocor with such quantities of Clinical Materials as may be reasonably required by Bayer Centocor in order to conduct human clinical studies trials of such Clinical Materials through the completion of non-pivotal Phase II Clinical Studies Trials for such Clinical Materials, ImmunoGen will use commercially reasonable efforts to supply Bayer Centocor with such Clinical Materials. If, during the Term of this Agreement, Centocor requests in writing that ImmunoGen supply it with Clinical Materials in connection with the conduct of Pivotal Clinical Trials, ImmunoGen will supply Centocor with such Clinical Materials pursuant only to the extent ImmunoGen has the capability to do so at the time of Centocor’s request. In either event, the Parties shall share information concerning specifications, forecasting and capacity requirements in order to adequately plan for the manufacture of such Clinical Materials. To the extent Centocor requests ImmunoGen to manufacture Clinical Materials as provided in the foregoing sentences, ImmunoGen and Centocor shall enter into a separate supply and quality agreements detailing the terms of a supply for any Clinical Materials that ImmunoGen is so requested to supply to Centocor for the purpose of conducting clinical trials, which supply agreement shall include, without limitation, the terms set forth on Schedule B attached hereto and the remainder of this Section 4.3 (the “Supply Agreement”) ). Subject to be negotiated in good faith by the Parties. The Supply Agreement foregoing, Centocor shall provideorder all amounts of Clinical Materials, among other things, that (a) and ImmunoGen shall deliver all such ordered amounts of Clinical Materials amounts, in accordance with forecasting parameters, advance ordering timeframes and delivery timeframes to be agreed upon by the Parties in the Supply Agreement; . The Supply Agreement further shall provide that ImmunoGen shall use commercially reasonable efforts to deliver such amounts of Clinical Materials ordered in accordance with the foregoing (bincluding such agreed upon timeframes) in a timely manner; provided, that, ImmunoGen’s obligations shall be contingent on ImmunoGen’s receipt of the required quantities of [************************] Antibodies from Centocor. In connection with any ordering of Clinical Materials by BayerCentocor, ImmunoGen shall provide Bayer Centocor promptly with ImmunoGen’s good faith estimate of the Cost for manufacture and supply of such Clinical Materials; (c) . The Supply Agreement shall provide that ImmunoGen’s price to supply Clinical Materials to Bayer Centocor shall equal [************************************] for such Clinical Materials; and (d) Bayer shall use such Clinical Materials solely for human clinical testing up to and including conduct of non-pivotal Phase II Clinical Studies. The Supply Agreement may take the form of a master supply agreement, together with work orders specifically related to the supply of Clinical Materials. Further, the Parties shall enter into such additional agreements related to GMP, quality and technical terms as are necessary for regulatory purposes. Bayer Centocor hereby agrees that (ia) it shall use the Clinical Materials in compliance with all Applicable Laws applicable federal, state and local laws, and (iib) 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. Bayer Centocor 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 all Applicable Lawsthe foregoing clause (a) of this Section 4.3.
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Supply of Clinical Materials by ImmunoGen. IfNotwithstanding anything to the contrary in Section 4.1, during the Term of this Agreement, Bayer requests in writing that ImmunoGen shall, at Biogen Idec’s request, use reasonable commercial efforts to supply Bayer Biogen Idec with such quantities of Clinical Materials as may be reasonably required ordered by Bayer Biogen Idec in order to conduct connection with human clinical studies testing of such Clinical Materials through the completion of non-pivotal any Phase II Clinical Studies for such Trials deemed necessary by Biogen Idec. Should Biogen Idec determine in good faith that it plans to request ImmunoGen to manufacture Clinical MaterialsMaterials as provided in the foregoing sentence, ImmunoGen will use commercially reasonable efforts to supply Bayer with such Clinical Materials pursuant to and Biogen Idec shall enter into a separate agreement detailing the terms of a supply for any Clinical Materials that ImmunoGen may be so requested to supply to Biogen Idec for the purpose of conducting clinical trials, which supply agreement shall include, without limitation, the terms set forth on Schedule B attached hereto and the remainder of this Section 4.3 (the “Supply Agreement”) to be negotiated in good faith by the Parties). The Supply Agreement will provide that Biogen Idec shall provide, among other things, that (a) provide ImmunoGen with a non-binding forecast of the quantity of Clinical Materials it reasonably expects to order over the succeeding [***] ([***]) month period and (b) supply ImmunoGen with quantities of bulk [***] Antibody sufficient to enable ImmunoGen to produce the quantity of Clinical Materials so requested. Subject to the foregoing, Biogen Idec shall order all amounts of Clinical Materials, and ImmunoGen shall deliver all such ordered amounts of Clinical Materials amounts, in accordance with forecasting parameters, advance ordering timeframes and delivery timeframes to be agreed upon by the Parties in the Supply Agreement; . The Supply Agreement further shall provide that ImmunoGen shall use commercially reasonable efforts to deliver such amounts of Clinical Materials ordered in accordance with the foregoing (bincluding such agreed upon timeframes) in a timely manner; provided, that, ImmunoGen’s obligations shall be contingent on ImmunoGen’s receipt of the required quantities of [***] Antibody from Biogen Idec. In connection with any ordering of Clinical Materials by BayerBiogen Idec, ImmunoGen shall provide Bayer Biogen Idec promptly with ImmunoGen’s good faith estimate of the Cost for manufacture and supply of such Clinical Materials; (c) . The Supply Agreement shall provide that ImmunoGen’s price to supply Clinical Materials to Bayer Biogen Idec shall equal [***] ([***]) [***] for such Clinical Materials; and (d) Bayer shall use such Clinical Materials solely for human clinical testing up to and including conduct of non-pivotal Phase II Clinical Studies. The Supply Agreement may take the form of a master supply agreement, together with work orders specifically related to the supply of Clinical Materials. Further, the Parties shall enter into such additional agreements related to GMP, quality and technical terms as are necessary for regulatory purposes. Bayer Biogen Idec hereby agrees that (ia) it shall use the Clinical Materials in compliance with all Applicable Laws applicable federal, state and local laws, and (iib) 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, unless such liability results from the gross negligence or willful misconduct of ImmunoGen or its Affiliates or their respective employees or agents. Bayer Biogen Idec 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 all Applicable Lawsthe foregoing clauses (a) and (b) of this Section 4.3 and the Supply Agreement.
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Samples: Development and License Agreement (ImmunoGen, Inc.)
Supply of Clinical Materials by ImmunoGen. IfNotwithstanding anything to the contrary in Section 4.1, during the Term of this Agreement, Bayer requests in writing that ImmunoGen shall, at Biogen Idec’s request, use reasonable commercial efforts to supply Bayer Biogen Idec with such quantities of Clinical Materials as may be reasonably required ordered by Bayer Biogen Idec in order to conduct connection with human clinical studies testing of such Clinical Materials through the completion of non-pivotal any Phase II Clinical Studies for such Trials deemed necessary by Biogen Idec. Should Biogen Idec determine in good faith that it plans to request ImmunoGen to manufacture Clinical MaterialsMaterials as provided in the foregoing sentence, ImmunoGen will use commercially reasonable efforts to supply Bayer with such Clinical Materials pursuant to and Biogen Idec shall enter into a separate agreement detailing the terms of a supply for any Clinical Materials that ImmunoGen may be so requested to supply to Biogen Idec for the purpose of conducting clinical trials, which supply agreement shall include, without limitation, the terms set forth on Schedule B attached hereto and the remainder of this Section 4.3 (the “Supply Agreement”) to be negotiated in good faith by the Parties). The Supply Agreement will provide that Biogen Idec shall provide, among other things, that (a) provide ImmunoGen with a non-binding forecast of the quantity of Clinical Materials it reasonably expects to order over the succeeding [***] ([***]) month period and (b) supply ImmunoGen with quantities of bulk [***] Antibody sufficient to enable ImmunoGen to produce the quantity of Clinical Materials so requested. Subject to the foregoing, Biogen Idec shall order all amounts of Clinical Materials, and ImmunoGen shall deliver all such ordered amounts of Clinical Materials amounts, in accordance with forecasting parameters, advance ordering timeframes and delivery timeframes to be agreed upon by the Parties in the Supply Agreement; . The Supply Agreement further shall provide that ImmunoGen shall use commercially reasonable efforts to deliver such amounts of Clinical Materials ordered in accordance with the foregoing (bincluding such agreed upon timeframes) in a timely manner; provided, that, ImmunoGen’s obligations shall be contingent on ImmunoGen’s 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 investment under Rule 24b-2 under the Securities Exchange Act of 1934. receipt of the required quantities of [***] Antibody from Biogen Idec. In connection with any ordering of Clinical Materials by BayerBiogen Idec, ImmunoGen shall provide Bayer Biogen Idec promptly with ImmunoGen’s good faith estimate of the Cost for manufacture and supply of such Clinical Materials; (c) . The Supply Agreement shall provide that ImmunoGen’s price to supply Clinical Materials to Bayer Biogen Idec shall equal [******************] ([***]) [***] for such Clinical Materials; and (d) Bayer shall use such Clinical Materials solely for human clinical testing up to and including conduct of non-pivotal Phase II Clinical Studies. The Supply Agreement may take the form of a master supply agreement, together with work orders specifically related to the supply of Clinical Materials. Further, the Parties shall enter into such additional agreements related to GMP, quality and technical terms as are necessary for regulatory purposes. Bayer Biogen Idec hereby agrees that (ia) it shall use the Clinical Materials in compliance with all Applicable Laws applicable federal, state and local laws, and (iib) 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, unless such liability results from the gross negligence or willful misconduct of ImmunoGen or its Affiliates or their respective employees or agents. Bayer Biogen Idec 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 all Applicable Lawsthe foregoing clauses (a) and (b) of this Section 4.3 and the Supply Agreement.
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