Common use of Supply of Clinical Materials by ImmunoGen Clause in Contracts

Supply of Clinical Materials by ImmunoGen. If, during the Term of this Agreement, Centocor requests in writing that ImmunoGen supply Centocor with such quantities of Clinical Materials as may be reasonably required by Centocor in order to conduct human clinical trials of such Clinical Materials through the completion of non-pivotal Phase II Clinical 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 Ace of 1934. Trials for such Clinical Materials, ImmunoGen will use commercially reasonable efforts to supply 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 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 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 the foregoing, Centocor 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 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 (including 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 Centocor, ImmunoGen shall provide Centocor promptly with ImmunoGen’s good faith estimate of the Cost for manufacture and supply of such Clinical Materials. The Supply Agreement shall provide that ImmunoGen’s price to supply Clinical Materials to Centocor shall equal [************************************] for such Clinical Materials. Centocor 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 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 Ace of 1934. use, storage and disposal of such Clinical Materials. 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 the foregoing clause (a) of this Section 4.3.

Appears in 1 contract

Samples: Development and License Agreement (Immunogen Inc)

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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, Centocor requests in writing that ImmunoGen shall, at Biogen Idec’s request, use reasonable commercial efforts to supply Centocor Biogen Idec with such quantities of Clinical Materials as may be reasonably required ordered by Centocor Biogen Idec in order to conduct connection with human clinical trials testing of such Clinical Materials through the completion of non-pivotal any Phase II Clinical Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant Trials deemed necessary by Biogen Idec. Should Biogen Idec determine in good faith that it plans to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934. Trials for such Clinical Materials, ImmunoGen will use commercially reasonable efforts to supply 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 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 request ImmunoGen to manufacture Clinical Materials as provided in the foregoing sentencessentence, ImmunoGen and Centocor Biogen Idec shall enter into a separate supply and quality agreements agreement detailing the terms of supply for any Clinical Materials that ImmunoGen is may be so requested to supply to Centocor 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”). The Supply Agreement will provide that Biogen Idec shall (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, Centocor Biogen Idec 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 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 (including 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 [************************] Antibodies Antibody from CentocorBiogen Idec. In connection with any ordering of Clinical Materials by CentocorBiogen Idec, ImmunoGen shall provide Centocor Biogen Idec promptly with ImmunoGen’s good faith estimate of the Cost for manufacture and supply of such Clinical Materials. The Supply Agreement shall provide that ImmunoGen’s price to supply Clinical Materials to Centocor Biogen Idec shall equal [******************] ([***************]) [***] for such Clinical Materials. Centocor Biogen Idec 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 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 Ace of 1934. 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. Centocor 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 the foregoing clause clauses (a) and (b) of this Section 4.34.3 and the Supply Agreement.

Appears in 1 contract

Samples: Development and License Agreement (Immunogen Inc)

Supply of Clinical Materials by ImmunoGen. If, during the Term of this Agreement, Centocor Bayer requests in writing that ImmunoGen supply Centocor Bayer with such quantities of Clinical Materials as may be reasonably required by Centocor Bayer in order to conduct human clinical trials studies of such Clinical Materials through the completion of non-pivotal Phase II Clinical 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 Ace of 1934. Trials Studies for such Clinical Materials, ImmunoGen will use commercially reasonable efforts to supply 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 Bayer with such Clinical Materials only pursuant 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 supply for any Clinical Materials that ImmunoGen is so requested to supply to Centocor for the purpose of conducting clinical trials, which a 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. Subject to the foregoingThe Supply Agreement shall provide, Centocor shall order all amounts of Clinical Materialsamong other things, and that (a) 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 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 ; (including such agreed upon timeframesb) 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 CentocorBayer, ImmunoGen shall provide Centocor promptly Bayer with ImmunoGen’s good faith estimate of the Cost for manufacture and supply of such Clinical Materials. The Supply Agreement shall provide that ; (c) ImmunoGen’s price to supply Clinical Materials to Centocor 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. Centocor 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 (ai) it shall use the Clinical Materials in compliance with all applicable federal, state and local laws, Applicable Laws and (bii) it (as a matter of contract between itself and ImmunoGen) shall assume all liability for damages that may arise from the 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 Ace of 1934. use, storage and disposal of such Clinical Materials. Centocor 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 the foregoing clause (a) all Applicable Laws. Portions of this Section 4.3Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Appears in 1 contract

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, Centocor requests in writing that ImmunoGen shall, at Biogen Idec’s request, use reasonable commercial efforts to supply Centocor Biogen Idec with such quantities of Clinical Materials as may be reasonably required ordered by Centocor Biogen Idec in order to conduct connection with human clinical trials testing of such Clinical Materials through the completion of non-pivotal any Phase II Clinical Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission Pursuant Trials deemed necessary by Biogen Idec. Should Biogen Idec determine in good faith that it plans to the Company’s application requesting confidential investment under Rule 24b-2 under the Securities Exchange Ace of 1934. Trials for such Clinical Materials, ImmunoGen will use commercially reasonable efforts to supply 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 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 request ImmunoGen to manufacture Clinical Materials as provided in the foregoing sentencessentence, ImmunoGen and Centocor Biogen Idec shall enter into a separate supply and quality agreements agreement detailing the terms of supply for any Clinical Materials that ImmunoGen is may be so requested to supply to Centocor 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”). The Supply Agreement will provide that Biogen Idec shall (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, Centocor Biogen Idec 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 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 (including 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 Antibody from CentocorBiogen Idec. In connection with any ordering of Clinical Materials by CentocorBiogen Idec, ImmunoGen shall provide Centocor Biogen Idec promptly with ImmunoGen’s good faith estimate of the Cost for manufacture and supply of such Clinical Materials. The Supply Agreement shall provide that ImmunoGen’s price to supply Clinical Materials to Centocor Biogen Idec shall equal [***] ([******************************]) [***] for such Clinical Materials. Centocor Biogen Idec 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 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 Ace of 1934. 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. Centocor 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 the foregoing clause clauses (a) and (b) of this Section 4.34.3 and the Supply Agreement.

Appears in 1 contract

Samples: Development and License Agreement (ImmunoGen, Inc.)

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Supply of Clinical Materials by ImmunoGen. If, during the Term of this Agreement, Centocor Bayer requests in writing that ImmunoGen supply Centocor Bayer with such quantities of Clinical Materials as may be reasonably required by Centocor Bayer in order to conduct human clinical trials studies of such Clinical Materials through the completion of non-pivotal Phase II Clinical 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 Ace of 1934. Trials Studies for such Clinical Materials, ImmunoGen will use commercially reasonable efforts to supply 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 Bayer with such Clinical Materials only pursuant 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 supply for any Clinical Materials that ImmunoGen is so requested to supply to Centocor for the purpose of conducting clinical trials, which a 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. Subject to the foregoingThe Supply Agreement shall provide, Centocor shall order all amounts of Clinical Materialsamong other things, and that (a) 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 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 ; (including such agreed upon timeframesb) 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 CentocorBayer, ImmunoGen shall provide Centocor promptly Bayer with ImmunoGen’s good faith estimate of the Cost for manufacture and supply of such Clinical Materials. The Supply Agreement shall provide that ; (c) ImmunoGen’s price to supply Clinical Materials to Centocor 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. Centocor 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 (ai) it shall use the Clinical Materials in compliance with all applicable federal, state and local laws, Applicable Laws and (bii) it (as a matter of contract between itself and ImmunoGen) shall assume all liability for damages that may arise from the Portions of this Exhibit Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Securities and Exchange Commission Pursuant pursuant to the CompanyRegistrant’s application requesting confidential investment under treatment pursuant to Rule 24b-2 under of the Securities Exchange Ace Act of 1934, as amended. arise from the use, storage and disposal of such Clinical Materials. Centocor 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 the foregoing clause (a) of this Section 4.3all Applicable Laws.

Appears in 1 contract

Samples: Development and License Agreement (Immunogen Inc)

Supply of Clinical Materials by ImmunoGen. If, during the Term of this Agreement, Centocor Bayer requests in writing that ImmunoGen supply Centocor Bayer with such quantities of Clinical Materials as may be reasonably required by Centocor Bayer in order to conduct human clinical trials studies of such Clinical Materials through the completion of non-pivotal Phase II Clinical 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 Ace of 1934. Trials Studies for such Clinical Materials, ImmunoGen will use commercially reasonable efforts to supply 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 Bayer with such Clinical Materials only pursuant 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 supply for any Clinical Materials that ImmunoGen is so requested to supply to Centocor for the purpose of conducting clinical trials, which a 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. Subject to the foregoingThe Supply Agreement shall provide, Centocor shall order all amounts of Clinical Materialsamong other things, and that (a) 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 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 ; (including such agreed upon timeframesb) 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 CentocorBayer, ImmunoGen shall provide Centocor promptly Bayer with ImmunoGen’s good faith estimate of the Cost for manufacture and supply of such Clinical Materials. The Supply Agreement shall provide that ; (c) ImmunoGen’s price to supply Clinical Materials to Centocor 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. Centocor 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 (ai) it shall use the Clinical Materials in compliance with all applicable federal, state and local laws, Applicable Laws and (bii) it (as a matter of contract between itself and ImmunoGen) shall assume all liability for damages that may arise from the Portions of this Exhibit Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Securities and Exchange Commission Pursuant pursuant to the CompanyRegistrant’s application requesting confidential investment under treatment pursuant to Rule 24b-2 under of the Securities Exchange Ace Act of 1934. use, storage and disposal of such Clinical Materials. 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 the foregoing clause (a) of this Section 4.3as amended.

Appears in 1 contract

Samples: Development and License Agreement (Immunogen Inc)

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