Common use of Technology Transfer Clause in Contracts

Technology Transfer. Subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo.

Appears in 3 contracts

Sources: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.), License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.), License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)

Technology Transfer. Subject During the term of this Agreement, Gilead will make the following technology transfers available to Licensee: (a) Within ninety (90) days following the Effective Date, Gilead will make a one-time technology transfer available to Licensee of know-how owned or controlled by Gilead as of the Effective Date relating to the manufacture of Sof and Sof Product to the extent and in the manner specified in Appendix 3 hereto. (b) Within ninety (90) days following Gilead’s receipt of marketing approval from the FDA for a Sof/LDV Product, Gilead will make a one-time technology transfer available to Licensee of know-how owned or controlled by Gilead relating to the manufacture of LDV and Sof/LDV Product to the extent and in the manner specified in Appendix 3 hereto. (c) Within ninety (90) days following Gilead’s receipt of marketing approval from the FDA for an LDV Product, Gilead will make a one-time technology transfer available to Licensee of know-how owned or controlled by Gilead relating to the manufacture of LDV Product to the extent and in the manner specified in Appendix 3 hereto. With respect to each of the foregoing technology transfers, Licensee shall notify Gilead of its desire to receive such technology transfer within the time period therefor, and following receipt of such notice Gilead will promptly make the applicable technology transfer. If Licensee does not notify Gilead of its desire to receive a particular technology transfer within the time period therefor, then Gilead will be under no obligation to make such technology transfer. The know-how transferred to Licensee pursuant to the terms of the Development Supply Agreementthis Section 5.5 shall be sufficient to enable Licensee to manufacture API, Sof Product, Sof/LDV Product and LDV Product, as soon as reasonably practicableapplicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Knowat commercial-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activitiesscale quantities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam Gilead shall have no obligations further obligation to transfer any other know-how under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCothis Agreement.

Appears in 3 contracts

Sources: License Agreement, License Agreement, License Agreement

Technology Transfer. Subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s 's expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s 's written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s 's written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo.

Appears in 2 contracts

Sources: License and Collaboration Agreement (Medicines Co /De), License and Collaboration Agreement (Medicines Co /De)

Technology Transfer. Subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology In its transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed ProductTechnology to ATS, CMI shall provide such reasonable training and documentation to ATS to enable ATS to obtain ISO 9002 certification and FDA GMP/QSR approval of the Production Line and the Licensed Product made thereon. To the extent that CMI documentation ("CMI Documentation") for the Licensed Technology is to be transferred hereunder, CMI shall provide one (1) legible hard copy of each manual or other documentation package or the electronic files thereof in Microsoft Word or Excel format or such other computer-aided design data used by CMI to manufacture Licensed Product in a format readable using commercially available software. CMI hereby grants ATS a non-exclusive, royalty-free, worldwide license to make, distribute and use such internal copies and derivative works of the CMI Documentation as are reasonably necessary to use the Licensed Technology for the purposes hereof, provided each such copy or derivative work shall retain any CMI copyright, trademark or other proprietary notices as are contained in the original version thereof, and shall make available its personnel on a reasonable basis provided further that ATS agrees to consult with MedCo pay any license fees or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam additional software development costs in connection with such herewith. Within ninety (90) days of the effective date of this Agreement, the parties shall adopt a mutually acceptable training and technology transfer activitiesplan to enable selected ATS managers, engineers and other staff to acquire and master the Licensed Technology, including, where appropriate, a system for CMI to "train the trainers." After the third anniversary date of this Agreement, CMI may notify ATS in writing that it is ready to initiate its transfer to ATS of the Licensed Technology, equipment and machining specifications and operating capability to permit ATS to develop the capability to internally machine graphite parts (the "Graphite Capability"), machine pyrolytic carbon coated parts (the "Pyrolytic Carbon Capability"), and develop its own tooling parts (the "Tooling Capability") (the date of such notification respectively referred to herein as the "Graphite Notice Date", the "Pyrolytic Carbon Notice Date" and the "Tooling Notice Date"). MedCo ATS shall reimburse Alnylam notify CMI in writing within thirty (30) business days of the Graphite Notice Date, the Pyrolytic Carbon Notice Date and the Tooling Notice Date, as applicable, whether it intends to proceed to develop the Graphite Capability, the Pyrolytic Carbon Capability, or the Tooling Capability, as applicable (respectively the "Graphite Decision Date", the "Pyrolytic Carbon Decision Date"and the "Tooling Decision Date"). If ATS fails to provide such Costs incurred with respect a notification, such action shall be deemed to be a decision not to develop such Manufacturing technology capability. After the third anniversary date of this Agreement, ATS may notify CMI in writing that it is ready to receive transfer to ATS of the Graphite Capability, the Pyrolytic Carbon Capability, and the Tooling Capability. CMI will use its best efforts to commence transfer of such capability within [***] days six (6) months after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedConotice from ATS.

Appears in 1 contract

Sources: Carbon Agreement (Ats Medical Inc)

Technology Transfer. Subject Licensee acknowledges that as of the Amended and Restated Effective Date Gilead has made the one-time technology transfers available to Licensee of know-how owned or controlled by Gilead relating to the manufacture of Sof, LDV, Vel, Sof Product, LDV Product, Vel Product, Sof/Vel Product, and Sof/LDV Product, in each case as described in Appendix 3 hereto. Licensee further acknowledges that the foregoing technology transfers are sufficient to enable Licensee to manufacture Sof, LDV, Vel, Sof Product, LDV Product, Vel Product, Sof/Vel Product, and Sof/LDV Product, as applicable, at commercial-scale quantities. Additionally, during the term of this Agreement: (a) within ninety (90) days following Gilead’s receipt of marketing approval from the FDA for a Sof/Vel/Vox Product, Gilead will make a one-time technology transfer available to Licensee of know-how owned or controlled by Gilead relating to the manufacture of such Sof/Vel/Vox Product to the extent and in the manner specified in Appendix 3 hereto, and (b) within ninety (90) days following Gilead’s receipt of marketing approval from the FDA for a Vox Product, Gilead will make a one-time technology transfer available to Licensee of know-how owned or controlled by Gilead relating to the manufacture of such Vox Product, to the extent and in the manner specified in Appendix 3 hereto. With respect to each of the foregoing technology transfers, Licensee shall notify Gilead of its desire to receive such technology transfer within the time period therefor, and following receipt of such notice Gilead will promptly make the applicable technology transfer. If Licensee does not notify Gilead of its desire to receive a particular technology transfer within the time period therefor, then Gilead will be under no obligation to make such technology transfer. The know-how transferred to Licensee pursuant to the terms of the Development Supply Agreementthis Section 5.5 shall be sufficient to enable Licensee to manufacture Vox, Vox Product and Sof/Vel/Vox Product, as soon as reasonably practicableapplicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Knowat commercial-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activitiesscale quantities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam Gilead shall have no obligations further obligation to transfer any other know-how under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCothis Agreement.

Appears in 1 contract

Sources: License Agreement

Technology Transfer. Subject [***] Research Program Opt-In Effective Date for a Research Program, MacroGenics will provide Gilead with copies of all MacroGenics Research Know-How (other than MacroGenics Research Know-How relating to the terms Manufacture of the Development Supply Agreementapplicable Research Molecules and Research Products, as soon as reasonably practicablethe initial transfer of which will be performed in accordance with Section 9.4 (Manufacturing Technology Transfer)) that [***] Research Molecules and Research Products. To facilitate each such transfer, but in no event later than the fifth Parties may mutually agree upon a written technology transfer plan to such MacroGenics Research Know-How (5th) anniversary “Research Program Technology Transfer Plan”), which will set forth a process and schedule for the transfer of such MacroGenics Research Know-How, projected levels of support to be provided by each Party, allocation among the Parties of the Effective Date, Alnylam shall initiate a major activities for such technology transfer and an overall timeline for its progress and completion. Each Party shall complete the activities allocated 44 to MedCoit under each Research Program Technology Transfer Plan (if any such plan is agreed upon). Thereafter, or on a periodic basis [***] MacroGenics Research Know-How (the “Research Program Technology Transfer Period”) as Gilead may reasonably request, MacroGenics will provide to its Third Party manufacturer(s) Gilead copies of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam all MacroGenics Research Know-How that is reasonably necessary (a) created, developed, invented or useful for otherwise made in the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt MacroGenics Research Know-How, [***] Research Molecules and Research Products in accordance with the terms of an invoice thereforthis Agreement [***] Research Plan. Alnylam and In addition to providing copies of the MacroGenics Research Know-How in accordance with this Section 5.9 (Technology Transfer), MacroGenics will make its Affiliates shall keep complete and accurate records in sufficient detail personnel reasonably available to Gilead during the Research Program Technology Transfer Period, at Gilead’s expense, so as to enable Gilead to practice under the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage MacroGenics Technology in connection with the Exploitation of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product applicable Research Molecules and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Research Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer Other than as set forth in the preceding sentence, [***] MacroGenics Research Know- How in accordance with this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo5.9 (Technology Transfer).

Appears in 1 contract

Sources: Collaboration and License Agreement (Macrogenics Inc)

Technology Transfer. Subject to After the terms Effective Date and promptly upon written request by Metagenomi (and in any event within ninety (90) days following designation of the Development Supply Agreementapplicable CMO (as defined below), as soon as reasonably practicableprovided that such CMO is able to support this timeline), but in no event later than the fifth (5th) anniversary Acuitas will conduct a single full transfer of the Effective Datethen-current formulation process, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo raw materials supply and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful analytical characterization for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage manufacture of the Licensed Product supply chain (i.e.the “Transferred Technology”), Bulk Drug Substanceto Metagenomi or a single cGMP contract manufacturing organization (“CMO”) designated by Metagenomi and subject to Acuitas’ prior written consent, Bulk Drug Product and Finished Productwhich will not be unreasonably withheld, conditioned or delayed the (“Technology Transfer”) pursuant to a mutually agreed plan (the “Technology Transfer Plan”). Promptly after MedCo’s written requestFor clarity, Alnylam shall use Commercially Reasonable Efforts it will not be unreasonable for Acuitas to assign withhold consent if it provides credible evidence that the CMO is subject to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related Deficiency. Acuitas consents to the CMOs set forth on Appendix 2.3. (Acuitas will provide reasonable assistance to enable such CMO to manufacture such Licensed Product. Initiation of such technology transfer will be determined by Metagenomi and will be for the then- current formulation of Licensed ProductsProduct. Such assignment shall Acuitas will be subject reimbursed for such activities by Metagenomi on an FTE basis and Metagenomi will also be responsible for all external costs incurred by Acuitas relating to transfer of Licensed Product formulation to such CMO, provided such costs have been approved by Metagenomi in advance. For clarity, the terms then-current formulation of Licensed Product will mean a single LNP formulation previously tested by Metagenomi in accordance with the Workplan (as defined in the Development and conditions Option Agreement). Once such Licensed Product formulation is transferred to such CMO, Metagenomi will assume responsibilities for future manufacturing of such agreementLicensed Product. If Metagenomi determines, including any required consents of such Third Party in Metagenomi’s sole discretion, that Metagenomi has a bona fide reason to engage a subsequent, additional or different CMO (the “Subsequent CMO”) after the Initial Technology Transfer, Acuitas will provide reasonable assistance to Metagenomi and MedCo’s written agreement the Subsequent CMO to assume all the obligations of Alnylam under such agreement to be undertaken after such assignmenttransfer Know- How relating then-current formulation process, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentenceraw materials supply, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) analytical characterization for the supply manufacture of such Licensed Product (a “Subsequent Technology Transfer” and Alnylam shall have no obligations under together with the Initial Technology Transfer, the “Technology Transfer”). Acuitas will provide reasonably requested ongoing technical support if requested by Metagenomi with such agreement between MedCo support reimbursed on a reasonable time, materials, and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoFTE basis.

Appears in 1 contract

Sources: Non Exclusive License Agreement (Metagenomi, Inc.)

Technology Transfer. Subject A. In addition to the terms granting of the Development Supply Agreementaforesaid licenses under the Technology, as soon as reasonably practicableupon Effective Date of this Agreement and the payment of the portion of the License Fee described in Paragraph III.A. above Tessera will transfer to Licensee, but in no event not later than the fifth thirty (5th30) anniversary of days from the Effective Date, Alnylam shall initiate a technology transfer to MedCocertain of the Technology, or to its Third Party manufacturer(s) of Licensed Productincluding certain TCC package specifications, selected by MedCo Standards and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful certain Technical Information for the Manufacture TCC packages licensed herein. B. Tessera will make available on at least a semiannual basis, improvements which have been reduced to practice including changes and modifications in Standards, methods, materials and specifications during the term of this Agreement through Tessera's regularly published Technical Briefing Bulletin or substantially equivalent method. Notwithstanding the foregoing, Tessera is under no obligation to transfer and/or license any information whether confidential, proprietary or otherwise that it may be prohibited from transferring to Licensee by contract with a third party or applicable law. In the case Tessera proposes to transfer proprietary or Confidential information to Licensee, Tessera will first provide Licensee a non-confidential outline of the Licensed Productproposed Confidential information, but shall not undertake or complete any transfer unless it first receives Licensee's written acknowledgment and approval. Notwithstanding any provision to the contrary, Tessera shall not be under any obligation to transfer or disclose actual patent applications or related documents to Licensee. C. For a period of up to twelve (12) months commencing with the Effective Date of this Agreement, and shall according to a mutually agreeable time schedule and manpower assignment schedule, Tessera will make certain of its engineering staff available at its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expenseSan Jose ▇▇▇ilities for transfer activities, including joint activities with Licensee's engineers, as may be necessary in accordance with mutual agreement of the Costs reasonably parties to successfully complete the Technology transfer; provided, Tessera shall provide up to sixty (60) working man days of engineering support during first twelve month period for such transfer activity. If at the end of such transfer activity, Licensee has a good faith belief that more training is needed in certain technical areas, Licensee shall specifically define such technical areas to Tessera in writing and Tessera shall then provide up to an additional thirty (30) working man-days of engineering support for the Licensee defined technical areas during first twelve month period for such transfer activity. Licenser agrees to pay all reasonable coach class air travel and hotel charges incurred by Alnylam Tessera personnel in connection with such technology transfer activitiesengineering support performed at any of Licensee's facilities outside of San Jose. MedCo ▇▇ditional engineering interactions, conducted to collaborate on technical issues of mutual concern, shall reimburse Alnylam such Costs incurred be supported by each party at its own expense. D. Additional engineering support (not to exceed sixty (60) working days) beyond the initial twelve month period for an additional twelve (12) month period may be made available, according to a mutually agreeable time schedule and manpower assignment schedule, at a per diem rate of US $[*] per support engineer, plus reasonable air travel and hotel charges. Any * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice thereforthe omitted portions. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to Tessera Confidential support or other services required thereafter may be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related provided upon terms mutually agreeable to the manufacture parties. E. Tessera represents that the Technical information provided hereunder will be prepared with reasonable care and warrants that the Technical Information will, where applicable for similar types of Licensed Products. Such assignment shall TCC or related IC packages, be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all same as the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoTechnical Information used by Tessera.

Appears in 1 contract

Sources: TCC License Agreement (Tessera Inc)

Technology Transfer. Subject During the term of this Agreement, Cytocom will make the following technology transfers available to Licensee: (a) Within ninety (90) days following the Effective Date, Cytocom will make a one-time technology transfer available to Licensee of know-how owned or controlled by Cytocom as of the Effective Date relating to the manufacture of NTX and NTX Product to the extent and in the manner specified in Appendix 3 hereto. (b) Within ninety (90) days following Cytocom’s receipt of marketing approval from the FDA for a NTX/M▇▇▇ Product, Cytocom will make a one-time technology transfer available to Licensee of know-how owned or controlled by Cytocom relating to the manufacture of M▇▇▇ and NTX/M▇▇▇ Product to the extent and in the manner specified in Appendix 3 hereto. (c) Within ninety (90) days following Cytocom’s receipt of marketing approval from the FDA for an M▇▇▇ Product, Cytocom will make a one-time technology transfer available to Licensee of know-how owned or controlled by Cytocom relating to the manufacture of M▇▇▇ Product to the extent and in the manner specified in Appendix 3 hereto. With respect to each of the foregoing technology transfers, Licensee shall notify Cytocom of its desire to receive such technology transfer within the time period therefor, and following receipt of such notice Cytocom will promptly make the applicable technology transfer. If Licensee does not notify Cytocom of its desire to receive a particular technology transfer within the time period therefor, then Cytocom will be under no obligation to make such technology transfer. The know-how transferred to Licensee pursuant to the terms of the Development Supply Agreementthis Section 5.5 shall be sufficient to enable Licensee to manufacture API, NTX Product, NTX/M▇▇▇ Product and M▇▇▇ Product, as soon as reasonably practicableapplicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Knowat commercial-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activitiesscale quantities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam Cytocom shall have no obligations further obligation to transfer any other know-how under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCothis Agreement.

Appears in 1 contract

Sources: License Agreement (Immune Therapeutics, Inc.)

Technology Transfer. Subject A. In addition to the terms granting of the Development Supply Agreementaforesaid licenses under the Technology, as soon as reasonably practicableupon Effective Date of this Agreement and the payment of the portion of the License Fee described in Paragraph III.A. above Tessera will transfer to Licensee, but in no event not later than the fifth thirty (5th30) anniversary of days from the Effective Date, Alnylam shall initiate a technology transfer to MedCocertain of the Technology, or to its Third Party manufacturer(s) of Licensed Productincluding certain TCC package specifications, selected by MedCo Standards and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful certain Technical Information for the Manufacture TCC packages licensed herein. B. Tessera will make available on at least a semiannual basis, improvements which have been reduced to practice including changes and modifications in Standards, methods, materials and specifications during the term of this Agreement through Tessera’s regularly published Technical Briefing Bulletin or substantially equivalent method. Notwithstanding the foregoing, Tessera is under no obligation to transfer and/or license any information whether confidential, proprietary or otherwise that it may be prohibited from transferring to Licensee by contract with a third party or applicable law. In the case Tessera proposes to transfer proprietary or Confidential information to Licensee, Tessera will first provide Licensee a non-confidential outline of the Licensed Productproposed Confidential information, but shall not undertake or complete any transfer unless it first receives Licensee’s written acknowledgment and approval. Notwithstanding any provision to the contrary, Tessera shall not be under any obligation to transfer or disclose actual patent applications or related documents to Licensee. C. For a period of up to twelve (12) months commencing with the Effective Date of this Agreement, and shall according to a mutually agreeable time schedule and manpower assignment schedule, Tessera will make certain of its engineering staff available at its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expenseSan ▇▇▇▇ facilities for transfer activities, including joint activities with Licensee’s engineers, as may be necessary in accordance with mutual agreement of the Costs reasonably parties to successfully complete the Technology transfer; provided, Tessera shall provide up to sixty (60) working man days of engineering support during first twelve month period for such transfer activity. If at the end of such transfer activity, Licensee has a good faith belief that more training is needed in certain technical areas, Licensee shall specifically define such technical areas to Tessera in writing and Tessera shall then provide up to an additional thirty (30) working man-days of engineering support for the Licensee defined technical areas during first twelve month period for such transfer activity. Licensee agrees to pay all reasonable coach class air travel and hotel charges incurred by Alnylam Tessera personnel in connection with such technology transfer activitiesengineering support performed at any of Licensee’s facilities outside of San ▇▇▇▇. MedCo Additional engineering interactions, conducted to collaborate on technical issues of mutual concern, shall reimburse Alnylam such Costs incurred with respect be supported by each party at its own expense. D. Additional engineering support (not to such Manufacturing technology transfer within exceed sixty (60) working days) beyond the initial twelve month period for an additional twelve (12) month period may be made available, according to a mutually agreeable time schedule and manpower assignment schedule, at a per diem rate of US $[***] days after receipt of an invoice therefor. Alnylam per support engineer, plus reasonable air travel and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCohotel charges.

Appears in 1 contract

Sources: Tcc® License Agreement (Tessera Technologies Inc)

Technology Transfer. Subject A. In addition to the terms granting of the Development Supply Agreementaforesaid licenses under the Technology, as soon as reasonably practicableupon Effective Date of this Agreement and the payment of the portion of the License Fee described in Paragraph III.A. above Tessera will transfer to Licensee, but in no event not later than the fifth thirty (5th30) anniversary of days from the Effective Date, Alnylam shall initiate a technology transfer to MedCocertain of the Technology, or to its Third Party manufacturer(s) of Licensed Productincluding certain TCC package specifications, selected by MedCo Standards and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful certain Technical Information for the Manufacture TCC packages licensed herein. B. Tessera will make available on at least a semiannual basis, improvements which have been reduced to practice including changes and modifications in Standards, methods, materials and specifications during the term of this Agreement through Tessera’s regularly published Technical Briefing Bulletin or substantially equivalent method. Notwithstanding the foregoing, Tessera is under no obligation to transfer and/or license any information whether confidential, proprietary or otherwise that it may be prohibited from transferring to Licensee by contract with a third party or applicable law. In the case Tessera proposes to transfer proprietary or Confidential information to Licensee, Tessera will first provide Licensee a non-confidential outline of the Licensed Productproposed Confidential information, but shall not undertake or complete any transfer unless it first receives Licensee’s written acknowledgment and approval. Notwithstanding any provision to the contrary, Tessera shall not be under any obligation to transfer or disclose actual patent applications or related documents to Licensee. C. For a period of up to twelve (12) months commencing with the Effective Date of this Agreement, and shall according to a mutually agreeable time schedule and manpower assignment schedule, Tessera will make certain of its engineering staff available at its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expenseSan ▇▇▇▇ facilities for transfer activities, including joint activities with Licensee’s engineers, as may be necessary in accordance with mutual agreement of the Costs reasonably parties to successfully complete the Technology transfer; provided, Tessera shall provide up to sixty (60) working man days of engineering support during first twelve month period for such transfer activity. If at the end of such transfer activity, Licensee has a good faith belief that more training is needed in certain technical areas, Licensee shall specifically define such technical areas to Tessera in writing and Tessera shall then provide up to an additional thirty (30) working man-days of engineering support for the Licensee defined technical areas during first twelve month period for such transfer activity. Licensee agrees to pay all reasonable coach class air travel and hotel charges incurred by Alnylam Tessera personnel in connection with such technology transfer activitiesengineering support performed at any of Licensee’s facilities outside of San ▇▇▇▇. MedCo Additional engineering interactions, conducted to collaborate on technical issues of mutual concern, shall reimburse Alnylam such Costs incurred with respect be supported by each party at its own expense. D. Additional engineering support (not to such Manufacturing technology transfer within exceed sixty (60) working days) beyond the initial twelve month period for an additional twelve (12) month period may be made available, according to a mutually agreeable time schedule and manpower assignment schedule, at a per diem rate of US $[***] days after receipt of an invoice thereforper support engineer, plus reasonable air travel and hotel charges. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to Any support or other services required thereafter may be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related provided upon terms mutually agreeable to the manufacture parties. E. Tessera represents that the Technical Information provided hereunder will be prepared with reasonable care and warrants that the Technical Information will, where applicable for similar types of Licensed Products. Such assignment shall TCC or related IC packages, be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all same as the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCoTechnical Information used by Tessera.

Appears in 1 contract

Sources: TCC License Agreement (Tessera Technologies Inc)