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 3.1 WAKUNAGA shall transfer as promptly after the Effective Date as possible to MELINTA on an “as is” basis (i) complete copies of all of its files relating to the terms Wakunaga Patents, (ii) copies of written documentation relating to 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 Wakunaga Proprietary Information that is reasonably necessary or useful for MELINTA to perform its obligations or exercise its rights under this Agreement, and, to the Manufacture extent that Abbott transfers same to WAKUNAGA with the right to disclose to MELINTA, (iii) copies of all files relating to the Abbott Patents, and (iv) copies of all Abbott Proprietary Information received pursuant to the Termination Agreement. 3.2 WAKUNAGA shall, to the extent within the scope of the Licensed ProductWakunaga Patents, and Wakunaga Proprietary Information, Abbott Patents and/or Abbott Proprietary Information, provide MELINTA with technical support during the term of this Agreement under the conditions set forth in this Section 3.2. WAKUNAGA personnel shall make available its personnel on a reasonable basis not be required to consult with MedCo provide MELINTA or such Third Party manufacturer(sany Sublicensee of MELINTA in excess of ten (10) 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 days of support with respect to such Manufacturing technology transfer within the subject matter of this Agreement which may occur at any time following the Effective Date. In the event that, subject to WAKUNAGA’s prior consent after negotiation between the Parties, which consent shall not be unreasonably withheld, WAKUNAGA will provide support in excess of ten (10) days of support, MELINTA hereby agrees to pay or have MELINTA Sublicensee pay WAKUNAGA at the rate of [***] days after receipt (or such other reasonable rate as notified by WAKUNAGA upon thirty (30) days’ prior written notice) for time spent by WAKUNAGA personnel in connection with any support services requested by MELINTA or any MELINTA Sublicensee. WAKUNAGA personnel for the foregoing technical support may include up to forty (40) hours of an invoice therefor. Alnylam time of AbbVie personnel at WAKUNAGA’s sole discretion, or such other amount as agreed by AbbVie, and its Affiliates all such personnel shall keep complete sign reasonable and accurate records in sufficient detail to enable customary confidentiality agreements as reasonably agreed by 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.Parties. 3.3 WAKUNAGA shall, Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts reasonable efforts to assign cause AbbVie to, take all commercially reasonable steps necessary to MedCo any manufacturing agreement between Alnylam provide declarations, consents 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 agreementsignatures, including any as well as perform all other activities reasonably 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 transfer of Proprietary Information as per Sections 3.1 and 3.2 above. The Parties recognize that WAKUNAGA cannot assure MELINTA that AbbVie will comply with all 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 MedCorequests.

Appears in 2 contracts

Sources: License Agreement (Melinta Therapeutics, Inc. /New/), License Agreement (Melinta Therapeutics, Inc. /New/)

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 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 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)

Technology Transfer. Subject to the terms of After the Development Supply AgreementTransfer Date, Lpath shall use Commercially Reasonable Efforts to promptly transfer to Merck as soon as reasonably practicablepractical, 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 all Lpath Know-How How, including any preclinical data, clinical data, assays and associated materials, protocols, procedures and any other information in Lpath’s possession or control, that is reasonably necessary or useful for to continue or initiate Development of, or in seeking Regulatory Approval for, Licensed Products. For clarity, Lpath shall at all times have the Manufacture right to retain reasonable quantities of the Licensed Producttangible materials (if any) within such Lpath Know-How, and shall make available its personnel on a reasonable basis may use them, and authorize others to consult with MedCo or such Third Party manufacturer(s) with respect theretouse them, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activitiesOcular Products or other products outside the Field. 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 Merck shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam cooperate and a Third Party that is solely related to facilitate such transfer, and 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 Parties shall use Commercially Reasonable Efforts to obtain any complete such consent transfer within *** after the Development Transfer Date. Details shall be set forth in a form reasonably acceptable technology transfer plan to MedCobe agreed upon by the Parties (“Technology Transfer Plan”) which plan shall set forth agreed-upon steps for an adequate technology transfer and timelines therefore, an outline of which is attached to this Agreement as Schedule 3.7. In addition, and without limiting the generality of the foregoing, upon Merck’s request Lpath shall (i) promptly assign to Merck all applications and filings made with any Regulatory Authority solely applicable to the Development or Commercialization of Licensed Products in and for the Field (and not applicable to any Ocular Product or other product outside the Field), including any applicable IND and orphan drug designations with respect thereto, (ii) use ***CONFIDENTIAL PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. Commercially Reasonable Efforts to assign to Merck all agreements related solely to the conduct of any Clinical Trial in and for the Field with respect to Licensed Product and to seek any required Third Party consents therefor (provided that such Commercially Reasonable Efforts shall not require Lpath to make payments or provide other consideration to any Third Party in consideration therewith), and (iii) assign to Merck all agreements, if any, related solely to the manufacture, supply or distribution of clinical supplies of Licensed Product for Clinical Trials in the Field (to the extent such agreement is specific to Clinical Trials in the Field, and not related to Ocular Products or other products outside the Field). For clarity, notwithstanding the foregoing, Lpath shall have the right to retain, and shall not be required to assign to Merck, (A) any applications and filings made with any Regulatory Authority related to Ocular Products (including IND number 100786), (B) any agreements which relate to clinical trials of Ocular Products, or (C) any agreement related to the manufacture, supply or distribution of, or which otherwise relate to, Ocular Products or other products outside the Field.

Appears in 1 contract

Sources: License Agreement (Lpath, Inc)

Technology Transfer. Subject to Under the terms of the Development Commercial Supply Agreement, as soon as reasonably practicableGSK will have the right, but in no event later than the fifth (5th) anniversary at its election, to receive technology transfer from Gilead of the Effective Date, Alnylam shall initiate manufacturing processes for bulk ADV and Licensed Products used by Gilead's Third-Party suppliers [ * ] if GSK makes an election to manufacture either bulk ADV or finished Licensed Product either for China or for the GSK Territory as a technology transfer whole as provided herein. GSK may elect to MedCo, or to its Third Party manufacturer(s) of manufacture either bulk ADV and finished Licensed Product, selected by MedCo and reasonably acceptable to Alnylamor finished Licensed Product alone, 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 each case with respect to China alone, and also with respect to the entire GSK Territory (less China, if GSK made such Manufacturing election for China prior to making such election for the entire GSK Territory). For an initial transfer of manufacturing processes as to which GSK has not elected to assume responsibility in the GSK Territory previously, GSK shall give at least [ * ] written notice to commence such transfer, and the Parties will complete transfer of all such relevant information to GSK within [ * ] after the date of commencement of transfer, subject to acceptance criteria as more fully set forth in the Commercial Supply Agreement. GSK shall [ * ] in relation to any such technology transfer. Such [ * ] shall comprise [ * ] Such [ * ] shall also be documented and subject to audit by GSK. For the avoidance of doubt, GSK shall remain obligated to purchase amounts of bulk ADV and Licensed Products for which it submits binding forecasts or orders pursuant to the Commercial Supply Agreement, notwithstanding any election it makes hereunder. If GSK separately exercises its right to manufacture hereunder with respect to China, and later with respect to the remainder of the GSK Territory (or vice versa), then Gilead shall only be obligated to provide GSK with technology transfer within [***of any improvements Controlled by Gilead to the manufacturing process earlier transferred to GSK that have been implemented by Gilead's Third-Party suppliers [ * ] days after receipt Similarly, if GSK separately exercises its right to manufacture hereunder with respect to bulk ADV, and later with respect to finished Licensed Products, then Gilead shall only be obligated to provide GSK with technology transfer of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail any improvements Controlled by Gilead to enable the payments payable hereunder manufacturing process earlier transferred to be determined. Alnylam GSK that have been implemented by Gilead's Third-Party suppliers [ * ] Except as expressly provided herein, Gilead shall not be required to perform provide further technology transfer to more than one Third for process changes that Gilead or its 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 MedCosuppliers develop or implement.

Appears in 1 contract

Sources: Licensing Agreement (Gilead Sciences Inc)

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 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 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 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.)