Transfer of Licensed Know-How. Subject to the timing and obligations of the Parties with respect to the transfer of documents and information contemplated by Article 5 (including with respect to the CSR, the Safety Database Transfer, the Clinical Database, the Existing INDs, the transfer of Third Party agreements, and as provided in the Transition Plan, the Pharmacovigilance Agreement or the Quality Assurance Agreement), Novartis shall transfer to Pharming or its designee, on the timetable set forth on Exhibit B-1, a copy (in electronic format if available in electronic format, or hard copy if not available in electronic format) of the documentation and other Know-How listed on Exhibit B-2 (the “Manufacturing Technology”) and Exhibit B-3, in each case, to the extent such documentation or other Know-How is in the possession and Control of Novartis or its Affiliates as of the Effective Date after the use of Commercially Reasonable Efforts to investigate the records of Novartis and its Affiliates (it being understood that Novartis will have the right to exclude or redact any information relating to compounds or programs that are not within the scope of the license granted under Section 2.1). To the extent reasonably requested by Pharming and mutually agreed by the Transition Committee, Novartis will provide to Pharming, at Pharming’s cost, copies (in electronic format if available in electronic format, or hard copy if not available in electronic format) of such other documents embodying Licensed Know-How in the possession and Control of Novartis or its Affiliates that are reasonably necessary for the Development or Commercialization of the Licensed Compound or Licensed Product; provided, that any request for the transfer of local or country-level data must be submitted not later than three (3) months after the Effective Date. The Parties acknowledge that the transfer by Novartis of such Licensed Know-How will consist of the transfer of data residing in Novartis’ databases, and will not include the transfer of any database architecture. All documentation within the Licensed Know-How will be provided in the language such documentation was generated and will not be translated. Notwithstanding anything else in this Agreement to the contrary, the Parties acknowledge that Novartis shall have no obligation to transfer clinical samples or take any action inconsistent with or that would require any amendment or modification to a Site Agreement or a clinical study subject’s informed consent; provided, that the Parties will cooperate and endeavor in good faith to ensure that all Licensed Know-How (including clinical data) necessary for the Development, manufacture or Commercialization of the Licensed Compound and Licensed Products can be lawfully transferred to Pharming or its designee.
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Samples: License Agreement, License Agreement (Pharming Group N.V.)
Transfer of Licensed Know-How. Subject to the timing and obligations of the Parties with respect to the transfer of documents and information contemplated by Article 5 (including with respect to the CSR, the Safety Database Transfer, the Clinical Database, the Existing INDs, the transfer of Third Party agreements, and as provided in the Transition Plan, the Pharmacovigilance Agreement or the Quality Assurance Agreement), Novartis shall transfer to Pharming or its designeeErasca, on the timetable set forth on in Part 1 of Exhibit B-1E, a copy (in electronic format if it is available in electronic format, format or a hard copy if it is not available in electronic format) of the documentation and other all Licensed Know-How listed on Exhibit B-2 (the “Manufacturing Technology”) and Exhibit B-3, in each case, to the extent such documentation or other Know-How is in the possession and or Control of Novartis or its Affiliates as of the Effective Date after the use of Commercially Reasonable Efforts to investigate the records of Novartis Novartis’ and its Affiliates Affiliates’ records (it being understood that Novartis will have the right to exclude or redact any information relating to compounds or programs that are not within the scope of the license granted under Section 2.1Novartis Proprietary Compounds). To the extent reasonably requested by Pharming and mutually agreed by the Transition Committee, Novartis will provide to Pharming, at Pharming’s costincluding all IND-enabling reports, copies of all Regulatory Filings, pre-clinical reports (in electronic format if available in electronic formatincluding toxicology, or hard copy if not available in electronic formatCMC, and pharmacology) of such other documents embodying Licensed Know-How in the possession and Control of Novartis or its Affiliates that are reasonably necessary for the Development or Commercialization of relating to the Licensed Compound or and/or Licensed ProductProducts, all investigator brochures, and Clinical Trial protocols; provided, however, that any request for the transfer avoidance of local doubt, no sponsorship of INDs or country-level data must CTAs related to the Licensed Compound will be submitted not later than three (3) months after transferred in connection with this Agreement. Novartis shall provide Erasca with [***] written notice prior to closing any IND or CTA related to the Licensed Compound that is active as of the Effective Date. .
5.4.1 The timing and nature of transfer of pharmacovigilance data from the safety database shall be agreed upon separately by the Parties.
5.4.2 The Parties acknowledge that the transfer by Novartis of such Licensed Know-How that exists in electronic format will consist of the transfer of data residing in Novartis’ databases, and will not include the transfer of any database architecture, and that the foregoing will not require any experimental work to be performed by Novartis for the purpose of technology transfer.
5.4.3 [***]. All documentation within Upon the Licensed Know-How reasonable request of Xxxxxx, Novartis will use Commercially Reasonable Efforts to investigate Novartis’ and its Affiliates’ records for any requested laboratory notebooks and/or raw data and, to the extent identified by Novartis following such investigation, transfer (at Xxxxxx’s sole cost and expense, including reimbursement of external costs and Novartis’ internal personnel at a rate of [***] such laboratory notebooks and/or raw data (or copies thereof) to Erasca (it being understood that Novartis will have the right to exclude or redact any information relating to Novartis Proprietary Compounds). To the extent that any laboratory notebooks or raw data are transferred by Novartis, such notebooks and raw data may be used by Erasca for reformatting and internal analysis, and in no event will be provided submitted as part of any Regulatory Filing, unless approved in the language writing by Novartis, such documentation was generated and will approval not to be translated. Notwithstanding anything else unreasonably delayed, conditioned, or withheld.
5.4.4 Except as set forth in this Agreement Section 5.13(c), to the contraryextent a Regulatory Authority requires additional data for purposes of regulatory review to support Regulatory Approval of Licensed Products, the Parties acknowledge that Novartis shall have no obligation agrees to transfer clinical samples or take any action inconsistent with or that would require any amendment or modification to a Site Agreement or a clinical study subject’s informed consent; provided, that the Parties will cooperate and endeavor in good faith to ensure that provide such requested data to the extent Controlled by Novartis, at [***]sole cost and expense (including reimbursement of external costs and Novartis’ internal personnel at a rate of [***].
5.4.5 With respect to the Ongoing Clinical Trials, Novartis shall provide to Erasca final clinical study reports in respect of the Ongoing Clinical Trials on the estimated timelines set forth in Part 1 of Exhibit E. Novartis shall also provide to Erasca all Licensed data from investigational brochure updates and primary clinical study reports, and any other reports and summaries, from the Ongoing Clinical Trials promptly after it is generated by or on behalf of, and/or made available to, Novartis.
5.4.6 Know-How (including clinical data) necessary for in the Developmentform of tangible biospecimens, manufacture if any, will be transferred subject to applicable informed consent forms.
5.4.7 In the event that information solely concerning Novartis Proprietary Compounds or Commercialization of concerning Novartis Proprietary Compounds other than in combinations with the Licensed Compound and or Licensed Products can be lawfully is inadvertently transferred to Pharming Erasca, (a) Erasca will notify Novartis of its receipt of such information, (b) Erasca will maintain such information as Novartis Confidential Information (as set forth in Article 8) and will not use such Confidential Information for any purpose, and (c) at Erasca will, at Novartis’ election, return such information or delete such information from its designeerecords, and Xxxxxx’s Alliance Manager will provide written confirmation of such deletion.
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Transfer of Licensed Know-How. Subject (a) The Parties will work together to make available the timing Licensed Know-How required for the clinical research and obligations Development of the Licensed Products that is listed in Schedule III as promptly as reasonably possible after the Effective Date but no later than ninety (90) days after the Effective Date by [**]. Licensed Know-How developed under the Services Agreement will be transferred under the Services Agreement. The Parties with respect to the transfer of documents and information contemplated by Article 5 (including with respect to the CSR, the Safety Database Transfer, the Clinical Database, the Existing INDs, the transfer of Third Party agreements, and as provided shall discuss in the Transition Plan, the Pharmacovigilance Agreement or the Quality Assurance Agreement), Novartis shall transfer to Pharming or its designee, on the timetable set forth on Exhibit B-1, a copy (in electronic format if available in electronic format, or hard copy if not available in electronic format) of the documentation and other good faith what Licensed Know-How listed on Exhibit B-2 (in Schedule III or transferred under the “Manufacturing Technology”) and Exhibit B-3Services Agreement needs to be translated in English. NeuroBo shall hire a Third Party upon written consent by Dong-A, in each casewhich written consent shall not be unreasonably withheld, to translate such Licensed Know-How into English and any reasonable out-of-pocket costs to such Third Party for the translation services, which have been pre-approved by Dxxx-X in writing, will be split evenly between Dong-A and NeuroBo.
(b) To the extent such documentation or that any other Licensed Know-How is in required for the possession filings required for the clinical research and Control of Novartis or its Affiliates as Development of the Effective Date after Licensed Products, including the use of Commercially Reasonable Efforts to investigate the records of Novartis and its Affiliates (it being understood that Novartis will have the right to exclude or redact any information relating to compounds or programs that are not within the scope filing of the license granted under Section 2.1). To IND application and the extent reasonably requested by Pharming NDA, NeuroBo shall provide written notice to Dong-A identifying with specificity additional Licensed Know-How that is required for the filings required for clinical research and mutually agreed by the Transition Committee, Novartis will provide to Pharming, at Pharming’s cost, copies (Parties shall discuss in electronic format if available in electronic format, or hard copy if not available in electronic format) good faith augmenting the list of such other documents embodying Licensed Know-How in the possession and Control of Novartis or its Affiliates that are reasonably necessary for the Development or Commercialization of the Licensed Compound or Licensed Product; provided, that any request for the transfer of local or country-level data must be submitted not later than three (3) months after the Effective DateSchedule III. The Parties acknowledge that the transfer by Novartis of such will work together in good faith to add any additional Licensed Know-How that may be mutually agreed upon by the Parties to Schedule III and make available as promptly as reasonable thereafter any such additional Licensed Know-How that is added to Schedule III.
(c) Dong-A will consist use commercially reasonable efforts to discuss any updates to its activities with respect to the Licensed Products in the Republic of Korea in the transfer of data residing in Novartis’ databases, and will not include JDC to the transfer of extent [**]. NeuroBo can then reasonably request any database architecture. All documentation within material updates to the Licensed Know-How will be provided with specificity based on Dong-A’s updates in the language such documentation was generated and will not be translatedJDC if NeuroBo reasonably believes that [**]. Notwithstanding anything else in this Agreement to the contrary, the Parties acknowledge that Novartis shall have no obligation to transfer clinical samples or take any action inconsistent with or that would require any amendment or modification to a Site Agreement or a clinical study subject’s informed consent; provided, that the The Parties will cooperate and endeavor work together in good faith to ensure make available any such material updates to the Licensed Know-How that may be mutually agreed upon by the Parties.
(d) For the avoidance of any doubt, all Licensed Know-How provided by Dong-A hereunder is and shall remain the sole property of Dong-A and shall be deemed to be the Confidential Information of Dong-A (including clinical datasubject to Section 14, whether or not marked as such) necessary and shall not be used by NeuroBo for the Developmentany purpose other than to research, Develop, manufacture or Commercialization of (solely to the extent permitted under Section 5), use, offer to sell, sell, sublicense, and otherwise Commercialize the Licensed Compound and Licensed Products can be lawfully transferred pursuant to Pharming or its designeethis Agreement.
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