Common use of Limitations on Grant Clause in Contracts

Limitations on Grant. Backs; Transfer Expenses For purposes of clarity, irrespective of anything to the contrary in this Agreement: a) All transfers and licenses from Roche to FMI or other obligations of Roche under Section 17.3 are solely with respect to Product(s). b) In connection with clinical trials, Roche may have collected human samples and related clinical information for additional limited research and development programs (“Samples”). Legal and contractual restrictions may apply to such Samples, in particular as Samples may qualify as personal identifiable information. FMI acknowledges and accepts that notwithstanding anything herein, Roche shall not be obliged to transfer any such Samples to FMI. c) Nothing in this Agreement shall be construed as granting FMI any license under the intellectual property of Roche or its Affiliates in existence as of the Effective Date. d) Except with respect to termination by FMI for Roche’s breach pursuant to Section 17.2.2, FMI shall promptly reimburse Roche for all reasonable out-of-pocket costs and expenses (including FTE charges based on Roche’s standard FTE rates) incurred by or on behalf of Roche for transfer of documents and materials as requested by FMI under this Article 17; however transfer activities corresponding to the return of material remains, data, reports, records, documents, Regulatory Filings and Regulatory Approvals originally provided by FMI to Roche (“FMI-Originated Transfer Activities”) shall be at no expense to FMI. If FMI desires Roche Transfer Activities other than FMI-Originated Transfer Activities, FMI shall make a payment to Roche of […***…] (“Minimum Transfer Payment”). The Minimum Transfer Payment shall be non-refundable, but shall be fully creditable against FMI’s reimbursement for the Roche Transfer Activities. Roche shall be under no obligation to provide Roche Transfer Activities (beyond the FMI-Originated Transfer Activities) prior to receipt of the Minimum Transfer Payment.

Limitations on Grant. Backs; Transfer Expenses For purposes of clarity, irrespective of anything to the contrary in this Agreement: a) All transfers and licenses from Roche to FMI or other obligations of Roche under Section 17.3 are solely with respect to Product(s).. - 45 - ***Confidential Treatment Requested*** b) In connection with clinical trials, Roche may have collected human samples and related clinical information for additional limited research and development programs (“Samples”). Legal and contractual restrictions may apply to such Samples, in particular as Samples may qualify as personal identifiable information. FMI acknowledges and accepts that notwithstanding anything herein, Roche shall not be obliged to transfer any such Samples to FMI. c) Nothing in this Agreement shall be construed as granting FMI any license under the intellectual property of Roche or its Affiliates in existence as of the Effective Date. d) Except with respect to termination by FMI for Roche’s breach pursuant to Section 17.2.2, FMI shall promptly reimburse Roche for all reasonable out-of-pocket costs and expenses (including FTE charges based on Roche’s standard actual FTE ratesRates, not to exceed the FTE Rates set forth in the Collaboration Agreement) incurred by or on behalf of Roche for transfer of documents and materials as requested by FMI under this Article 1717 (“Roche Transfer Activities”); however transfer activities corresponding to the return of material remains, data, reports, records, documents, Regulatory Filings and Regulatory Approvals originally provided by FMI to Roche (“FMI-Originated Transfer Activities”) shall be at no expense to FMI. If FMI desires Roche Transfer Activities other than FMI-Originated Transfer Activities, FMI shall make a payment to Roche of […***…] (“Minimum Transfer Payment”). The Minimum Transfer Payment shall be non-refundable, but shall be fully creditable against FMI’s reimbursement for the Roche Transfer Activities. Roche shall be under no obligation to provide Roche Transfer Activities (beyond the FMI-Originated Transfer Activities) prior to receipt of the Minimum Transfer Payment.

Limitations on Grant. Backs; Transfer Expenses For purposes of clarity, irrespective of anything to the contrary in this Agreement: (a) All transfers Roche shall transfer to Regeneron all PII/Samples promptly following expiration or termination of this Agreement subject to compliance with applicable contractual restrictions, patient consents and licenses from Roche to FMI or other obligations of Roche under Section 17.3 are solely with respect to Product(s). b) In connection with clinical trials, Roche may have collected human samples and related clinical information for additional limited research and development programs (“Samples”)Applicable Law. Legal and contractual restrictions may apply to such Samples, in particular as Samples may qualify as personal identifiable information. FMI acknowledges and accepts that notwithstanding anything herein, Roche shall not be obliged obligated to transfer any an PII/Samples that Roche in good faith believes would be prohibited or would subject Roche to potential liability by reason of Applicable Law, contractual restrictions or insufficient patient consent. Upon completion of such transfers, Regeneron shall use the transferred PII/Samples for the sole purpose of developing, manufacturing and commercializing the Product(s), and Regeneron shall be responsible for the correct use of the PII/Samples in line with the informed consent forms (including but not limited to FMIpotential re-consenting of the patients at Regeneron’s costs). c(b) Nothing The costs and expenses incurred in connection with the Roche Transfer Activities shall be shared by the Parties as follows: (i) if this Agreement shall be construed as granting FMI any license under the intellectual property of Roche or its Affiliates in existence as of the Effective Date. d) Except is terminated by Regeneron pursuant to Section 19.2.1, Section 19.2.3 (or, with respect to termination by FMI for Roche’s breach a Terminated Country, pursuant to Section 17.2.219.2.2(a) or Section 19.2.2(b)), FMI Roche shall promptly be responsible for its own costs and expenses incurred for the Roche Transfer Activities, and shall reimburse Regeneron for all reasonable out-of-pocket costs and expenses incurred by or on behalf of Regeneron for the Roche Transfer Activities; (ii) if this Agreement is terminated by Roche pursuant to Section 19.2.1 or Section 19.2.3, Regeneron shall be responsible for its own costs and expenses incurred for the Roche Transfer Activities, and shall reimburse Roche for all reasonable out-of-pocket and internal costs and expenses incurred by or on behalf of Roche for the Roche Transfer Activities; (iii) if this Agreement is terminated pursuant to Section 19.2.4 or Section 19.2.5 (or, with respect to a Terminated Country, pursuant to Section 19.2.2(c)), Regeneron shall be responsible for its own costs and expenses incurred for the Roche Transfer Activities and shall reimburse Roche for all reasonable out-of-pocket costs and expenses (including FTE charges based on Roche’s standard FTE rates) incurred by or on behalf of Roche for transfer of documents and materials as requested by FMI under this Article 17the Roche Transfer Activities; however provided further that transfer activities corresponding to the return of material remains, data, reports, records, documents, Regulatory Filings regulatory filings and Regulatory Approvals originally provided by FMI Regeneron to Roche no less than three (“FMI-Originated Transfer Activities”3) years from the effective date of termination or expiration shall be at no expense returned to FMI. If FMI desires Regeneron free of charge. (c) Unless otherwise agreed to by the Parties, transfer of physical materials that are required under Roche Transfer Activities other than FMI-Originated Transfer Activities, FMI shall make a payment to Roche of […***…] (“Minimum Transfer Payment”). The Minimum Transfer Payment shall be non-refundabledelivered, but shall be fully creditable against FMIat Roche’s reimbursement for the Roche Transfer Activities. Roche shall be under no obligation to provide Roche Transfer Activities option, FCA international courier near location where materials stored at time of transfer (beyond the FMI-Originated Transfer ActivitiesIncoterms 2010) prior to receipt of the Minimum Transfer Paymentor CPT Regeneron or Regeneron’s designee (Incoterms 2010).