Licensee must deliver to Licensor within ​ after the end of each Calendar Quarter after the First Commercial Sale of a Licensed Product a report setting forth the calculation of the royalties due to Licensor for such Calendar Quarter on a Licensed Product by Licensed Product basis, including:

Records and Reports. [[Savara:Organization]] shall maintain complete, current and accurate records of # all work conducted by it, its Affiliates or sublicensees under the Development Plan or any Additional Development Plan; # all data, Know-How and Patents resulting from such work; and # all Development Costs incurred in connection therewith (collectively, the “Development Records”). Within ten (10) days of the end of each calendar quarter during the Term, [[Savara:Organization]] shall provide [[Grifols:Organization]] with written reports, in a form to be reasonably approved by [[Grifols:Organization]], detailing all Development Records for such calendar quarter; provided, that [[Grifols:Organization]] may request up to two (2) additional Development Records from [[Savara:Organization]] and [[Savara:Organization]] shall produce such Development Records in any calendar year. The Parties shall review all such reports on a quarterly basis.

Records, Reports and Information. Each Party shall maintain complete, current and accurate records of all work conducted by it under each Development Plan, and all Data resulting from such work. Such records shall fully and properly reflect all work done and results achieved in the performance of such Development Plan in good scientific manner appropriate for regulatory purposes. Each Party shall document all preclinical studies, non-clinical studies and Clinical Studies in formal written study reports according to applicable national and international guidelines (e.g., ICH, GCP, GLP and GMP). Each Party shall have the right to review such records maintained by the other Party at reasonable times, upon written request, which shall not exceed once a year unless such request for review is required by # Applicable Laws or # its voluntary CAPA initiative. Each Party shall present reports in English at the JSC meetings on its Development and regulatory activities with respect to the Products, including any significant formal or informal meetings between such Party and the Regulatory Authorities in its respective Territory, at a level of detail to be agreed by the JSC; provided, however, that any such presentation shall include at least a summary of the resulting Data for all preclinical studies, non-clinical studies and all Clinical Studies conducted by such Party with the Product, subject to [[Forty Seven:Organization]]’s obligations to its licensees and the Upstream Agreements.

Development Records and Reports. Each Party shall maintain or cause to be maintained complete and accurate records (in the form of technical notebooks and/or electronic files where appropriate) of all work conducted by it or on its behalf under the Development Plan and all Information resulting from such work. Such records, including any electronic files where such Information may also be contained, shall fully and properly reflect all work done and results achieved in the performance of the Development Plan in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. Such records shall be retained by such Party for at least five (5) years after the term of this Agreement or such longer period as may be required by applicable laws. Each Party shall have the right to review and copy such records maintained by the other Party at reasonable times and to obtain access to originals to the extent needed for patent or regulatory purposes or for other legal proceedings. Each Party shall provide the China Committee with quarterly reports detailing its Development activities under the Development Plan and the results of such activities.

Records and Reports. Each Party shall prepare and maintain, or shall cause to be prepared and maintained, in conformity with standard pharmaceutical and biotechnology industry practices and the terms and conditions of this Agreement, complete and accurate written records, accounts, notes, reports and data with respect to all Development activities with respect to Product. Such records shall fully and properly reflect, in good scientific manner appropriate for regulatory and patent purposes, all work done and results achieved in the performance of all Development activities for Product, both in and outside the Licensed Field, in the Territory. Each Party shall document all non-clinical studies and clinical trials in formal written study records, and shall document all manufacturing activities for Products, in each case in accordance with Applicable Laws, including applicable national and international guidelines such as ICH, GCP, GLP and GMP. The Parties shall discuss the status, progress and results of all Development activities with respect to Product, both in and outside the Licensed Field, in the Territory at such JSC meetings.

Records and Reports Requirements. All plans and specifications maintained by Tenant in connection with the Building Systems, and any warranties and guaranties and operating manuals relating to the Building Systems (collectively, the "Building Systems Documents") shall be maintained by Tenant throughout the Lease Term and delivered to Landlord upon the expiration or earlier termination of the Lease Term or any termination of Tenant's management of the Building Systems under this Article 7 or this Lease, to the extent not previously delivered to Landlord on an as-is basis, without representation or warranty, Landlord acknowledges that such materials may not be assignable or to be relied on by Landlord pursuant to their terms.

Eagle shall keep accurate and complete records, consistent with pharmaceutical industry standards, of each Detail and its obligations hereunder in connection therewith. Such records shall be kept for the longer of # five (5) years after the end of the Fiscal Year to which they relate and # such period of time as required by Applicable Laws. Within 15 days following the end of each Fiscal Quarter during the Term, Eagle shall provide TYME with a written report (each a “Detail Report”), setting out # the quarterly average number of Sales Representatives during such Fiscal Quarter (calculated by taking the sum of the number of Sales Representatives employed by Eagle (or its affiliates) that have incentive compensation packages that comply with the terms of Section 4.1.4 on each Business Day of the Fiscal Quarter divided by the number of Business Days in such Fiscal Quarter) (the “Quarterly Average Sales Force Size”), # the aggregate actual number of Details for the Product made by its Sales Representatives during such Fiscal Quarter, # the aggregate number of Exclusive Details, # the aggregate number of Multidisciplinary Details, # the number of Primary Multidisciplinary Details, and # the number of Details broken down by the name of the Target Professionals and such professional’s Specialty. Through the SOC, the Parties shall agree on a mutually acceptable form of Detail Report.

Reports and Records. The Company has Made Available all environmental audits and environmental assessments and any other documents identifying environmental, health or safety liabilities of the Company.

Records and Reports. [[Savara:Organization]] shall maintain, in accordance with its normal and customary practices, records of all work conducted by it, its Affiliates or sublicensees regarding the Commercialization of Licensed Products (the “Commercialization Records”). [[Savara:Organization]] shall provide written reports on its Commercialization of the Licensed Product, in a form reasonably acceptable to [[Grifols:Organization]], detailing all Commercialization work conducted by it, its Affiliates or sublicensees during the previous calendar quarter, in which case such Commercialization Records shall be delivered to [[Grifols:Organization]] on a calendar quarter basis; provided, that [[Grifols:Organization]] may request two (2) additional such reports from [[Savara:Organization]] during any calendar year.

Commencing with the first meeting of the JDT and continuing until delivery of the TLF to Licensee pursuant to [Section 4.1.2], Relay will prepare and deliver to the JDT, written reports summarizing its Development activities performed to date by Relay (or updating such report for activities performed since the last such report submitted hereunder, as applicable) with respect to the Relay Phase Ia Trial (including if # prior to the transfer to Licensee of the safety database for the Relay Phase Ia Trial, a # dose-limiting toxicity (“DLT”) or # serious adverse event (“SAE”), in each case ((i) and (ii)) that is related to or could reasonably be related to the Licensed Candidate or Licensed Product, is observed or # following the transfer to Licensee of the safety database for the Relay Phase Ia Trial any DLT or SAE is observed in the Relay Phase Ia Trial) at least ​ prior to each scheduled JDT meeting. Relay will further report to the JDT (and for the period prior to the formation of the JDT, directly to Licensee) # prior to implementation, any contemplated amendments or material changes to the Relay Phase Ia Plan and any contemplated Development activities with respect to a Relay Pipeline Combination that could reasonably be expected to materially conflict with or negatively impact the design or conduct of any Development activities contemplated by Licensee, including pursuant to the GDP, # if a # DLT or # SAE is observed in accordance with the SAE Management Plan, or prior to execution of the SAE Management Plan, is observed and is related to or could reasonably be related to the Licensed Candidate or Licensed Product, then immediately, and in any event within ​ after observation of or becoming aware of such DLT or SAE event, # immediately (and in any event within ​) whenever Relay receives an inquiry/request for information or other Material Communication from a Regulatory Authority with respect to the Relay Phase Ia Trial, # any contemplated dose or cohort decision with respect to the Relay Phase Ia Trial prior to any such decision, and # such other data and information and summaries thereof as are agreed by the JDT in the data and information sharing plan contemplated in [Section 10.2.2(k)].