Common use of Regulatory Support Clause in Contracts

Regulatory Support. LTC will support HTG’s efforts to obtain Regulatory Approval before each Regulatory Authority as follows: (a) within 30 days of HTG’s written request for same, provide HTG with a letter authorizing the Regulatory Authority (i) to reference and incorporate, as appropriate, into HTG’s filings the Documentation and LTC’s Device Master Record for the LTC Instrument or LTC Software, and (ii) to reproduce, make derivatives of, and incorporate the Documentation and the Device Master Record specified in that letter in connection with preparing, submitting, and prosecuting any filings in furtherance of Regulatory Approval; (b) use commercially reasonable efforts to provide HTG with and relevant, applicable information related to LTC Instruments, LTC Software and LTC Consumables in the event such information is required by a Regulatory Authority in HTG’s submission of the HTG Assay to a Regulatory Authority; (c) use commercially reasonable efforts to provide directly to the Regulatory Authority any Documentation requested by a Regulatory Authority in connection with in HTG’s submission of the HTG Assay to a Regulatory Authority; (d) allow HTG or a Regulatory Authority to audit the relevant portion(s) of LTC’s facility(ies) where the LTC Products are manufactured, tested or stored, upon 45 days prior written notice (or such shorter period as may be required to comply with requested or ordered inspections by a Regulatory Authority), during normal business hours, no more often than one time per calendar year or more often as required of HTG by any Regulatory Authority, and at HTG’s sole expense, only to the extent necessary to satisfy HTG’s obligations under applicable law. LTC will reasonably cooperate in the conduct of any such audit. The locations, times, and dates for such audits will be mutually agreed upon in writing between the Parties before conducting the audit. HTG will comply with LTC’s reasonable requirements and directions for the conduct of the audit, including LTC’s obligation to protect its confidential information and that of its other clients. In certain cases, LTC may require that its standard confidentiality agreement is executed in advance of any such audit. LTC will maintain adequate records in accordance with applicable law relating to the manufacture and testing of LTC Products for no less than five years from the end of the calendar quarter in which the LTC Products to which they pertain were shipped to HTG. HTG will provide a confidential written report of all findings within a mutually agreed upon time period, but in no event less than 30 days after the audit completion date or more than sixty (60) days after the audit completion date; and (e) at least […***…] months before any such change is made, use commercially reasonable efforts to provide prior written notice to HTG of any material changes to form, fit, or function or discontinuation of any LTC Product that is material to any Regulatory Approval or on which any Regulatory Approval is based (“Product Change”). If, as a result of the Product Change, HTG is required to seek an additional regulatory review of an HTG Assay, then LTC agrees to engage in good faith discussions with HTG to support HTG in obtaining additional regulatory clearance and/or approval. Notwithstanding anything in this Agreement to the contrary, if HTG must modify an HTG Assay (“Original Assay”) in response to a Product Change, whether to obtain additional regulatory clearance and/or approval or otherwise, the HTG Assay so modified shall be substituted for the Original Assay for all purposes of this Agreement, and LTC shall not be entitled to any additional milestone payments pursuant to Section 8.3 and the total number of assays available for development by HTG under this Agreement shall not be reduced.

Regulatory Support. LTC will support HTG’s efforts to obtain Regulatory Approval before each Regulatory Authority as follows: (a) within 30 days of HTG’s written request for sameCatalytica will provide ORPHAN with standard regulatory support as identified under the heading “Regulatory Support” in Appendix E attached hereto. In addition, provide HTG Catalytica shall provided ORPHAN with a letter authorizing regulatory consulting services as identified under the heading “Regulatory Authority (i) to reference and incorporateConsulting” in Appendix E attached hereto. Regulatory support services, as appropriateidentified in Appendix E, into HTGshall be at no additional charge to ORPHAN; regulatory consulting services shall be billed at Catalytica’s filings standard hourly rates and payable pursuant to Section 7.7 of this Agreement. Additional regulatory services and/or documentation may be provided by Catalytica, subject to agreement of the Documentation parties and LTC’s Device Master Record for the LTC Instrument or LTC Software, and (ii) subject to reproduce, make derivatives of, and incorporate the Documentation and the Device Master Record specified in that letter in connection with preparing, submitting, and prosecuting any filings in furtherance of Regulatory Approval;additional charges. (b) Notwithstanding the above or anything in this Agreement or Appendix E to the contrary, ORPHAN is solely responsible for (i) its use commercially reasonable efforts of any documentation provided by Catalytica, including without limitation use in any regulatory submission to provide HTG with and relevant, applicable information related to LTC Instruments, LTC Software and LTC Consumables in the event such information is required by a Regulatory Authority in HTG’s submission FDA or any other regulatory agency inside or outside of the HTG Assay to a Regulatory Authority;United States, (ii) document control and retention, (iii) determining the suitability of any documentation provided by Catalytica hereunder for use in any regulatory submission; and (iv) all regulatory submission, CMC and other regulatory strategies. (c) use commercially reasonable efforts Catalytica may, at its option, retain copies of any documentation provided to ORPHAN hereunder; provided, however, that Catalytica cannot and does not provide directly any assurances that Catalytica’s records will match or otherwise correspond to any submission that ORPHAN may provide to the Regulatory Authority FDA or any Documentation requested by a Regulatory Authority in connection with in HTG’s submission of other regulatory agency inside or outside the HTG Assay to a Regulatory Authority;United States. (d) allow HTG or a Regulatory Authority ORPHAN shall provide Catalytica with all documents reasonably requested by Catalytica relating to audit the relevant portion(sFDA’s pre-approval inspection of Catalytica’s manufacturing facility, including, but not limited to, development reports, CMC sections of ORPHAN’S NDA and stability data. In addition, ORPHAN shall provide to Catalytica at least thirty (30) of LTC’s facility(ies) where the LTC Products are manufactured, tested or stored, upon 45 days prior written notice to filing with the FDA a copy of ORPHAN’S annual report (or such shorter period as may be required to comply see 21 C.F.R. Section 314.81(b)(2)(iv)) with requested or ordered inspections by a Regulatory Authority), during normal business hours, no more often than one time per calendar year or more often as required of HTG by any Regulatory Authority, and at HTG’s sole expense, only to the extent necessary to satisfy HTG’s obligations under applicable law. LTC will reasonably cooperate in the conduct of any such audit. The locations, times, and dates for such audits will be mutually agreed upon in writing between the Parties before conducting the audit. HTG will comply with LTC’s reasonable requirements and directions for the conduct of the audit, including LTC’s obligation to protect its confidential information and that of its other clients. In certain cases, LTC may require that its standard confidentiality agreement is executed in advance of any such audit. LTC will maintain adequate records in accordance with applicable law relating respect to the manufacture and testing of LTC Products for no less than five years from the end of the calendar quarter in which the LTC Products to which they pertain were shipped to HTG. HTG will provide a confidential written report of all findings within a mutually agreed upon time period, but in no event less than 30 days after the audit completion date or more than sixty (60) days after the audit completion date; and (e) at least […***…] months before any such change is made, use commercially reasonable efforts to provide prior written notice to HTG of any material changes to form, fit, or function or discontinuation of any LTC Product that is material to any Regulatory Approval or on which any Regulatory Approval is based (“Product Change”). If, as a result control of the Product Change, HTG is required and ORPHAN shall take into consideration any Catalytica comments to seek an additional regulatory review of an HTG Assay, then LTC agrees such annual report with respect to engage in good faith discussions with HTG to support HTG in obtaining additional regulatory clearance and/or approvalthe Product. Notwithstanding the foregoing or anything in this Agreement to the contrary, if HTG must modify an HTG Assay (“Original Assay”) in response to a Product Change, whether to obtain additional regulatory clearance and/or approval or otherwise, the HTG Assay so modified ORPHAN shall be substituted solely responsible for the Original Assay for all purposes of this Agreement, and LTC shall not be entitled to any additional milestone payments pursuant to Section 8.3 and the total number of assays available for development by HTG under this Agreement shall not be reducedCMC regulatory strategy.

Regulatory Support. LTC will support HTG’s efforts to obtain Regulatory Approval before each Regulatory Authority as follows: (a) within 30 days of HTG’s written request for sameCatalytica will provide ORPHAN with standard regulatory support as identified under the heading “Regulatory Support” in Appendix E attached hereto. In addition, provide HTG Catalytica shall provided ORPHAN with a letter authorizing regulatory consulting services as identified under the heading “Regulatory Authority (i) to reference and incorporateConsulting” in Appendix E attached hereto. Regulatory support services, as appropriateidentified in Appendix E, into HTGshall be at no additional charge to ORPHAN; regulatory consulting services shall be billed at Catalytica’s filings standard hourly rates and payable pursuant to Section 7.7 of this Agreement. Additional regulatory services and/or documentation may be provided by Catalytica, subject to agreement of the Documentation parties and LTC’s Device Master Record for the LTC Instrument or LTC Software, and (ii) subject to reproduce, make derivatives of, and incorporate the Documentation and the Device Master Record specified in that letter in connection with preparing, submitting, and prosecuting any filings in furtherance of Regulatory Approval;additional charges. (b) Notwithstanding the above or anything in this Agreement or Appendix E to the contrary, ORPHAN is solely responsible for (i) its use commercially reasonable efforts of any documentation provided by Catalytica, including without limitation use in any regulatory submission to provide HTG with and relevant, applicable information related to LTC Instruments, LTC Software and LTC Consumables in the event such information is required by a Regulatory Authority in HTG’s submission FDA or any other regulatory agency inside or outside of the HTG Assay to a Regulatory Authority;United States, (ii) document control and retention, (iii) determining the suitability of any documentation provided by Catalytica hereunder for use in any regulatory submission; and (iv) all regulatory submission, CMC and other regulatory strategies. (c) use commercially reasonable efforts Catalytica may, at its option, retain copies of any documentation [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. provided to ORPHAN hereunder; provided, however, that Catalytica cannot and does not provide directly any assurances that Catalytica’s records will match or otherwise correspond to any submission that ORPHAN may provide to the Regulatory Authority FDA or any Documentation requested by a Regulatory Authority in connection with in HTG’s submission of other regulatory agency inside or outside the HTG Assay to a Regulatory Authority;United States. (d) allow HTG or a Regulatory Authority ORPHAN shall provide Catalytica with all documents reasonably requested by Catalytica relating to audit the relevant portion(sFDA’s pre-approval inspection of Catalytica’s manufacturing facility, including, but not limited to, development reports, CMC sections of ORPHAN’S NDA and stability data. In addition, ORPHAN shall provide to Catalytica at least thirty (30) of LTC’s facility(ies) where the LTC Products are manufactured, tested or stored, upon 45 days prior written notice to filing with the FDA a copy of ORPHAN’S annual report (or such shorter period as may be required to comply see 21 C.F.R. Section 314.81(b)(2)(iv)) with requested or ordered inspections by a Regulatory Authority), during normal business hours, no more often than one time per calendar year or more often as required of HTG by any Regulatory Authority, and at HTG’s sole expense, only to the extent necessary to satisfy HTG’s obligations under applicable law. LTC will reasonably cooperate in the conduct of any such audit. The locations, times, and dates for such audits will be mutually agreed upon in writing between the Parties before conducting the audit. HTG will comply with LTC’s reasonable requirements and directions for the conduct of the audit, including LTC’s obligation to protect its confidential information and that of its other clients. In certain cases, LTC may require that its standard confidentiality agreement is executed in advance of any such audit. LTC will maintain adequate records in accordance with applicable law relating respect to the manufacture and testing of LTC Products for no less than five years from the end of the calendar quarter in which the LTC Products to which they pertain were shipped to HTG. HTG will provide a confidential written report of all findings within a mutually agreed upon time period, but in no event less than 30 days after the audit completion date or more than sixty (60) days after the audit completion date; and (e) at least […***…] months before any such change is made, use commercially reasonable efforts to provide prior written notice to HTG of any material changes to form, fit, or function or discontinuation of any LTC Product that is material to any Regulatory Approval or on which any Regulatory Approval is based (“Product Change”). If, as a result control of the Product Change, HTG is required to seek an additional regulatory review of an HTG Assay, then LTC agrees to engage in good faith discussions with HTG to support HTG in obtaining additional regulatory clearance and/or approval[ * ]. Notwithstanding the foregoing or anything in this Agreement to the contrary, if HTG must modify an HTG Assay (“Original Assay”) in response to a Product Change, whether to obtain additional regulatory clearance and/or approval or otherwise, the HTG Assay so modified ORPHAN shall be substituted solely responsible for the Original Assay for all purposes of this Agreement, and LTC shall not be entitled to any additional milestone payments pursuant to Section 8.3 and the total number of assays available for development by HTG under this Agreement shall not be reducedCMC regulatory strategy.

Regulatory Support. LTC will support HTG’s efforts to obtain Regulatory Approval before each Regulatory Authority as follows: (a) within 30 days of HTG’s written request for same, provide HTG with a letter authorizing the Regulatory Authority (i) POLYPEPTIDE agrees to reference and incorporate, as appropriate, into HTG’s filings the Documentation and LTC’s Device Master Record for the LTC Instrument or LTC Software, and (ii) to reproduce, make derivatives of, and incorporate the Documentation and the Device Master Record specified in that letter in connection with preparing, submitting, and prosecuting any filings in furtherance of Regulatory Approval; (b) use commercially reasonable efforts to provide HTG assist CUSTOMER, in seeking approval of its NDA(s) with respect to PRODUCT. In furtherance of (and relevantwithout limiting) the foregoing, applicable information related POLPYPEPTIDE agrees to LTC Instruments, LTC Software and LTC Consumables in the event such information is required by a Regulatory Authority in HTG’s submission of the HTG Assay to a Regulatory Authority; (c) use commercially reasonable efforts to provide directly address feedback from the FDA (whether provided to POLYPEPTIDE or CUSTOMER) regarding the comparability of registration batches of PRODUCT manufactured by POLYPEPTIDE (before or after the Effective Date) that are submitted to the Regulatory Authority any Documentation requested by a Regulatory Authority FDA in connection with the NDA filing for the PRODUCT. (b) POLYPEPTIDE agrees to cooperate with any inspection by the FDA or other Regulatory Authority, including, but not limited to any inspection prior to approval of a PRODUCT NDA. (c) POLYPEPTIDE agrees to (i) establish and maintain a separate DMF for each manufacturing site for the PRODUCT in HTGaccordance with POLYPEPTIDE’s submission SOP and the requirements of applicable Regulatory Authorities; and (ii) provide [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. CUSTOMER and their respective licensees in the Territory, with letters of access to, and rights to reference, each such DMF and any other comparable files. POLYPEPTIDE shall obtain CUSTOMER’S prior written approval of the HTG Assay to a Regulatory Authority;Specifications filed in any DMF. (d) allow HTG or At CUSTOMER’s request, POLYPEPTIDE agrees to provide such documentation and data as CUSTOMER reasonably requires to complete and maintain the CMC section of CUSTOMER’s NDA filings, in addition to, the filing and maintenance of the DMFs. POLYPEPTIDE shall establish each DMF in a timely manner to support CUSTOMER’s NDA filings, and shall provide to CUSTOMER such documentation, data and other information relating to the PRODUCT as CUSTOMER may require for submission to Regulatory Authority Authorities. (e) POLYPEPTIDE agrees to audit the relevant portion(s) provide CUSTOMER with written copies of LTC’s facility(ies) where the LTC Products are manufactured, tested or stored, upon 45 any proposed changes to a DMF at least [**] days prior to filing the changes, which changes shall not be implemented without CUSTOMER’s written notice (or such shorter period as may be consent except to the extent required to comply with requested or ordered inspections by the requirements of a Regulatory Authority), during normal business hours, no more often than one time per calendar year or more often as required of HTG by any Regulatory Authority, Authority which are indentified to CUSTOMER and at HTG’s sole expense, only to the extent necessary to satisfy HTG’s obligations under applicable law. LTC will reasonably cooperate implemented in the conduct of any such audit. The locations, times, and dates for such audits will be mutually agreed upon in writing between the Parties before conducting the audit. HTG will comply with LTC’s reasonable requirements and directions for the conduct of the audit, including LTC’s obligation to protect its confidential information and that of its other clients. In certain cases, LTC may require that its standard confidentiality agreement is executed in advance of any such audit. LTC will maintain adequate records in accordance with applicable law relating to the manufacture and testing of LTC Products for no less than five years from the end of the calendar quarter in which the LTC Products to which they pertain were shipped to HTG. HTG will provide a confidential written report of all findings within a mutually agreed upon time period, but in no event less than 30 days after the audit completion date or more than sixty (60) days after the audit completion date; and (e) at least […***…] months before any such change is made, use commercially reasonable efforts to provide prior written notice to HTG of any material changes to form, fit, or function or discontinuation of any LTC Product that is material to any Regulatory Approval or on which any Regulatory Approval is based (“Product Change”). If, as a result of the Product Change, HTG is required to seek an additional regulatory review of an HTG Assay, then LTC agrees to engage in good faith discussions with HTG to support HTG in obtaining additional regulatory clearance and/or approval. Notwithstanding anything in this Agreement to the contrary, if HTG must modify an HTG Assay (“Original Assay”) in response to a Product Change, whether to obtain additional regulatory clearance and/or approval or otherwise, the HTG Assay so modified shall be substituted for the Original Assay for all purposes of this Agreement, and LTC shall not be entitled to any additional milestone payments pursuant to Section 8.3 and the total number of assays available for development by HTG under this Agreement shall not be reducedmanner.