Common use of CMC Information; Drug Master File Clause in Contracts

CMC Information; Drug Master File. (a) Alexza shall be responsible for compiling the required chemistry, manufacturing, and controls information pertaining to the Product (“CMC”) and shall promptly provide such information at Teva’s request to allow Teva to obtain and maintain Regulatory Approvals in the U.S. or to communicate with FDA in the U.S. about the Product. [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (b) Alexza shall be permitted, without further approval or authorization from Teva, to continue its process and CMC improvements in effect or in place as of the Effective Date, including capacity improvements by Suppliers. Subject to the foregoing sentence, Alexza shall not, without the prior written consent of Teva, make any changes to the CMC (including any changes to the CMC included in a DMF) that would require [ * ] or other [ * ] in the U.S., or require the [ * ] or [ * ] in the U.S., or have [ * ] on [ * ] hereunder, including any changes which would [ * ] or other [ * ] of [ * ]; provided that, if Alexza provides Teva with any such proposed changes, and if Teva has not (i) responded to such changes or (ii) acknowledged the receipt of the proposed change within [ * ] Business Days and indicated that the expected response date shall be within a [ * ] Business Day period after such acknowledgement, then Teva shall be deemed to have consented to such changes. If Teva believes that a response is not practicable within such [ * ]-Business Day period, Teva shall notify Alexza in writing within such [ * ]-Business Day period of Teva’s belief, and the Parties shall then promptly discuss and agree upon the timing for review of such proposed change. For all other changes to the CMC (the “Non-NDA Changes”), Alexza shall promptly notify Teva and such changes shall be governed by the procedures to be adopted by the Manufacturing JPT and the Quality Agreement. For clarity, in the event that any NDA or Non-NDA Change is made in accordance with this Section 6.4(b), then Teva shall use Commercially Reasonable Efforts to complete and file any documentation requested by Alexza or required to be filed with the FDA as soon as practicable. (c) In the event a change in the CMC is requested or required by the FDA, or any other Regulatory Authority that could result in a change by the requirements of the FDA, Alexza shall, at its expense and subject to Section 6.18(a) amend the CMC and provide to Teva a draft of the corresponding amendment to the CMC in the format reasonably requested by Teva and provide all necessary technical assistance and services to Teva for Teva to obtain all Regulatory Approvals of such amendment to the CMC as soon as practicable. (d) If a change in the CMC is requested by Teva and such change is not requested or required by the FDA, Alexza shall in good faith make such change (unless such change would materially impact the cost or regulatory or commercial status of the Product outside the Field or U.S.) and Teva shall bear any and all of the costs and expenses resulting from any such change requested or required by Teva pursuant to this Section 6.4(d). Teva shall take all necessary or appropriate actions agreed upon by the Parties to seek the Regulatory Approval of such CMC modifications and shall be responsible for related communication with the FDA; provided that Alexza shall provide all necessary actions to assist Teva in obtaining such Regulatory Approval as soon as practicable, including preparing the draft amendment to the CMC section and participating in Teva’s communications with the FDA. (e) Alexza may, at its option and expense and to the extent permitted by law, file and maintain a drug or device master file in the U.S. containing CMC information for the Product (or a component thereof) (a “DMF” or “Drug Master File”), which shall be owned by Alexza; provided that Alexza shall make available complete and accurate copy of CMC information to Teva in the format reasonably requested by Teva for Teva to obtain and maintain its Regulatory Approval for the Product in the U.S., and shall provide technical assistance and associated services that are reasonably necessary to enable Teva to obtain and maintain its Regulatory Approval for the Product in the Field in the U.S. Teva shall have a letter of authorization to access those portions of the DMF relating to the Product for Teva to prepare the CMC information for the Product or to fully exercise its rights under this Agreement. [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

CMC Information; Drug Master File. (a) Alexza shall be responsible for compiling the required chemistry, manufacturing, and controls information pertaining to the Product (“CMC”) and shall promptly provide such information at Teva’s request to BLS to allow Teva BLS to obtain and maintain Regulatory Marketing Approvals in the U.S. Territory or to communicate with FDA in the U.S. Regulatory Authorities about the Product. (b) Alexza shall not, without the prior written consent of BLS, make any changes to the CMC (including any changes to CMC included in a DMF) that would require changes to the [ * ] or other [ * ] in the Territory or require the [ * ] of [ * ] or [ * ] in the Territory; provided that, if Alexza provides BLS with any such proposed changes, and if BLS has not (i) responded to such changes or (ii) acknowledged the receipt of the proposed change within a [ * ] and indicated the expected response date which shall be within a [ * ] period after such acknowledgement, then [ * ]. If BLS believes that a response is not practicable within such [ * ] period, then the Parties shall promptly discuss and agree upon the timing for review of such [ * ] = Certain confidential information contained in this document, marked by brackets, is has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (b) Alexza shall be permitted, without further approval or authorization from Teva, to continue its process and CMC improvements in effect or in place as of the Effective Date, including capacity improvements by Suppliers. Subject to the foregoing sentence, Alexza shall not, without the prior written consent of Teva, make any changes to the CMC (including any changes to the CMC included in a DMF) that would require [ * ] or other [ * ] in the U.S., or require the [ * ] or [ * ] in the U.S., or have [ * ] on [ * ] hereunder, including any changes which would [ * ] or other [ * ] of [ * ]; provided that, if Alexza provides Teva with any such proposed changes, and if Teva has not (i) responded to such changes or (ii) acknowledged the receipt of the proposed change within [ * ] Business Days and indicated that the expected response date shall be within a [ * ] Business Day period after such acknowledgement, then Teva shall be deemed to have consented to such changes. If Teva believes that a response is not practicable within such [ * ]-Business Day period, Teva shall notify Alexza in writing within such [ * ]-Business Day period of Teva’s belief, and the Parties shall then promptly discuss and agree upon the timing for review of such proposed change. For all other changes to the CMC (the “Non-NDA Changes”), Alexza shall promptly notify Teva and such changes shall be governed by the procedures to be adopted by the Manufacturing JPT and the Quality Agreement. For clarity, in the event that any NDA or Non-NDA Change is made in accordance with this Section 6.4(b), then Teva shall use Commercially Reasonable Efforts to complete and file any documentation requested by Alexza or required to be filed with the FDA as soon as practicable. (c) In the event a change in the CMC is requested or required by the FDA, or any other Regulatory Authority that could result FDA in a change by the requirements of the FDAU.S., Alexza shall, at its expense [ * ] and subject to Section 6.18(a3.12(a) amend the CMC and provide to Teva BLS a draft of the corresponding amendment to the CMC in the format reasonably requested by Teva BLS and provide all necessary technical assistance and services to Teva BLS for Teva BLS to obtain all Regulatory Approvals regulatory approvals of such amendment to the CMC as soon as practicable. (d) If a change in the CMC is requested by Teva and such change is not requested or required by the FDA, Alexza shall in good faith make such change (unless such change would materially impact the cost or regulatory or commercial status of the Product outside the Field or U.S.) and Teva shall bear any and all of the costs and expenses resulting from any such change requested or required by Teva pursuant to this Section 6.4(d). Teva shall take all necessary or appropriate actions agreed upon by the Parties to seek the Regulatory Approval of such CMC modifications and shall be responsible for related communication with the FDA; provided that Alexza shall provide all necessary actions to assist Teva in obtaining such Regulatory Approval as soon as practicable, including preparing the draft amendment to the CMC section and participating in Teva’s communications with the FDA. (e) Alexza may, at its option and expense and to the extent permitted by law, file and maintain a drug or device master file in the U.S. containing CMC information for the Product (or a component thereof) (a “DMF” or “Drug Master File”), which shall be owned by Alexza; provided that Alexza shall make available complete and accurate copy of CMC information to Teva in the format reasonably requested by Teva for Teva to obtain and maintain its Regulatory Approval for the Product in the U.S., and shall provide technical assistance and associated services that are reasonably necessary to enable Teva to obtain and maintain its Regulatory Approval for the Product in the Field in the U.S. Teva shall have a letter of authorization to access those portions of the DMF relating to the Product for Teva to prepare the CMC information for the Product or to fully exercise its rights under this Agreement. [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

CMC Information; Drug Master File. (a) Alexza shall be responsible for compiling the required chemistry, manufacturing, and controls information pertaining to the Product (“CMC”) and shall promptly provide such information at Teva’s request to BLS to allow Teva BLS to obtain and maintain Regulatory Marketing Approvals in the U.S. Territory or to communicate with FDA in the U.S. Regulatory Authorities about the Product. [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (b) Alexza shall be permitted, without further approval or authorization from Teva, to continue its process and CMC improvements in effect or in place as of the Effective Date, including capacity improvements by Suppliers. Subject to the foregoing sentence, Alexza shall not, without the prior written consent of TevaBLS, make any changes to the CMC (including any changes to the CMC included in a DMF) that would require changes to the [ * ] or other [ * ] in the U.S., Territory or require the [ * ] of [ * ] or [ * ] in the U.S., or have [ * ] on [ * ] hereunder, including any changes which would [ * ] or other [ * ] of [ * ]Territory; provided that, if Alexza provides Teva BLS with any such proposed changes, and if Teva BLS has not (i) responded to such changes or (ii) acknowledged the receipt of the proposed change within a [ * ] Business Days and indicated that the expected response date which shall be within a [ * ] Business Day period after such acknowledgement, then Teva shall be deemed to have consented to such changes[ * ]. If Teva BLS believes that a response is not practicable within such [ * ]-Business Day ] period, Teva shall notify Alexza in writing within such [ * ]-Business Day period of Teva’s belief, and then the Parties shall then promptly discuss and agree upon the timing for review of such [ * ] = 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 24b-2 of the Securities Exchange Act of 1934, as amended. proposed change. For all other changes to the CMC (the “Non-NDA [ * ] Changes”), Alexza shall promptly notify Teva BLS and such changes shall be governed by the procedures to be adopted by the Manufacturing JPT MS Coordination Committee and the Quality Agreement. For clarity, in the event that any NDA [ * ] or Non-NDA [ * ] Change is made in accordance with this Section 6.4(b3.3(b), then Teva BLS shall use Commercially Reasonable Efforts to complete and file any documentation requested by Alexza or required to be filed with the FDA applicable Regulatory Authority in the Territory as soon as practicable. (c) In the event a change in the CMC is requested or required by the FDA, or any other Regulatory Authority that could result FDA in a change by the requirements of the FDAU.S., Alexza shall, at its expense [ * ] and subject to Section 6.18(a3.12(a) amend the CMC and provide to Teva BLS a draft of the corresponding amendment to the CMC in the format reasonably requested by Teva BLS and provide all necessary technical assistance and services to Teva BLS for Teva BLS to obtain all Regulatory Approvals regulatory approvals of such amendment to the CMC as soon as practicable. (d) If a change in the CMC is requested by Teva BLS and such change is not requested or required by FDA or other Regulatory Authority in the FDATerritory, Alexza shall in good faith make such change (unless such change would materially impact the cost or regulatory or commercial status of the Product outside of the Field or U.S.Territory) and Teva [ * ] shall bear any and all of the costs and expenses resulting from any such change requested or required by Teva BLS pursuant to this Section 6.4(d3.3(d), including [ * ], if applicable. Teva BLS shall take all necessary or appropriate actions agreed upon by the Parties to seek the Regulatory Approval regulatory approval of such CMC modifications and shall be responsible for related communication with the FDA; provided that Alexza shall provide all necessary actions to assist Teva BLS in obtaining such Regulatory Approval regulatory approval as soon as practicable, including preparing the draft amendment to the CMC section and participating in Teva’s BLS’ communications with the FDA. (e) Alexza may, at its option and expense and to the extent permitted by law, file and maintain a drug or device master file in the U.S. containing CMC information for the Product (or a component thereof) (a “DMF” or “Drug Master File”), which shall be owned by AlexzaAlexza (a “DMF”); provided that Alexza shall make available complete and accurate copy of CMC information to Teva BLS in the format reasonably requested by Teva BLS for Teva BLS to obtain and maintain its Regulatory Marketing Approval for the Product in the U.S.Field for the Territory, and shall provide technical assistance and associated services that are reasonably necessary [ * ] to enable Teva BLS to obtain and maintain its Regulatory Marketing Approval for the Product in the Field in for the U.S. Teva Territory. BLS and its designated Third Party Manufacturers shall have a letter of authorization to access those portions of the DMF relating to the Product for Teva BLS to prepare the CMC information for the Product or to fully exercise its rights under this Agreement, including the Manufacturing right in accordance with Section 5.4 or Section 5.5. [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities Alexza shall be responsible for ensuring that all DMFs are current and Exchange Commission pursuant up to Rule 24b-2 of the Securities Exchange Act of 1934, as amendeddate.