Common use of Additional Legal Compliance Clause in Contracts

Additional Legal Compliance. (i) To the best of its knowledge, Alexza and its Affiliates and any outsourcing company and contract research organization to which Alexza or its Affiliates have subcontracted activities in connection with the Drug, Staccato Device and Product (the “Contractors”) have complied with all Applicable Laws, permits, governmental licenses, registrations, approvals, concessions, franchises, authorizations, orders, injunctions and decrees in the research, development, manufacture, use and import of the Drug, Product and Staccato Device, and neither Alexza nor any of its Affiliates or its Contractors has received any written notice from any governmental authority claiming that any such activities as conducted by them are not in such compliance. [ * ] = 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. (ii) No governmental authority has commenced or, to the best of its knowledge, threatened to initiate any action to enjoin production of the Drug, Staccato Device or Product at any facility, nor has Alexza or any of its Affiliates or, to the best of its knowledge, any of its Contractors, received any notice to such effect since January 1, 2005. (iii) All development activities conducted by Alexza and its Affiliates and Contractors relating to the Drug, Product and/or Staccato Device have been conducted in compliance with all GCPs, GLPs and GMPs when applicable. (iv) To the best of its knowledge, no employee or agent of Alexza or any of its Affiliates or Contractors has made an untrue statement of a material fact to any governmental authority with respect to the Drug, Product and/or Staccato Device (whether in any Regulatory Filings or otherwise), or failed to disclose a material fact to any governmental authority required to be disclosed with respect to the Drug, Product and/or Staccato Device. (v) Alexza has made available to Teva a true and complete copy of (A) all submissions associated with the Product NDA, (B) all correspondence with FDA regarding the Product NDA, and (C) all minutes of meetings and telephone conferences with FDA with respect to the Product NDA or the Product. (vi) To the best of its knowledge and except as separately disclosed to Teva in writing, Alexza is not aware of any Patent which discloses the concept of delivering loxapine into the lungs, wherein said Patent was (a) filed prior to May 13, 2002, and (b) Controlled by a Third Party at the time of filing. Except as expressly disclosed in the prosecution of an Alexza Patent existing as of the Effective Date, to the best of its knowledge, Alexza is not aware of any publication which discloses the concept of delivering loxapine into the lungs, wherein said publication became publicly available prior to May 13, 2002. (vii) To the best of its knowledge, all of Alexza’s employees and consultants and all contract research organizations with whom Alexza has contracted to perform any activities on Alexza’s behalf in connection with Alexza’s development of the Product have assigned to Alexza all of their rights in any Patents arising from the performance of such activities. (viii) Alexza is not aware of any material fact that would lead a reasonable person to believe that Alexza will not fulfill its manufacturing obligations under this Agreement.

Additional Legal Compliance. (i) To the best of its knowledgeto AcelRx’s Best Knowledge, Alexza AcelRx and its Affiliates and any outsourcing company and contract research organization to which Alexza AcelRx or its Affiliates have subcontracted activities in connection with the Drug, Staccato Device and the Licensed Product (the “Contractors”) have complied with all Applicable Laws, permits, governmental licenses, registrations, approvals, concessions, franchises, authorizations, orders, injunctions and decrees in the research, development, manufacture, Manufacture and use and import of the Drug, Licensed Product and Staccato Device, and neither Alexza AcelRx nor any of its Affiliates or its Contractors has received any written notice from any governmental authority claiming that any such activities as conducted by them are not in such compliance. (ii) no governmental authority (including the FDA) has commenced or, to AcelRx’s Best Knowledge, threatened to initiate any action to enjoin production of the Device or the Licensed Product at any facility, nor has AcelRx or any of its Affiliates or, to the Best Knowledge of AcelRx, any of its Contractors, received any notice to such effect. [ * ] = 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. (ii) No governmental authority has commenced or, to the best of its knowledge, threatened to initiate any action to enjoin production of the Drug, Staccato Device or Product at any facility, nor has Alexza or any of its Affiliates or, to the best of its knowledge, any of its Contractors, received any notice to such effect since January 1, 2005. (iii) All all development activities conducted by Alexza AcelRx and its Affiliates and Contractors relating to the Drug, Licensed Product and/or Staccato Device have been conducted in compliance with all Applicable Laws, including all GCPs, GLPs and GMPs when applicable. (iv) To the best of its knowledgeto AcelRx’s Best Knowledge, no employee or agent of Alexza AcelRx or any of its Affiliates or Contractors has made an untrue statement of a material fact to any governmental authority with respect to the Drug, Licensed Product and/or Staccato Device (whether in any Regulatory Filings or otherwise), or failed to disclose a material fact to any governmental authority required to be disclosed with respect to the Drug, Licensed Product and/or Staccato Device. (v) Alexza To AcelRx’s Best Knowledge, AcelRx has made available disclosed or otherwise provided Grünenthal with all information that would have, or would be reasonably likely to Teva have, a true material effect on the ability of Grünenthal to develop or commercialize the Licensed Product in the Field in the Territory under the terms and complete copy conditions of this Agreement and that relates to (A) all submissions associated with the Product NDAAcelRx Technology, (B) all correspondence with FDA regarding any Third Party intellectual property rights or claims that relate to the commercialization or development of the Licensed Product NDAin the Territory, and (C) all minutes the safety or efficacy of meetings and telephone conferences with FDA with respect to the Product NDA Device or the Licensed Product. (vi) To the best of its knowledge and except as separately disclosed to Teva in writing, Alexza is not aware of any Patent which discloses the concept of delivering loxapine into the lungs, wherein said Patent was (a) filed prior to May 13, 2002, and (b) Controlled by a Third Party at the time of filing. Except as expressly disclosed in the prosecution of an Alexza Patent existing as of the Effective Date, to the best of its knowledge, Alexza is not aware of any publication which discloses the concept of delivering loxapine into the lungs, wherein said publication became publicly available prior to May 13, 2002. (vii) To the best of its knowledge, all of Alexza’s employees and consultants and all contract research organizations with whom Alexza has contracted to perform any activities on Alexza’s behalf in connection with Alexza’s development of the Product have assigned to Alexza all of their rights in any Patents arising from the performance of such activities. (viii) Alexza is not aware of any material fact that would lead a reasonable person to believe that Alexza will not fulfill its manufacturing obligations under this Agreement.

Additional Legal Compliance. (i) To As of the best of its knowledgeEffective Date, Alexza ACADIA and its Affiliates and and, to the Best Knowledge of ACADIA, any outsourcing company and contract research organization to which Alexza ACADIA or its Affiliates have subcontracted activities in connection with the Drug, Staccato Device and Product Pimavanserin (the “Contractors”) have complied in all material respects with all Applicable Laws, including all GCPs, GLPs and GMPs, permits, governmental licenses, registrations, approvals, concessions, franchises, authorizations, orders, injunctions and decrees decrees, in the research, development, manufacture, manufacture and use and import of the Drug, Product and Staccato DevicePimavanserin, and neither Alexza ACADIA nor any of its Affiliates or nor, to the Best Knowledge of ACADIA, its Contractors Contractors, has received any written notice from any governmental authority claiming that any such activities as conducted by them are not in such compliance. [ * ] = 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.47. ***Confidential Treatment Requested (ii) No governmental authority (including the FDA) has commenced or, to the best of its knowledgeACADIA’s Best Knowledge, threatened to initiate any action to enjoin production of the Drug, Staccato Device or Product Pimavanserin at any facility, nor has Alexza ACADIA or any of its Affiliates or, to the best Best Knowledge of its knowledgeACADIA, any of its Contractors, received any notice to such effect since January 1, 2005[…***…]. (iii) All development activities conducted by Alexza and its Affiliates and Contractors relating to the Drug, Product and/or Staccato Device have been conducted in compliance with all GCPs, GLPs and GMPs when applicable. (iv) To the best of its knowledge, no employee or agent of Alexza or any of its Affiliates or Contractors has made an untrue statement of a material fact to any governmental authority with respect to the Drug, Product and/or Staccato Device (whether in any Regulatory Filings or otherwise), or failed to disclose a material fact to any governmental authority required to be disclosed with respect to the Drug, Product and/or Staccato Device. (v) Alexza ACADIA has made available to Teva BLS a true and correct copy, which is complete copy in all material respects, of (Ai) all IND submissions associated with the Product NDAPimavanserin, (Bii) all data from clinical studies conducted under the IND, (iii) all material correspondence with FDA Regulatory Authorities regarding the Product NDAIND, and (Civ) all minutes of meetings and telephone conferences with FDA Regulatory Authorities with respect to the Product NDA IND or the ProductPimavanserin. […***…]. (vi) To the best of its knowledge and except as separately disclosed to Teva in writing, Alexza is not aware of any Patent which discloses the concept of delivering loxapine into the lungs, wherein said Patent was (a) filed prior to May 13, 2002, and (b) Controlled by a Third Party at the time of filing. Except as expressly disclosed in the prosecution of an Alexza Patent existing as of the Effective Date, to the best of its knowledge, Alexza is not aware of any publication which discloses the concept of delivering loxapine into the lungs, wherein said publication became publicly available prior to May 13, 2002. (vii) To the best of its knowledge, all of Alexza’s employees and consultants and all contract research organizations with whom Alexza has contracted to perform any activities on Alexza’s behalf in connection with Alexza’s development of the Product have assigned to Alexza all of their rights in any Patents arising from the performance of such activities. (viii) Alexza is not aware of any material fact that would lead a reasonable person to believe that Alexza will not fulfill its manufacturing obligations under this Agreement.

Additional Legal Compliance. (i) To to the best of its knowledge, Alexza and its Affiliates and any outsourcing company and contract research organization to which Alexza or its Affiliates have subcontracted activities in connection with the Drug, Staccato Device and Product (the “Contractors”) have complied with all Applicable Laws, permits, governmental licenses, registrations, approvals, concessions, franchises, authorizations, orders, injunctions and decrees in the research, development, manufacture, manufacture and use and import of the Drug, Product and Staccato DeviceProduct, and neither Alexza nor any of its Affiliates or its Contractors has received any written notice from any governmental authority claiming that any such activities as conducted by them are not in such compliance. [ * ] = 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. (ii) No no governmental authority has commenced or, to the best of its knowledge, threatened to initiate any action to enjoin production of the Drug, Staccato Device or Product at any facility, nor has Alexza or any of its Affiliates or, to the best of its knowledge, any of its Contractors, received any notice to such effect since January 1, 2005. (iii) All all development activities conducted by Alexza and its Affiliates and Contractors relating to the Drug, Product and/or Staccato Device have been conducted in compliance with all GCPs, GLPs and GMPs when applicable. (iv) To to the best of its knowledge, no employee or agent of Alexza or any of its Affiliates or Contractors has made an untrue statement of a material fact to any governmental authority with respect to the Drug, Product and/or Staccato Device (whether in any Regulatory Filings or otherwise), or failed to disclose a material fact to any governmental authority required to be disclosed with respect to the Drug, Product and/or Staccato DeviceProduct. (v) Alexza has made available to Teva Xxxxxx a true true, correct and complete copy of (A) all submissions associated with the Product Existing NDA, (B) all correspondence with FDA Regulatory Authorities regarding the Product Existing NDA, and (C) all minutes of meetings and telephone conferences with FDA Regulatory Authorities with respect to the Product Existing NDA or the Product. (vi) To the best of its knowledge and except as separately disclosed to Teva in writing, Alexza is not aware of any Patent which discloses the concept of delivering loxapine into the lungs, wherein said Patent was (a) filed prior to May 13, 2002, and (b) Controlled by a Third Party at the time of filing. Except as expressly disclosed in the prosecution of an Alexza Patent existing as of the Effective Date, to the best of its knowledge, Alexza is not aware of any publication which discloses the concept of delivering loxapine into the lungs, wherein said publication became publicly available prior to May 13, 2002. (vii) To the best of its knowledge, all of Alexza’s employees and consultants and all contract research organizations with whom Alexza has contracted to perform any activities on Alexza’s behalf in connection with Alexza’s development of the Product have assigned to Alexza all of their rights in any Patents arising from the performance of such activities. (viii) Alexza is not aware of any material fact that would lead a reasonable person to believe that Alexza will not fulfill its manufacturing obligations under this Agreement.

Additional Legal Compliance. (i) To the best of its knowledgeAlexza’s Best Knowledge, Alexza and its Affiliates and any outsourcing company and contract research organization to which Alexza or its Affiliates have subcontracted activities in connection with the Drug, Staccato Device and the Product (the “Contractors”) have complied with all Applicable Laws, permits, governmental licenses, registrations, approvals, concessions, franchises, authorizations, orders, injunctions and decrees in the research, development, manufacture, manufacture and use and import of the DrugProduct, Product and Staccato Devicethe Device or any component thereof, and neither Alexza nor any of its Affiliates or its Contractors has received any written notice from any governmental authority Regulatory Authority claiming that any such activities as conducted by them are not in such compliance. . (ii) No governmental authority (including the FDA) has commenced or, to Alexza’s Best Knowledge, threatened to initiate any action to enjoin production of the Device, the Product or any component thereof at any facility, nor has Alexza or any of its [ * ] = 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. (ii) No governmental authority has commenced or, to the best of its knowledge, threatened to initiate any action to enjoin production of the Drug, Staccato Device or Product at any facility, nor has Alexza or any of its . Affiliates or, to the best Best Knowledge of its knowledgeAlexza, any of its Contractors, received any notice to such effect since January 1, 2005. (iii) All development activities conducted by Alexza and its Affiliates and to Alexza’s Best Knowledge Contractors relating to the DrugProduct, Product the Device and/or Staccato Device any component thereof have been conducted in compliance with all GCPsApplicable Laws, GLPs including without limitation all GCP, GLP and GMPs GMP when applicable. (iv) To the best of its knowledgeAlexza’s Best Knowledge, no employee or agent of Alexza or any of its Affiliates or Contractors has made an untrue statement of a material fact to any governmental authority Regulatory Authority with respect to the DrugProduct, Product the Device and/or Staccato Device any component thereof (whether in any Regulatory Filings or otherwise), or failed to disclose a material fact to any governmental authority Regulatory Authority required to be disclosed with respect to the DrugProduct, Product the Device and/or Staccato Deviceany component thereof. (v) Alexza has made available to Teva BLS a true true, correct and complete copy of (A) all IND and NDA submissions associated with the Product NDAProduct, (B) all correspondence with FDA Regulatory Authorities regarding the Product IND or NDA, (C) all clinical studies included in IND and NDA for the Product, and (CD) all minutes of meetings and telephone conferences with FDA Regulatory Authorities with respect to the Product IND, NDA or the Product. (vi) To the best of its knowledge and except as separately disclosed to Teva in writingAlexza’s Best Knowledge, Alexza is not aware has disclosed or otherwise provided BLS with all information that would have, or would be reasonably likely to have, a material effect on the ability of BLS to develop or commercialize Product in the Field in the Territory under the terms and conditions of this Agreement and that relates to (A) the Alexza Technology, (B) any Patent which discloses Third Party intellectual property rights or claims that relate to the concept commercialization or development of delivering loxapine into Product in the lungsTerritory, wherein said Patent was (aC) filed prior to May 13, 2002, the safety or efficacy of the Device or Product and (bD) Controlled by the ability of a Third Party at company with reasonable manufacturing capability to manufacture the time of filing. Except as expressly disclosed in Device, the prosecution of an Alexza Patent existing as Product or any component thereof, assuming the completion of the Effective Date, transfer of the Alexza Know-How related to the best of its knowledge, Alexza is not aware of any publication which discloses the concept of delivering loxapine into the lungs, wherein said publication became publicly available prior to May 13, 2002. (vii) To the best of its knowledge, all of Alexza’s employees and consultants and all contract research organizations with whom Alexza has contracted to perform any activities on Alexza’s behalf in connection with Alexza’s development manufacturing of the Product have assigned to Alexza all of their rights such company in any Patents arising from accordance with the performance of such activities. (viii) Alexza is not aware of any material fact that would lead a reasonable person to believe that Alexza will not fulfill its manufacturing obligations under this Supply Agreement.