Common use of CHANGES IN SPECIFICATIONS Clause in Contracts

CHANGES IN SPECIFICATIONS. (i) Alexza may, without Teva’s approval, but in any event with notification to Teva, change the Specifications to reflect any changes currently in process as of the Effective Date. Thereafter, Alexza may request a change in the Specifications; provided that, Alexza shall not make any changes to the Specifications without Teva’s prior written approval, which approval shall not be unreasonably withheld or delayed. In the event that such proposed change requires the [ * ] of the [ * ], the Parties shall coordinate and collaborate in [ * ] and Alexza shall not implement any such change unless and until [ * ] is [ * ]. Notwithstanding the foregoing, if any change to the Specification requested by Alexza would not require any change to the Product NDA or any Regulatory Approvals in the U.S. or require the submission of a Regulatory Approval application supplement in the U.S., Alexza shall promptly notify Teva of such change through the Manufacturing JPT. [ * ] shall be solely responsible for all costs (including both implementation and [ * ] costs and expenses) incurred in connection with any changes requested by Alexza, except to the extent otherwise agreed by the Parties. (ii) Each Party shall promptly notify the other Party of any change of the Specifications that is required by the FDA or in order to comply with any Regulatory Requirement applicable to the Product for use or sale in the Field in the U.S. Any such changes shall be implemented at Teva’s sole expense unless such Specification changes are also CMC changes and such CMC changes would apply to other APIs and not the Drug specifically, in which case, such CMC changes shall be implemented at Alexza’s sole expense. In consultation with Teva, Alexza shall, promptly make all such regulatory required changes to the Specifications and the Parties shall coordinate and collaborate in making all necessary Regulatory Filings with the FDA to effect such change. Alexza shall compile and provide to Teva the necessary information required to support any such Regulatory Filing in the format reasonably requested by Teva, and shall provide all necessary technical assistance and services to Teva. Teva shall be responsible for making such Regulatory Filing and paying filing fees required for such Regulatory Filing. [ * ] = 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.

Appears in 1 contract

Sources: License and Supply Agreement (Alexza Pharmaceuticals Inc.)

CHANGES IN SPECIFICATIONS. The Specifications may be amended by RELYPSA to comply with requirements set by Regulatory Authorities and for other reasons (i) Alexza maythe “Changes in Specifications”). LANXESS’s obligation to Manufacture Bulk Drug or Bulk Intermediate in accordance with any Changes in Specifications shall be determined in accordance with this Section 10.2, without Teva’s approvaland, but if the Changes in Specifications are effected in accordance with this Section, then the Parties will comply with the change control procedures set forth in the Quality Agreement. LANXESS may at any event with notification time propose amendments to Teva, change the Specifications to reflect any changes currently in process as of the Effective Date. Thereafter, Alexza may request a change in the Specifications; provided thatprovided, Alexza however, that LANXESS shall not make any no changes to the Specifications without TevaRELYPSA’s prior written approvalconsent in its sole reasonable discretion. Upon receipt from RELYPSA of a written request for Changes in Specifications containing suitable detail and documentation to permit LANXESS to analyze the impact of such request, which approval LANXESS shall promptly and, in any event, within [***] days (unless a longer period is agreed upon by the Parties as required due to the scope of the requested changes) (i) determine the impacts of the requested Changes in Specifications on the Manufacturing process (including [***]), (ii) provide a timeline for their implementation, and (iii) propose an increase or decrease in the Base Price for Bulk Drug incorporating the Changes in Specifications. The Parties will closely cooperate and use reasonable best efforts to agree upon and implement the requested Changes in Specifications if technically feasible and as soon as reasonably practicable provided that RELYPSA [***], and the Parties agree upon the increase or decrease in the Base Price for Bulk Drug Manufactured in accordance with Specifications incorporating the Changes in Specifications. Any Changes in Specifications that may be agreed upon by the Parties pursuant to this Section 10.2 will not be unreasonably withheld or delayed. In the event that such proposed change requires the [ * ] of the [ * ], effective until the Parties shall coordinate and collaborate in [ * ] and Alexza shall not implement any such complete the change unless and until [ * ] is [ * ]. Notwithstanding the foregoing, if any change to the Specification requested by Alexza would not require any change to the Product NDA or any Regulatory Approvals control procedure in the U.S. or require Quality Agreement to document the submission Changes in Specifications. The agreed-upon Base Price for Manufacture of a Regulatory Approval application supplement Bulk Drug incorporating the Changes in the U.S., Alexza Specifications shall promptly notify Teva of such change through the Manufacturing JPT. [ * ] shall be solely responsible reimburse LANXESS for all costs (for the implementation of such changes and the Manufacture of Bulk Intermediate and/or Bulk Drug, as applicable, in accordance with such changes, including both implementation its costs for any delay resulting from the implementation. Upon the agreement of the Parties in accordance with this Section 10.2 and [ * ] costs the change control procedure in the Quality Agreement, the Changes in Specifications will be incorporated into the then current Specifications and expenses) incurred the amended Specifications shall thereafter be Specifications for all purposes under this Agreement; provided, that no Changes in connection with any changes requested by AlexzaSpecifications shall be implemented unless the prior written approval of applicable Regulatory Authorities to the change, except if and to the extent otherwise agreed required, has been obtained. Upon LANXESS’ receipt of a written notice from RELYPSA regarding any Changes in Specifications, LANXESS shall not commence or continue to Manufacture and RELYPSA shall have no obligation to accept or pay for Bulk Drug Manufactured after receipt of such notice without RELYPSA’s prior written consent in its sole discretion, and RELYPSA shall only be required to accept Bulk Drug that conforms to amended Specifications incorporating such Changes in Specifications. Any Bulk Drug or Bulk Intermediate as to which Manufacturing is completed by LANXESS prior to receipt of such written request for Changes in Specifications and which is Released by LANXESS (and is not Nonconforming) under the Parties. (ii) Each Party shall promptly notify the other Party of any change of the prior Specifications that is required by the FDA or in order to comply accordance with any Regulatory Requirement applicable to the Product for use or sale in the Field in the U.S. Any such changes this Agreement shall be implemented at Teva’s sole expense unless such Specification changes are also CMC changes and such CMC changes would apply to other APIs and not the Drug specifically, in which case, such CMC changes shall be implemented at Alexza’s sole expense. In consultation with Teva, Alexza shall, promptly make all such regulatory required changes to the Specifications and the Parties shall coordinate and collaborate in making all necessary Regulatory Filings with the FDA to effect such change. Alexza shall compile and provide to Teva the necessary information required to support any such Regulatory Filing in the format reasonably requested paid for by Teva, and shall provide all necessary technical assistance and services to Teva. Teva shall be responsible for making such Regulatory Filing and paying filing fees required for such Regulatory Filing. [ * ] = 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 amendedRELYPSA.

Appears in 1 contract

Sources: Manufacturing and Supply Agreement (Relypsa Inc)

CHANGES IN SPECIFICATIONS. (i) Alexza may, without Teva’s approval, but in any event with notification to Teva, change the Specifications to reflect any changes currently in process as of the Effective Date. Thereafter, Alexza may request a change in the Specifications; provided that, Alexza shall not make any changes to the Specifications without Teva’s BLS’ prior written approval, which approval shall not be unreasonably withheld or delayed. In the event that such proposed change requires the [ * ] of the [ * ] or [ * ], the Parties shall coordinate and collaborate in making all necessary [ * ] and Alexza shall not implement any such change unless and until such [ * ] is [ * ]. Notwithstanding the foregoing, if any change to the Specification requested by Alexza would not require any change [ * ] to the Product NDA [ * ] or any Regulatory Approvals [ * ] in the U.S. Territory or require the submission [ * ] of a Regulatory Approval application supplement [ * ] or [ * ] in the U.S.Territory, Alexza shall promptly notify Teva BLS of such change through and such change shall be governed by the Manufacturing JPTprocedures to be adopted by the MS Coordination Committee and the Quality Agreement. [ * ] shall be solely responsible for [ * ] all costs (including both implementation and [ * ] regulatory costs and expenses) incurred in connection with any changes requested by Alexza, except to the extent otherwise agreed by the PartiesParties pursuant to Section 4.2(d). (ii) Each Party shall promptly notify the other Party of any change of the Specifications that is required by the FDA any Regulatory Authority or in order to comply with any Regulatory Requirement applicable to the Product for use or sale in the Field in the U.S. Any Territory. Prior to the receipt of the Marketing Approval of the Product for the Territory, such regulatory required Specification changes shall be implemented at Teva’s sole expense [ * ]. After the receipt of the Marketing Approval of the Product for the Territory, such regulatory required Specification changes shall be implemented at [ * ] unless (x) such Specification changes are also CMC [ * ] changes and (y) such CMC [ * ] changes would apply to other APIs [ * ] and not the Drug specifically[ * ], in which case, such CMC [ * ] changes shall be implemented at Alexza’s sole expense[ * ]. In consultation with TevaBLS, Alexza shall, promptly make all such regulatory required changes to the Specifications and the Parties shall coordinate and collaborate in making all necessary Regulatory Filings with the FDA application Regulatory Authority to effect such change. Alexza shall shall, [ * ], compile and provide to Teva BLS the necessary information required to support any such Regulatory Filing in the format reasonably requested by TevaBLS, and shall provide all necessary technical assistance and services to Teva. Teva shall be responsible for making such Regulatory Filing and paying filing fees required for such Regulatory Filing. [ * ] = 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. and services to BLS. BLS shall be responsible for making such Regulatory Filing and paying filing fees required for such Regulatory Filing.

Appears in 1 contract

Sources: Manufacture and Supply Agreement (Alexza Pharmaceuticals Inc.)

CHANGES IN SPECIFICATIONS. (i) Alexza may, without Teva’s approval, but in any event with notification to Teva, change the Specifications to reflect any changes currently in process as of the Effective Date. Thereafter, Alexza may request a change in the Specifications; provided that, Alexza shall not make any changes to the Specifications without Teva’s prior written approval, which approval shall not be unreasonably withheld or delayed. In the event that such proposed change requires the [ * ] of the [ * ], the Parties shall coordinate and collaborate in [ * ] and Alexza shall not implement any such change unless and until [ * ] is [ * ]. Notwithstanding the foregoing, if any change to the Specification requested by Alexza would not require any change to the Product NDA or any Regulatory Approvals in the U.S. or require the submission of a Regulatory Approval application supplement in the U.S., Alexza shall promptly notify Teva of such change through the Manufacturing JPT. [ * ] shall be solely responsible for all costs (including both implementation and [ * ] costs and expenses) incurred in connection with any changes requested by Alexza, except to the extent otherwise agreed by the Parties. (ii) Each Party shall promptly notify the other Party of any change of the Specifications that is required by the FDA or in order to comply with any Regulatory Requirement applicable to the Product for use or sale in the Field in the U.S. Any such changes shall be implemented at Teva’s sole expense unless such Specification changes are also CMC changes and such CMC changes would apply to other APIs and not the Drug specifically, in which case, such CMC changes shall be implemented at Alexza’s sole expense. In consultation [ * ] = 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. with Teva, Alexza shall, promptly make all such regulatory required changes to the Specifications and the Parties shall coordinate and collaborate in making all necessary Regulatory Filings with the FDA to effect such change. Alexza shall compile and provide to Teva the necessary information required to support any such Regulatory Filing in the format reasonably requested by Teva, and shall provide all necessary technical assistance and services to Teva. Teva shall be responsible for making such Regulatory Filing and paying filing fees required for such Regulatory Filing. [ * ] = 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.

Appears in 1 contract

Sources: License and Supply Agreement (Alexza Pharmaceuticals Inc.)

CHANGES IN SPECIFICATIONS. 2.1 Prior to execution of the Agreement, Servier provided XOMA with proposed Specifications for (a) Amlodipine API for the Initial Licensed Product, (b) Perindopril API for the Initial Licensed Product, and (c) the Initial Licensed Product itself. The Parties acknowledge that, promptly following the Original Agreement Effective Date, they agreed on such Specifications, and parts (a), (b) and (c), respectively, of Appendix 2.1 attached to this Schedule 6 set forth such agreed specifications. The Parties agree on the Specifications for ACEON API and ACEON itself set forth in Appendix 2.1A hereto. On request, Servier shall provide XOMA with proposed Specifications in connection with XOMA’s determination to exercise the Option for any Additional Combination Product(s). The Parties shall endeavor in good faith to agree on Specifications for the APIs and Clinical Supplies, if any, for each Additional Combination Product as to which XOMA intends to exercise the Option and shall supplement Appendix 2.1 hereto to include such additional Specifications. 2.2 If (a) at any time a Regulatory Authority requests or a change to applicable Law or guidelines requires that Servier change the Specifications, configuration, packaging and/or manufacturing processes for APIs or Clinical Supplies, as the case may be, to be supplied to XOMA hereunder, or (b) following an inspection pursuant to Section 5.5 hereof Servier must change the Specifications, configuration, packaging and/or manufacturing processes for APIs or Clinical Supplies, as the case may be, to be supplied to XOMA hereunder in order to maintain or regain compliance with Specifications, US cGMPs (in the case of API), EU cGMPs (in the case of Clinical Supplies) and/or applicable Laws or guidelines and so notifies Servier in writing, then (i) Alexza mayServier will provide XOMA with as much notice as possible of such change(s) and the Parties will consult about such change(s) and Servier will consider XOMA’s comments in good faith in connection with such change(s), without Tevaand (ii) Servier shall bear all costs and expenses associated with such change(s), unless otherwise agreed by the Parties, and will be responsible for applying for and obtaining any approvals from Regulatory Authorities necessary as a result of the proposed change(s) to continue to manufacture APIs and, as applicable, Clinical Supplies. Servier will promptly reimburse XOMA for the costs of any filings or other actions XOMA must take with any Regulatory Authority as a result of any and all such changes that relate to Licensed Products upon receipt of an invoice therefor. If such change(s) would cause a conflict between the requirements of two or more Regulatory Authorities with jurisdiction over the Licensed Products, the Parties will confer in a good-faith attempt to resolve the conflict. If despite good-faith efforts by the Parties, such conflict cannot be resolved, Servier will continue to produce APIs and/or Clinical Supplies, as the case may be, in accordance with the original unchanged Specifications, configuration, packaging and/or manufacturing process for XOMA’s use and sale in the Territory, until such time as the conflict can be resolved; so long as Servier or Servier’s contract or toll manufacturers are not prevented by applicable Law from producing APIs and/or Clinical Supplies, as the case may be, in accordance with the original Specifications, configuration, packaging and/or manufacturing processes. XOMA shall cooperate with Servier in any reasonable manner to effect any such change. Servier will disclose all information to XOMA and provide assistance to XOMA, at XOMA’s costs, as may be reasonably necessary or desirable for XOMA to complete its quality assurance testing and qualification of such changes (i.e., for manufacturing and stability) of any APIs and/or Clinical Supplies, as the case may be, supplied to XOMA. 2.3 If at any time Servier or a Servier contract or toll manufacturer wishes to change the Specifications, configuration, packaging and/or manufacturing process for APIs and/or Clinical Supplies, as the case may be, to be supplied to XOMA hereunder and such change is not requested by a Regulatory Authority or required by a change in applicable Law or guidelines, Servier will provide XOMA with at least [*] days’ prior written notice of such change(s). XOMA will consider in good faith any such request during such [*] day period. If after such analysis XOMA approves the change(s), such approval not to be unreasonably withheld or delayed, then Servier shall bear all costs and expenses associated with such change(s), unless otherwise agreed by the Parties, and will be responsible for applying for and obtaining any approvals from Regulatory Authorities necessary as a result of the proposed change(s) to continue to manufacture APIs and/or Clinical Supplies, as the case may be. Servier will promptly reimburse XOMA for the costs of any filings or other actions XOMA must take with any Regulatory Authority as a result of any and all such changes that relate to Licensed Products upon receipt of an invoice therefor. If, on the other hand, XOMA determines, that the proposed change(s) would materially hamper (a) the Development or Commercialization of a Licensed Product or (b) the effectiveness or safety of any Licensed Product for use in the Field, then Servier will continue to produce APIs and/or Clinical Supplies, as the case may be, in accordance with the original unchanged Specifications, configuration, packaging and/or manufacturing processes for XOMA’s use and sale. 2.4 Except as requested by a Regulatory Authority or required by applicable Law or guidelines, Servier shall not affect any change under Section 2.3 which (a) would require XOMA to seek approval for such change from any Regulatory Authority in order to continue the Development or Commercialization of a Licensed Product, unless Servier bears all costs and expenses associated with such approval, but or (b) would materially hamper the effectiveness or safety of any Licensed Product for use in the Field. 2.5 If at any event with notification to Teva, change the Specifications to reflect any changes currently in process as of the Effective Date. Thereafter, Alexza may request time XOMA requests a change in the Specifications; provided that, Alexza configuration, packaging and/or manufacturing processes for APIs and/or Clinical Supplies, as the case may be, to be supplied to XOMA hereunder that is not requested by a Regulatory Authority or required by a change in applicable Law or guidelines, including a change in formulation or dosage, Servier shall not make any changes consider in good faith, and shall use Diligent Efforts to the Specifications without Teva’s prior written approvalcause its Third Party subcontractors to consider in good faith, which approval shall not be unreasonably withheld or delayed. In the event that such proposed change requires the [ * ] of the [ * ], the Parties shall coordinate and collaborate in [ * ] and Alexza shall not implement any such change requests received from XOMA. If Servier approves any such change(s), such approval to be given at Servier’s sole discretion. XOMA will bear all reasonable costs incurred by Servier in effecting such change(s), unless and until [ * ] is [ * ]. Notwithstanding the foregoing, if any change to the Specification requested by Alexza would not require any change to the Product NDA or any Regulatory Approvals in the U.S. or require the submission of a Regulatory Approval application supplement in the U.S., Alexza shall promptly notify Teva of such change through the Manufacturing JPT. [ * ] shall be solely responsible for all costs (including both implementation and [ * ] costs and expenses) incurred in connection with any changes requested by Alexza, except to the extent otherwise agreed by the Parties. (ii, and all reasonable costs incurred by Servier in seeking regulatory approval necessary as a result of such change(s) Each Party shall promptly notify to continue to manufacture APIs and/or Clinical Supplies in any and all countries where Servier supplies the APIs and/or Clinical Supplies, as the case may be. XOMA will be responsible for, and will bear the costs of, any filings or other Party of any change of the Specifications that is required by the FDA or in order to comply actions it must take with any Regulatory Requirement applicable Authority as a result of such change(s) that relate to the Product for use or sale applicable Licensed Product. 2.6 Except as indicated in the Field in the U.S. Any such changes shall be implemented at Teva’s sole expense unless such Specification changes are also CMC changes and such CMC changes would apply to other APIs and not the Drug specificallySection 2.5 above, in which case, such CMC changes shall be implemented at Alexza’s sole expense. In consultation with Teva, Alexza shall, promptly make all such regulatory required changes to the Specifications and the Parties shall coordinate and collaborate in making all necessary Regulatory Filings with the FDA to effect such change. Alexza shall compile and provide to Teva the necessary information required to support any such Regulatory Filing in the format reasonably requested by Teva, and shall provide all necessary technical assistance and services to Teva. Teva Servier shall be responsible for making such applying for and obtaining any approvals from Regulatory Filing and paying filing fees required for such Regulatory Filing. [ * ] = Certain confidential information contained Authorities that may be necessary as a result of the proposed change(s) described in this document, marked by brackets, is filed with the Securities Article 2 for its manufacture and Exchange Commission pursuant to Rule 24b-2 supply of the Securities Exchange Act of 1934APIs and/or Clinical Supplies, as amendedthe case may be, to XOMA. XOMA shall be responsible for applying for and obtaining any Regulatory Approval in the Territory of any Licensed Product that may be necessary as a result of the proposed change(s) in the manufacture of any API and/or Clinical Supplies, as the case may be, to be supplied by Servier hereunder. Each Party shall use its commercially reasonable efforts to obtain such approvals as promptly as is practicable.

Appears in 1 contract

Sources: License and Commercialization Agreement (XOMA Corp)

CHANGES IN SPECIFICATIONS. (a) The Specifications may be amended by RELYPSA to comply with requirements set by Regulatory Authorities and for other reasons (the "Changes in Specifications"). Upon receipt from RELYPSA of a written request for Changes in Specifications, DSM shall promptly and, in any event, within [***] (unless a longer period is agreed upon by the Parties), (i) Alexza maydetermine the impact of the requested Changes in Specifications on the Manufacturing process (including any revalidation of analytical methods), without Teva(ii) provide a timeline for their implementation, and (iii) propose an increase or decrease in the Base Price for Ca Bulk Drug or Third Party Intermediate, if applicable, incorporating the Changes in Specifications. The Parties will closely cooperate and use reasonable best efforts to agree upon and implement the requested Changes in Specifications if the implementation in the Facility is technically feasible and as soon as reasonably practicable provided that RELYPSA agrees to the method of implementation and timeline, and the Parties agree upon the increase or decrease in the Base Price incorporating the Changes in Specifications based upon the principle that [***] in connection with the implementation of Changes in Specification. Upon the agreement of the Parties in accordance with this Section 7.2 and completion of the change control procedure in the Quality Agreement, the Changes in Specifications will be incorporated into the then current Specifications and the amended Specifications shall thereafter be Specifications for all purposes under this Agreement; provided, that no Changes in Specifications shall be implemented unless the prior approval of applicable Regulatory Authorities to the change, if required, has been obtained. Upon DSM’s approvalreceipt of a written notice from RELYPSA regarding any necessary Changes in Specifications (e.g. [***]), but DSM shall not commence or continue to Manufacture and RELYPSA shall have no obligation to accept or pay for Third Party Intermediate or Bulk Drug Manufactured after receipt of such notice. Any Bulk Drug or Bulk Intermediate as to which Manufacturing is completed by DSM prior to receipt of such written request for Changes in Specifications and which is Released by DSM (and is not Nonconforming) under the prior Specifications shall be paid for by RELYPSA. (b) If a dispute arises between the Parties whether implementation of Changes to Specifications is feasible (a "Technical Dispute"), the Parties will make all reasonable efforts to resolve the dispute by amicable negotiations. Executives of each Party will, as soon as possible and in any event with notification to Teva, change the Specifications to reflect any changes currently in process as of the Effective Date. Thereafter, Alexza may no later than [***] after a written request a change in the Specifications; provided that, Alexza shall not make any changes from either Party to the Specifications without Teva’s prior written approvalother, which approval shall not be unreasonably withheld or delayedmeet in good faith to resolve any Technical Dispute. In If, despite this meeting, the Parties are unable to resolve the Technical Dispute within a reasonable time, and in any event that such proposed change requires the [ * within [***] of the [ * ]written request, the Parties shall coordinate and collaborate in [ * ] and Alexza shall not implement any such change unless and until [ * ] is [ * ]. Notwithstanding Technical Dispute will, at the foregoingwritten request of either Party, if any change be referred for determination to the Specification requested by Alexza would not require any change to the Product NDA or any Regulatory Approvals an expert in the U.S. or require the submission of a Regulatory Approval application supplement substantive technical area involved in the U.S.dispute selected by mutual agreement of the Parties and acting as an expert and not as an arbitrator. If the parties cannot agree upon the expert within [***] of the written request for appointment of an expert, Alexza shall promptly notify Teva of such change through the Manufacturing JPT. [ * ] shall expert will be solely responsible for all costs (including both implementation and [ * ] costs and expenses) incurred in connection with any changes requested by Alexza, except to the extent otherwise agreed appointed by the Parties. (ii) American Arbitration Association in New York City, New York USA. Each Party will provide the expert with an initial, detailed statement of the issues in dispute and such Party’s position on such issues. Each Party shall promptly notify provide the other Party of any change expert with all information requested by him or her to aid in resolution of the Specifications that is required by dispute. The decision of the FDA or in order to comply with any Regulatory Requirement applicable to the Product for use or sale in the Field in the U.S. Any such changes expert shall be implemented at Teva’s sole expense unless such Specification changes are also CMC changes final and such CMC changes would apply to other APIs and not binding upon the Drug specifically, in which case, such CMC changes Parties. The costs of the expert (including the costs of appointment through the American Arbitration Association) shall be implemented at Alexza’s sole expense. In consultation with Teva, Alexza shall, promptly make all such regulatory required changes to the Specifications and the Parties shall coordinate and collaborate in making all necessary Regulatory Filings with the FDA to effect such change. Alexza shall compile and provide to Teva the necessary information required to support any such Regulatory Filing in the format reasonably requested by Teva, and shall provide all necessary technical assistance and services to Teva. Teva shall be responsible for making such Regulatory Filing and paying filing fees required for such Regulatory Filing. [ * ] = 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[***].

Appears in 1 contract

Sources: Manufacturing Agreement (Relypsa Inc)