Durect Development Responsibilities. (a) Notwithstanding anything herein to the contrary, the following activities with respect to Product development are to be performed by Durect (collectively “Durect Development Responsibilities”): (i) Dosage Form Development; (ii) Preclinical and Non-Clinical studies; (iii) manufacturing method development, analytical method development, validation, stability and other CMC-related activities; (iv) manufacture of Product or Product *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. Formulation, as applicable, required for all Clinical Trials through the completion of all Phase II Clinical Trials; (v) if Durect does not supply Product or Product Formulation, as applicable, for Phase III Clinical Trials or Commercialization as set forth in Section 8, management of any and all technology transfer, scale-up to commercial batch size and validation activities that may be required to enable any Person chosen by Zogenix and reasonably approved by Durect to manufacture Phase III Clinical Trial and commercial supplies of the Product or Product Formulation (as applicable); (vi) generation of necessary documents related to the Durect Development Responsibilities in order for Zogenix to perform Clinical Trials, complete Regulatory Documentation and Regulatory Approval Applications, and file for Regulatory Approvals in the Territory; and (vii) any other development activity to be performed by Durect, as mutually agreed by Zogenix and Durect. The Durect Development Responsibilities shall be detailed in a work plan (“Durect Work Plan”) agreed to in writing by the Parties which shall include the activities, timeline and detailed budget (“Durect Work Plan Budget”) associated with the Durect Development Responsibilities. Any amendments to the Durect Work Plan shall be agreed to in writing by the Parties. Durect shall use Commercially Reasonable Efforts to perform the Durect Development Responsibilities in accordance with the Durect Work Plan (including Durect Work Plan Budget and timeline set forth therein) for such Durect Development Responsibilities. (b) Durect shall invoice Zogenix for the Durect Development Costs incurred in the performance of the Durect Development Responsibilities [***]. Zogenix shall pay to Durect such Durect Development Costs within [***] from the receipt of an invoice from Durect with reasonable detail of the work performed. Notwithstanding the foregoing, Zogenix shall have no obligation to reimburse Durect’s Development Costs in excess of the then-current Durect Work Plan Budget, and Durect shall have no obligation to perform activities which would result in Durect incurring Costs in excess of the then-current Durect Work Plan Budget, in each case, until the Parties have approved any increase in the amounts set forth in the Durect Work Plan Budget. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. (c) Durect may, with the prior written consent of Zogenix (not to be unreasonably withheld, delayed or conditioned), retain Third Party contractors to perform some or all of the Durect Development Responsibilities so long as the Third Party is subject to the applicable terms of this Agreement, including confidentiality obligations to Durect that are no less stringent than the confidentiality obligations set forth in Section 10 and ownership of all work product and Intellectual Property Rights relating to the Product resulting from such work as set forth in this Agreement (including the assignment of ownership provisions set forth in Section 9.1). Durect will remain responsible to Zogenix for all Durect Development Responsibilities carried out by such Third Party contractors. (d) In the event that Durect fails to perform any material task included in the Durect Development Responsibilities, including with respect to a material delay in timelines, and provided that such failure is not the result of: (i) [***] or (ii) [***], then Zogenix shall have the right to perform such task included in the Durect Development Responsibilities itself or subcontract such tasks to a Third Party [***] to Durect, unless Durect shall have cured such default within [***]. In the event that Zogenix undertakes any task under this Section 4.4(d), upon Zogenix’s request, Durect shall, [***], promptly provide its full cooperation and assistance to transfer responsibility for, and information necessary to perform, such task to Zogenix or its designee.
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Durect Development Responsibilities. (a) Notwithstanding anything herein to the contrary, the following activities with respect to Product development are allocated to be performed by Durect (collectively “Durect Development Responsibilities”): (i) unless otherwise agreed upon by the Parties, all development activities through completion of Phase 2 [**]; (ii) Dosage Form Development; (ii) Preclinical and Non-Clinical studies; (iii) manufacturing method development, and analytical method development, validation, stability and other CMC-related activities; (iv) manufacture of Product or Product *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. Formulation, as applicable, required for all Clinical Trials through the completion of all Phase II Clinical Trials; (v) if Durect does not supply Product or Product Formulation, as applicable, for Phase III Clinical Trials or Commercialization as set forth in Section 8, management of any and all technology transfer, scale-up to commercial batch size and validation activities that may be required to enable any Person chosen by Zogenix and reasonably approved by Durect Alpharma to manufacture Phase III Clinical Trial and commercial supplies of the Product or Product Formulation (as applicable)Product; (viv) generation of necessary documents related to the Durect Development Responsibilities in order for Zogenix Alpharma to perform Clinical Trials, complete Regulatory Documentation and Regulatory Approval Applications, Trials and file for Regulatory Approvals Approval in the Territory; and (viivi) any other development activity allocated to be performed Durect by Alpharma and agreed to by Durect, as mutually agreed by Zogenix and Durect. The Durect Development Responsibilities shall be detailed in a work plan (“Durect Work Plan”) agreed to in writing by the Parties which shall include the activities, timeline and detailed budget (“Durect Work Plan Budget”) associated with the Durect Development Responsibilities. Any amendments to the Durect Work Plan shall be agreed to in writing by the Parties. Durect shall use Commercially Reasonable Efforts to perform the Durect Development Responsibilities in accordance with the Durect Work Development Plan (including Durect Work Development Plan Budget and timeline set forth therein) for such Durect Development Responsibilities.
(b) Subject to Section 7.5, Alpharma shall pay to Durect shall invoice Zogenix for the its Durect Development Costs incurred in with the performance of the Durect Development Responsibilities on a monthly basis, net [***]. Zogenix shall pay to Durect such Durect Development Costs within [***] from the receipt of an invoice therefor from Durect with reasonable detail of the work performed. Notwithstanding the foregoing, Zogenix Durect; provided that Alpharma shall have no obligation to reimburse Durect’s Development Costs in excess of the then-current Durect Work Development Plan Budget, and Durect shall have no obligation to perform activities which would result in Durect incurring Costs costs in excess of the then-current Durect Work Development Plan Budget, in each case, until the Parties have JEC has approved any increase in the amounts set forth in the Durect Work Development Plan Budget. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Durect may, with the prior written consent of Zogenix Alpharma (not to be unreasonably withheld, delayed or conditioned), retain Third Party contractors to perform some or all of the Durect Development Responsibilities so long as the Third Party is subject to the applicable terms of this Agreement, including confidentiality obligations to Durect that are no less stringent than the confidentiality obligations set forth in Section 10 10, and agrees to assign ownership of all work product and Intellectual Property Rights intellectual property rights relating to the Product resulting from such work as set forth in this Agreement (including to Durect. Durect’s selection of such Third Parties are subject to the assignment prior written approval of ownership provisions set forth in Section 9.1)Alpharma, such approval not to be unreasonably withheld, and all Durect Development Costs resulting from such Third Parties’ work shall be subject to audit by Alpharma. Durect will remain responsible to Zogenix Alpharma for all Durect Development Responsibilities carried out by such Third Party contractors.
(d) In the event that Durect fails to perform any material task [**] included in the Durect Development Responsibilities, including with respect to a material delay in timelines, and provided that such failure is not the result of: [**] (i) [***] or (ii) [***]] such Durect Development Responsibilities, then Zogenix shall have the right to perform [**] such task included in the Durect Development Responsibilities itself or subcontract such tasks to a Third Party [***] to Durect, unless Durect shall have cured such default within [***]. In the event that Zogenix undertakes any task under this Section 4.4(d), upon Zogenix’s request, Durect shall, [***], promptly provide its full cooperation and assistance to transfer responsibility for, and information necessary to perform, such task to Zogenix or its designee.
Appears in 1 contract
Durect Development Responsibilities. (a) Notwithstanding anything herein to the contrary, the following activities with respect to Product development are to be performed by Durect (collectively “Durect Development Responsibilities”): (i) Dosage Form Development; (ii) Preclinical and Non-Clinical studies; (iii) manufacturing method development, analytical method development, validation, stability and other CMC-related activities; (iv) manufacture of Product or Product *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. Formulation, as applicable, required for all Clinical Trials through the completion of all Phase II Clinical Trials; (v) if Durect does not supply Product or Product Formulation, as applicable, for Phase III Clinical Trials or Commercialization as set forth in Section 8, management of any and all technology transfer, scale-up to commercial batch size and validation activities that may be required to enable any Person chosen by Zogenix and reasonably approved by Durect to manufacture Phase III Clinical Trial and commercial supplies of the Product or Product Formulation (as applicable); (vi) generation of necessary documents related to the Durect Development Responsibilities in order for Zogenix to perform Clinical Trials, complete Regulatory Documentation and Regulatory Approval Applications, and file for Regulatory Approvals in the Territory; and (vii) any other development activity to be performed by Durect, as mutually agreed by Zogenix and Durect. The Durect Development Responsibilities shall be detailed in a work plan (“Durect Work Plan”) agreed to in writing by the Parties which shall include the activities, timeline and detailed budget (“Durect Work Plan Budget”) associated with the Durect Development Responsibilities. Any amendments to the Durect Work Plan shall be agreed to in writing by the Parties. Durect shall use Commercially Reasonable Efforts to perform the Durect Development Responsibilities in accordance with the Durect Work Plan (including Durect Work Plan Budget and timeline set forth therein) for such Durect Development Responsibilities.
(b) Durect shall invoice Zogenix for the Durect Development Costs incurred in the performance of the Durect Development Responsibilities [*** * *]. Zogenix shall pay to Durect such Durect Development Costs within [*** * *] from the receipt of an invoice from Durect with reasonable detail of the work performed. Notwithstanding the foregoing, Zogenix shall have no obligation to reimburse Durect’s Development Costs in excess of the then-current Durect Work Plan Budget, and Durect shall have no obligation to perform activities which would result in Durect incurring Costs in excess of the then-current Durect Work Plan Budget, in each case, until the Parties have approved any increase in the amounts set forth in the Durect Work Plan Budget. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Durect may, with the prior written consent of Zogenix (not to be unreasonably withheld, delayed or conditioned), retain Third Party contractors to perform some or all of the Durect Development Responsibilities so long as the Third Party is subject to the applicable terms of this Agreement, including confidentiality obligations to Durect that are no less stringent than the confidentiality obligations set forth in Section 10 and ownership of all work product and Intellectual Property Rights relating to the Product resulting from such work as set forth in this Agreement (including the assignment of ownership provisions set forth in Section 9.1). Durect will remain responsible to Zogenix for all Durect Development Responsibilities carried out by such Third Party contractors. Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
(d) In the event that Durect fails to perform any material task included in the Durect Development Responsibilities, including with respect to a material delay in timelines, and provided that such failure is not the result of: (i) [*** * *] or (ii) [*** * *], then Zogenix shall have the right to perform such task included in the Durect Development Responsibilities itself or subcontract such tasks to a Third Party [* * ***] ]to Durect, unless Durect shall have cured such default within [*** * *]. In the event that Zogenix undertakes any task under this Section 4.4(d), upon Zogenix’s request, Durect shall, [*** * *], promptly provide its full cooperation and assistance to transfer responsibility for, and information necessary to perform, such task to Zogenix or its designee.
Appears in 1 contract
Durect Development Responsibilities. (a) Notwithstanding anything herein to the contrary, the following activities with respect to Product development are allocated to be performed by Durect (collectively “Durect Development Responsibilities”): (i) unless otherwise agreed upon by the Parties, all development activities through completion of Phase 2 [* * *]; (ii) Dosage Form Development; (ii) Preclinical and Non-Clinical studies; (iii) manufacturing method development, and analytical method development, validation, stability and other CMC-related activities; (iv) manufacture of Product or Product *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. Formulation, as applicable, required for all Clinical Trials through the completion of all Phase II Clinical Trials; (v) if Durect does not supply Product or Product Formulation, as applicable, for Phase III Clinical Trials or Commercialization as set forth in Section 8, management of any and all technology transfer, scale-up to commercial batch size and validation activities that may be required to enable any Person chosen by Zogenix and reasonably approved by Durect Alpharma to manufacture Phase III Clinical Trial and commercial supplies of the Product or Product Formulation (as applicable)Product; (viv) generation of necessary documents related to the Durect Development Responsibilities in order for Zogenix Alpharma to perform Clinical Trials, complete Regulatory Documentation and Regulatory Approval Applications, Trials and file for Regulatory Approvals Approval in the Territory; and (viivi) any other development activity allocated to be performed Durect by Alpharma and agreed to by Durect, as mutually agreed by Zogenix and Durect. The Durect Development Responsibilities shall be detailed in a work plan (“Durect Work Plan”) agreed to in writing by the Parties which shall include the activities, timeline and detailed budget (“Durect Work Plan Budget”) associated with the Durect Development Responsibilities. Any amendments to the Durect Work Plan shall be agreed to in writing by the Parties. Durect shall use Commercially Reasonable Efforts to perform the Durect Development Responsibilities in accordance with the Durect Work Development Plan (including Durect Work Development Plan Budget and timeline set forth therein) for such Durect Development Responsibilities.
(b) Subject to Section 7.5, Alpharma shall pay to Durect shall invoice Zogenix for the its Durect Development Costs incurred in with the performance of the Durect Development Responsibilities Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. on a monthly basis, net [***]. Zogenix shall pay to Durect such Durect Development Costs within [*** * *] from the receipt of an invoice therefor from Durect with reasonable detail of the work performed. Notwithstanding the foregoing, Zogenix Durect; provided that Alpharma shall have no obligation to reimburse Durect’s Development Costs in excess of the then-current Durect Work Development Plan Budget, and Durect shall have no obligation to perform activities which would result in Durect incurring Costs costs in excess of the then-current Durect Work Development Plan Budget, in each case, until the Parties have JEC has approved any increase in the amounts set forth in the Durect Work Development Plan Budget. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Durect may, with the prior written consent of Zogenix Alpharma (not to be unreasonably withheld, delayed or conditioned), retain Third Party contractors to perform some or all of the Durect Development Responsibilities so long as the Third Party is subject to the applicable terms of this Agreement, including confidentiality obligations to Durect that are no less stringent than the confidentiality obligations set forth in Section 10 10, and agrees to assign ownership of all work product and Intellectual Property Rights intellectual property rights relating to the Product resulting from such work as set forth in this Agreement (including to Durect. Durect’s selection of such Third Parties are subject to the assignment prior written approval of ownership provisions set forth in Section 9.1)Alpharma, such approval not to be unreasonably withheld, and all Durect Development Costs resulting from such Third Parties’ work shall be subject to audit by Alpharma. Durect will remain responsible to Zogenix Alpharma for all Durect Development Responsibilities carried out by such Third Party contractors.
(d) In the event that Durect fails to perform any material task [* * *] included in the Durect Development Responsibilities, including with respect to a material delay in timelines, and provided that such failure is not the result of[* * *]: (i) [*** * *] or (ii) [* * ***]] such Durect Development Responsibilities, then Zogenix shall have the right to perform [* * *] such task included in the Durect Development Responsibilities itself or subcontract such tasks to a Third Party [***] to Durect, unless Durect shall have cured such default within [*** * *]. In the event that Zogenix undertakes any task under this Section 4.4(d), upon Zogenix’s request, Durect shall, [***], promptly provide its full cooperation and assistance to transfer responsibility for, and information necessary to perform, such task to Zogenix or its designee.
Appears in 1 contract
