Independent Work. If either Party is interested in pursuing additional Development work on a Product (the “Developing Party”) for the benefit of the Exelixis Territory (in the case of Exelixis) or the Licensee Territory (in the case of Licensee) beyond what is set forth in the then current GDP, then such Party shall provide the other Party with a written detailed plan and budget for such additional work (the “Proposal”). Within [ * ] of receipt of the Proposal, the JDC or delegated team shall meet to review the Proposal and to permit the other Party (“Non-Developing Party”) an opportunity to ask questions and request additional information from the Developing Party related to the Proposal, including whether such Proposal is reasonably likely to have a material and adverse effect on the Product in the Non-Developing Party’s territory. The Parties acknowledge that it is their intent to collaborate in good faith to establish a similar review and approval process with any Future Exelixis Licensee. No additional Development work shall proceed without the approval of the JSC, and following each such approval such additional Development work and corresponding budget shall be incorporated into the GDP by the JDC. (the “Newly-Proposed Development). For any Newly-Proposed Development work, the Non-Developing Party that did not propose such work originally may elect, at its discretion, to share the Development Costs with respect to such Development work under Section 9.2(b). If the Non-Developing Party does not decide to pursue the Newly-Proposed Development work jointly with the Developing Party or does not share the Development Costs with respect to such Development work, in which event such Development work shall be deemed “Independent Work” and the Developing Party may pursue such work in the Field in its respective territory and the Development Costs with respect thereto shall be deemed Independent Work Costs and subject to Sections 4.5(d) and 9.2(b). Notwithstanding the foregoing, following the approval of the Independent Work by the JSC, the Party proposing the Independent Work may conduct such Independent Work, provided that: (A) it shall do so in accordance with the amended GDP; (B) such Independent Work shall be conducted under the oversight of the JDC and the JSC; and (C) neither Party shall conduct Independent Work in a manner that would have a material adverse effect on the Products in either Party’s territory.
Appears in 3 contracts
Samples: Collaboration and License Agreement, Collaboration and License Agreement (Exelixis, Inc.), Collaboration and License Agreement (Exelixis, Inc.)
Independent Work. If either Party is interested in pursuing additional Development work on a Product (the “Developing Party”) for the benefit of the Exelixis Territory (in the case of Exelixis) or the Licensee Collaborator Territory (in the case of LicenseeCollaborator) beyond what is set forth in the then then-current GDP, then such Party shall provide the other Party with a written detailed plan and budget for such additional work (the “Proposal”). Within [ * ] of receipt of the Proposal, the JDC or delegated team shall meet to review the Proposal and to permit the other Party (the “Non-Developing Party”) an opportunity to ask questions and request additional information from the Developing Party related to the Proposal, including whether such Proposal is reasonably likely to have a material and adverse effect on the Product in the Non-Developing Party’s territory. The Parties acknowledge that it is their intent to collaborate in good faith to establish a similar review and approval process with any Future Exelixis Licensee. No additional Development work shall proceed without the approval of the JSCJDC, and following each such approval such additional Development work and corresponding budget shall be incorporated into the GDP by the JDC. JDC (the “Newly-Proposed Development). For any Newly-Proposed Development work, the Non-Developing Party that did not propose such work originally may elect, at its discretion, to share the Development Costs with respect to such Development work under Section 9.2(b8.2(b). For clarity, for any Newly-Proposed Development by Exelixis, if Collaborator elects to share the Development Costs with respect to such Development work in accordance with Section 8.2(b), Collaborator shall have the option to [ * ]. If the Non-Developing Party does not decide to pursue the Newly-Proposed Development work jointly with the Developing Party or does not share the Development Costs with respect to such Newly-Proposed Development work, in which event such Development work shall be deemed “Independent Work” and the Developing Party may pursue such work in the Field in its respective territory and the Development Costs with respect thereto shall be deemed Independent Work Costs and subject to Sections 4.5(d4.5(b) and 9.2(b8.2(b). Notwithstanding the foregoing, following the approval of the Independent Work by the JSCJDC, the Party proposing the Independent Work may conduct such Independent Work, provided that: (A) it shall do so in accordance with the amended GDP; (B) such Independent Work shall be conducted under the oversight of the JDC and the JSCJDC; and (C) neither Party shall conduct Independent Work in a manner that would have a material adverse effect on the Products any Product(s) in either Party’s territory. For the purpose of clarification, the Development activities conducted by Exelixis for RCC (1st line and 2nd line) and HCC (2nd line) before the Effective Date shall not be treated as Independent Work. [ * ] = 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.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Independent Work. If either Party is interested in pursuing additional Development work on a Product (the “Developing Party”) for the benefit of the Exelixis Territory (in the case of Exelixis) or the Licensee Territory (in the case of Licensee) beyond what is set forth in the then current GDP, then such Party shall provide the other Party with a written detailed plan and budget for such additional work (the “Proposal”). Within [ * ] of receipt of the [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Proposal, the JDC or delegated team shall meet to review the Proposal and to permit the other Party (“Non-Developing Party”) an opportunity to ask questions and request additional information from the Developing Party related to the Proposal, including whether such Proposal is reasonably likely to have a material and adverse effect on the Product in the Non-Developing Party’s territory. The Parties acknowledge that it is their intent to collaborate in good faith to establish a similar review and approval process with any Future Exelixis Licensee. No additional Development work shall proceed without the approval of the JSC, and following each such approval such additional Development work and corresponding budget shall be incorporated into the GDP by the JDC. (the “Newly-Proposed Development). For any Newly-Proposed Development work, the Non-Developing Party that did not propose such work originally may elect, at its discretion, to share the Development Costs with respect to such Development work under Section 9.2(b). If the Non-Developing Party does not decide to pursue the Newly-Proposed Development work jointly with the Developing Party or does not share the Development Costs with respect to such Development work, in which event such Development work shall be deemed “Independent Work” and the Developing Party may pursue such work in the Field in its respective territory and the Development Costs with respect thereto shall be deemed Independent Work Costs and subject to Sections 4.5(d) and 9.2(b). Notwithstanding the foregoing, following the approval of the Independent Work by the JSC, the Party proposing the Independent Work may conduct such Independent Work, provided that: (A) it shall do so in accordance with the amended GDP; (B) such Independent Work shall be conducted under the oversight of the JDC and the JSC; and (C) neither Party shall conduct Independent Work in a manner that would have a material adverse effect on the Products in either Party’s territory.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Independent Work. If either Party is interested in pursuing additional Development work on a Product (the “Developing Party”) for the benefit of the Exelixis Territory (in the case of Exelixis) or the Licensee Collaborator Territory (in the case of LicenseeCollaborator) beyond what is set forth in the then then-current GDP, then such Party shall provide the other Party with a written detailed plan and budget for such additional work (the “Proposal”). Within [ * ] of receipt of the Proposal, the JDC or delegated team shall meet to review the Proposal and to permit the other Party (the “Non-Developing Party”) an opportunity to ask questions and request additional information from the Developing Party related to the Proposal, including whether such Proposal is reasonably likely to have a material and adverse effect on the Product in the Non-Developing Party’s territory. The Parties acknowledge that it is their intent to collaborate in good faith to establish a similar review and approval process with any Future Exelixis Licensee. No additional Development work shall proceed without the approval of the JSCJDC, and following each such approval such additional Development work and corresponding budget shall be incorporated into the GDP by the JDC. JDC (the “Newly-Proposed Development). For any Newly-Proposed Development work, the Non-Developing Party that did not propose such work originally may elect, at its discretion, to share the Development Costs with respect to such Development work under Section 9.2(b8.2(b). For clarity, for any Newly-Proposed Development by Exelixis, if Collaborator elects to share the Development Costs with respect to such Development work in accordance with Section 8.2(b), Collaborator shall have the option to [ * ]. If the Non-Developing Party does not decide to pursue the Newly-Proposed Development work jointly with the Developing Party or does not share the Development Costs with respect to such Newly-Proposed Development work, in which event such Development work shall be deemed “Independent Work” and the Developing Party may pursue such work in the Field in its respective territory and the Development Costs with respect thereto shall be deemed Independent Work Costs and subject to Sections 4.5(d4.5(b) and 9.2(b8.2(b). Notwithstanding the foregoing, following the approval of the Independent Work by the JSCJDC, the Party proposing the Independent Work may conduct such Independent Work, provided that: (A) it shall do so in accordance with the amended GDP; (B) such Independent Work shall be conducted under the oversight of the JDC and the JSCJDC; and (C) neither Party shall conduct Independent Work in a manner that would have a material adverse effect on the Products any Product(s) in either Party’s territory. For the purpose of clarification, the Development activities conducted by Exelixis for RCC (1st line and 2nd line) and HCC (2nd line) before the Effective Date shall not be treated as Independent Work.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Independent Work. If either Except as set forth below in this Section 9.2(c), each Party is interested shall bear all the internal (calculated on an FTE basis using the then current FTE Rate) and out-of-pocket costs and expenses incurred by or on account of such Party in pursuing additional Development work on a Product performing its own Independent Work (the “Developing PartyIndependent Work Costs”) for ). After the benefit completion of the Exelixis Territory (in the case of Exelixis) or the Licensee Territory (in the case of Licensee) beyond what is set forth in the then current GDPsuch Independent Work, then such Party shall provide the other Party with a written detailed plan report of such Independent Work Costs. If a Party desires to submit any portion of the Data resulting from any Independent Work conducted by the other Party and budget for related Regulatory Filings generated by the other Party to support Regulatory Approval in its territory, then such additional work (Party shall notify the “Proposal”)other Party in writing at any time upon the completion of such Independent Work. Within [ * ] of after its receipt of the Proposalsuch notice, the JDC Party conducting or delegated team having conducted such Independent Work shall meet submit to review the Proposal [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and to permit (ii) would be competitively harmful if publicly disclosed. the other Party a reasonably detailed invoice setting forth [ * ] percent (“Non-Developing Party”[ * ]%) an opportunity to ask questions and request additional information from the Developing Party related to the Proposal, including whether such Proposal is reasonably likely to have a material and adverse effect on the Product in the Non-Developing Party’s territory. The Parties acknowledge that it is their intent to collaborate in good faith to establish a similar review and approval process with any Future Exelixis Licensee. No additional Development work shall proceed without the approval of the JSC, and following each such approval such additional Development work and corresponding budget shall be incorporated into the GDP by the JDC. (the “Newly-Proposed Development). For any Newly-Proposed Development work, the Non-Developing Party that did not propose such work originally may elect, at its discretion, to share the Development Costs with respect to such Development work under Section 9.2(b). If the Non-Developing Party does not decide to pursue the Newly-Proposed Development work jointly with the Developing Party or does not share the Development Costs with respect to such Development work, in which event such Development work shall be deemed “Independent Work” and the Developing Party may pursue such work in the Field in its respective territory and the Development Costs with respect thereto shall be deemed Independent Work Costs and subject to Sections 4.5(d) and 9.2(b). Notwithstanding the foregoing, following the approval of the Independent Work Costs that would have been incurred by the JSC, the or on account of such other Party proposing the Independent Work may conduct such Independent Work, provided that: (A) it shall do so in accordance connection with the amended GDP; (Bgeneration of such Data under Section 9.2(b) as if such Independent Work shall be conducted under Costs were Development Costs. If the oversight of the JDC and the JSC; and (C) neither Party seeking to use such Data decides to use such Data to support Regulatory Approval in its territory, then such Party shall conduct Independent Work notify the other Party in a manner that would have a material adverse effect on writing and pay the Products in either amount invoiced within [ * ] after the receipt of such invoice, subject to such Party’s territoryright to audit the invoicing Party’s records and books related to such costs as provided in Section 10.4. For clarity, making such a payment does not preempt the paying Party’s audit rights under Section 10.4, which remain in full force and effect.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Independent Work. If either Subject to Section 4.7(b), and except as set forth below in this Section 8.2(b), each Party is interested shall bear all the internal (calculated on an FTE basis using the then current FTE Rate) and reasonable out-of-pocket expenses incurred by or on account of such Party in pursuing additional Development work on a Product performing its own Independent Work (the “Developing PartyIndependent Work Costs”) for ). After the benefit completion of the Exelixis Territory (in the case of Exelixis) or the Licensee Territory (in the case of Licensee) beyond what is set forth in the then current GDPsuch Independent Work, then such Party shall provide the other [ * ] = 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. Party with a written detailed plan report of such Independent Work Costs. If a Party desires to submit any portion of the Data resulting from any Independent Work conducted by the other Party and budget for related Regulatory Filings generated by the other Party to support Regulatory Approval in its territory, then such additional work (Party shall notify the “Proposal”)other Party in writing at any time upon the completion of such Independent Work. Within [ * ] of after its receipt of the Proposalsuch notice, the JDC Party conducting or delegated team having conducted such Independent Work shall meet submit to review the Proposal and to permit the other Party (“Non-Developing Party”) an opportunity to ask questions and request additional information from the Developing Party related to the Proposal, including whether such Proposal is a reasonably likely to have a material and adverse effect on the Product in the Non-Developing Party’s territory. The Parties acknowledge that it is their intent to collaborate in good faith to establish a similar review and approval process with any Future Exelixis Licensee. No additional Development work shall proceed without the approval detailed invoice setting forth [ * ] of the JSC, and following each Independent Work Costs that would have been incurred by or on account of such approval other Party in connection with the generation of such additional Development work and corresponding budget shall be incorporated into the GDP by the JDC. (the “Newly-Proposed Development). For any Newly-Proposed Development work, the Non-Developing Party that did not propose Data under Section 8.2(b) as if such work originally may elect, at its discretion, to share the Independent Work Costs were Development Costs with respect to such Development work under Section 9.2(b)Collaborative Work. If the Non-Developing Party does not decide seeking to pursue use such Data decides to use such Data to support Regulatory Approval in its territory, then such Party shall notify the Newly-Proposed Development work jointly with other Party in writing and pay the Developing Party or does not share amount invoiced (i.e., if Collaborator seeks to use the Development Costs with respect to such Development work, in which event such Development work shall be deemed “Data resulting from Exelixis’ Independent Work” and the Developing Party may pursue such work in the Field in its respective territory and the Development Costs with respect thereto shall be deemed Independent Work Costs and subject to Sections 4.5(d, twenty percent (20%) and 9.2(b). Notwithstanding the foregoing, following the approval of [ * ] of the Independent Work by Costs) within [ * ] after the JSCreceipt of such invoice. For clarity, making such a payment does not preempt the Party proposing the Independent Work may conduct such Independent Work, provided that: (A) it shall do so in accordance with the amended GDP; (B) such Independent Work shall be conducted under the oversight of the JDC and the JSC; and (C) neither Party shall conduct Independent Work in a manner that would have a material adverse effect on the Products in either paying Party’s territoryaudit rights under Section 9.4, which remain in full force and effect.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Independent Work. If either (i) Except as set forth below in this Section 8.2(b), each Party is interested shall bear all of the Development Costs incurred by or on account of such Party in pursuing additional Development work on a Product performing its own Independent Work (the “Developing PartyIndependent Work Costs”) for ). After the benefit completion of the Exelixis Territory (in the case of Exelixis) or the Licensee Territory (in the case of Licensee) beyond what is set forth in the then current GDPsuch Independent Work, then such Party shall provide the other Party with a written detailed plan and budget for report of such additional work (the “Proposal”)Independent Work Costs. Within [ * ] of receipt If a Party desires to submit any portion of the Proposal, the JDC or delegated team shall meet to review the Proposal and to permit Data resulting from any Independent Work conducted by the other Party (“Non-Developing Party”) an opportunity and related Regulatory Filings generated by the other Party to ask questions and request additional information from support Regulatory Approval in its own territory, then such Party shall notify the Developing other Party related in writing at any time following the completion of such Independent Work. Within [*] after its receipt of such notice, the Party conducting or having conducted such Independent Work shall submit to the Proposalother Party a reasonably detailed invoice setting forth [*] the Independent Work Costs that such other Party would have incurred in connection with the generation of such Data if such Independent Work Costs were Development Costs shared jointly by the Parties as set forth in Section 8.2(a) (e.g., including whether with respect to Independent Work conducted by Rigel, Kissei would be responsible for [*] any Independent Work Costs pertaining to the Kissei Territory). Should there be no Independent Work Costs pertaining to the Kissei Territory for Rigel Independent Work and Kissei wishes to reference the Data from such Proposal is reasonably likely Independent [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to have a material Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(ii) Notwithstanding the foregoing Section 8.2(b)(i), if Rigel conducts Independent Work in the Kissei Territory and adverse effect on obtains MAA Approval of the Product in any country in the Non-Developing Party’s territory. The Parties acknowledge that it is their intent to collaborate in good faith to establish a similar review and approval process with Kissei Territory for any Future Exelixis Licensee. No additional Development work shall proceed without the approval new Indication or new formulation of the JSC, and following each such approval such additional Development work and corresponding budget shall be incorporated into the GDP by the JDC. (the “Newly-Proposed Development). For any Newly-Proposed Development work, the Non-Developing Party that did not propose such work originally may elect, at its discretion, to share the Development Costs with respect to such Development work under Section 9.2(b). If the Non-Developing Party does not decide to pursue the Newly-Proposed Development work jointly with the Developing Party or does not share the Development Costs with respect to such Development work, in which event such Development work shall be deemed “Independent Work” and the Developing Party may pursue such work in the Field in its respective territory and the Development Costs with respect thereto shall be deemed Independent Work Costs and subject to Sections 4.5(d) and 9.2(b). Notwithstanding the foregoing, following the approval Product as a result of the Independent Work by the JSC, the Party proposing the Independent Work may conduct such Independent Work, provided thatKissei shall be obligated to reimburse Rigel for the greater of: (A) it shall do so [*] any of Rigel’s Independent Work Costs for Development activities specifically performed to support the MAA filing in accordance with such country in the amended GDPKissei Territory; and (B) such Independent Work shall be conducted under the oversight pro-rata share of the JDC total costs for the global Development of such Product for such Indication allocated to the country(ies) or region(s) in the Kissei Territory [*]. Upon Rigel’s receipt of such payment in full, Kissei shall have the right and obligation to Commercialize, itself or through a Sublicensee, such Product under such MAA Approval. In addition, Kissei shall pay to Rigel the JSC; and (Cmilestone payment(s) neither Party shall conduct Independent Work set forth in a manner Section 8.3 triggered by such Product for such Indication in such country that would have been paid if such Development and regulatory activities were conducted by Kissei (or its Affiliate or Sublicensee) instead of Rigel (i.e., MAA submission and approval milestone payments for such Indication) (the “Missed Milestone Payments”), by making a material adverse effect on [*] payment to Rigel that is equal to [*] (the Products “Milestone Catch-Up Payment”) until the total amount of such Milestone Catch-Up Payments made by Kissei in either Party’s territoryaggregate equals the amount of such Missed Milestone Payments. For clarity, such Milestone Catch-Up Payments shall commence with [*] and shall be in addition to the Transfer Price payments for such Product paid by Kissei to Rigel under Section 8.5(a) and ends at the end of the Commercialization Term.
Appears in 1 contract
Samples: Collaboration and License Agreement (Rigel Pharmaceuticals Inc)
Independent Work. (a) If either Party (the “Developing Party”) is interested in pursuing additional Development work on a Product (the “Developing Party”[*]) for the benefit of (a) the Exelixis Rigel Territory (or Kissei Territory in the case of ExelixisRigel, or (b) or the Licensee Kissei Territory (in the case of Licensee) Kissei, in each case beyond what is set forth in the then then-current GDPDevelopment Plan, then such Party shall provide the other Party (the “Non-Developing Party”) with a written detailed plan and budget for such additional work (the “Proposal”). Within [ * [*] of after the Non-Developing Party’s receipt of the Proposal, the JSC (or JDC or other delegated team team) shall meet to review the Proposal and to permit the other Party (“Non-Developing Party”) Party an opportunity to ask questions and request additional information from the Developing Party related to the Proposal, including whether such Proposal is reasonably likely to have a material and any adverse effect on the Development or Commercialization of the Product in the Non-Developing Party’s territory. The Parties acknowledge that it is their intent to collaborate in good faith to establish a similar review and approval process with No work under any Future Exelixis Licensee. No additional Development work Proposal shall proceed without unless and until the approval JSC determines in its reasonable discretion that such Proposal is not likely to adversely affect the Development or Commercialization of the JSCProduct in the Non-Developing Party’s territory, and following each such approval determination, if any, the JSC shall incorporate such additional Development work and the corresponding budget shall be incorporated into the GDP by the JDC. Development Plan (the “Newly-Proposed DevelopmentDevelopment Work”). For any Newly-Proposed Development workWork, the Non-Developing Party that did not propose such work originally may elect, at its discretion, to share the Development Costs with respect to such Development work under Section 9.2(b8.2(a). , and following such election such Newly-Proposed Development Work shall be Joint Development Work, but subject to the cost-sharing terms set forth in Section 8.2(a).
(b) If the Non-Developing Party does elects to not decide to pursue the Newly-Proposed Development work Work jointly with the Developing Party or and does not share the Development Costs with respect to such Development workwork as provided under Section 8.2(a), in which event such Development work shall be deemed the “Independent Work” of the Developing Party and the Developing Party may pursue such work in subject to the Field in its respective territory remainder of this Section 4.3, and the Development Costs with respect thereto shall be deemed Independent Work Costs and subject to Sections 4.5(d) and 9.2(bSection 8.2(b). Notwithstanding Following the foregoing, following the approval amendment of the Independent Work Development Plan by the JSCJSC to include any Newly-Proposed Development Work that is Independent Work, the Developing Party proposing the Independent Work may conduct such Independent Work, provided that: (Ax) it shall do so in accordance with the amended GDP; Development Plan, (By) it shall provide updates to the JSC with respect to such Independent Work shall be conducted under the oversight of the JDC and the JSC; at each regularly scheduled JSC meeting, and (Cz) neither Party shall conduct any Independent Work in a manner that would have a material have, or would be reasonably expected to have, any adverse effect on the Products Development or Commercialization of the Product in either Party’s territory. Rigel shall have the right to conduct Development activities in the Kissei Territory as Independent Work, such as the Development of the Product to support Regulatory [*] = 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.
(c) Notwithstanding the foregoing, Rigel shall have the right to conduct any Development activities with respect to the Compound or Product in the Rigel Territory outside the scope of the Development Plan. Such Development activities shall be: (i) deemed Rigel Only Development Work for the purpose of this Agreement, (ii) at Rigel’s sole cost and expense pursuant to Section 4.5(a), and (iii) be subject to Section 4.7(d) such that Kissei shall have the right of reference to the data generated in such Development activities without any reimbursement obligation to Rigel.
Appears in 1 contract
Samples: Collaboration and License Agreement (Rigel Pharmaceuticals Inc)
Independent Work. If either Except as set forth below in this Section 9.2(c), each Party is interested shall bear all the internal (calculated on an FTE basis using the then current FTE Rate) and out-of-pocket costs and expenses incurred by or on account of such Party in pursuing additional Development work on a Product performing its own [ * ] = 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. Independent Work (the “Developing PartyIndependent Work Costs”) for ). After the benefit completion of the Exelixis Territory (in the case of Exelixis) or the Licensee Territory (in the case of Licensee) beyond what is set forth in the then current GDPsuch Independent Work, then such Party shall provide the other Party with a written detailed plan report of such Independent Work Costs. If a Party desires to submit any portion of the Data resulting from any Independent Work conducted by the other Party and budget for related Regulatory Filings generated by the other Party to support Regulatory Approval in its territory, then such additional work (Party shall notify the “Proposal”)other Party in writing at any time upon the completion of such Independent Work. Within [ * ] of after its receipt of the Proposalsuch notice, the JDC Party conducting or delegated team having conducted such Independent Work shall meet submit to review the Proposal and to permit the other Party a reasonably detailed invoice setting forth [ * ] percent (“Non-Developing Party”[ * ]%) an opportunity to ask questions and request additional information from the Developing Party related to the Proposal, including whether such Proposal is reasonably likely to have a material and adverse effect on the Product in the Non-Developing Party’s territory. The Parties acknowledge that it is their intent to collaborate in good faith to establish a similar review and approval process with any Future Exelixis Licensee. No additional Development work shall proceed without the approval of the JSC, and following each such approval such additional Development work and corresponding budget shall be incorporated into the GDP by the JDC. (the “Newly-Proposed Development). For any Newly-Proposed Development work, the Non-Developing Party that did not propose such work originally may elect, at its discretion, to share the Development Costs with respect to such Development work under Section 9.2(b). If the Non-Developing Party does not decide to pursue the Newly-Proposed Development work jointly with the Developing Party or does not share the Development Costs with respect to such Development work, in which event such Development work shall be deemed “Independent Work” and the Developing Party may pursue such work in the Field in its respective territory and the Development Costs with respect thereto shall be deemed Independent Work Costs and subject to Sections 4.5(d) and 9.2(b). Notwithstanding the foregoing, following the approval of the Independent Work Costs that would have been incurred by the JSC, the or on account of such other Party proposing the Independent Work may conduct such Independent Work, provided that: (A) it shall do so in accordance connection with the amended GDP; (Bgeneration of such Data under Section 9.2(b) as if such Independent Work shall be conducted under Costs were Development Costs. If the oversight of the JDC and the JSC; and (C) neither Party seeking to use such Data decides to use such Data to support Regulatory Approval in its territory, then such Party shall conduct Independent Work notify the other Party in a manner that would have a material adverse effect on writing and pay the Products in either amount invoiced within [ * ] after the receipt of such invoice, subject to such Party’s territoryright to audit the invoicing Party’s records and books related to such costs as provided in Section 10.4. For clarity, making such a payment does not preempt the paying Party’s audit rights under Section 10.4, which remain in full force and effect.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Independent Work. If either Party is interested in pursuing additional Development work on a Product (the “Developing Party”) for the benefit of the Exelixis Territory (in the case of Exelixis) or the Licensee Collaborator Territory (in the case of LicenseeCollaborator) beyond what is set forth in the then then-current GDP, then such Party shall provide the other Party with a written detailed plan and budget for such additional work (the “Proposal”). Within [ * ] of receipt of the Proposal, the JDC or delegated team shall meet to review the Proposal and to permit the other Party (the “Non-Developing Party”) an opportunity to ask questions and request additional information from the Developing Party related to the Proposal, including whether such Proposal is reasonably likely to have a material and adverse effect on the Product in the Non-Developing Party’s territory. The Parties acknowledge that it is their intent to collaborate in good faith to establish a similar review and approval process with any Future Exelixis Licensee. No additional Development work shall proceed without the approval of the JSCJDC, and following each such approval such additional Development work and corresponding budget shall be incorporated into the GDP by the JDC. JDC (the “Newly-Proposed Development). For any Newly-Proposed Development work, the Non-Developing Party that did not propose such work originally may elect, at its discretion, to share the Development Costs with respect to such Development work under Section 9.2(b8.2(b). For clarity, for any Newly-Proposed Development by Exelixis, if Collaborator elects to share the Development Costs with respect to such Development work in accordance with Section 8.2(b), Collaborator shall have the option to [ * ]. If the Non-Developing Party does not decide to pursue the Newly-Proposed Development work jointly with the Developing Party or does not share the Development Costs [ * ] = 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. with respect to such Newly-Proposed Development work, in which event such Development work shall be deemed “Independent Work” and the Developing Party may pursue such work in the Field in its respective territory and the Development Costs with respect thereto shall be deemed Independent Work Costs and subject to Sections 4.5(d4.5(b) and 9.2(b8.2(b). Notwithstanding the foregoing, following the approval of the Independent Work by the JSCJDC, the Party proposing the Independent Work may conduct such Independent Work, provided that: (A) it shall do so in accordance with the amended GDP; (B) such Independent Work shall be conducted under the oversight of the JDC and the JSCJDC; and (C) neither Party shall conduct Independent Work in a manner that would have a material adverse effect on the Products any Product(s) in either Party’s territory. For the purpose of clarification, the Development activities conducted by Exelixis for RCC (1st line and 2nd line) and HCC (2nd line) before the Effective Date shall not be treated as Independent Work.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)