Additional Indications. (a) The Parties may pursue Additional Indications as set forth in this Section 4.7. If either Party (the “Proposing Party”) desires to Develop the Product for an Additional Indication, then the Proposing Party will present a proposal to the other Party (the “Non-Proposing Party”) through the JSC, including a synopsis of the additional Development activities, the role of each Party with respect to Development, the timeline for the additional Development activities and the estimated costs associated with such additional Development. (b) If the Non-Proposing Party provides notice within sixty (60) days after the date of the Proposing Party’s proposal that it believes that Development of the Product for the proposed Additional Indication would satisfy the Additional Indication Rejection Condition, the determination specified in Section 4.7(f) shall be made. Within thirty (30) days after a determination (if a determination is requested) is made pursuant to Section 4.7(f) if such determination is that the Additional Indication Rejection Condition is not satisfied or within such sixty (60) day period (during which the Parties are discussing the proposal) if no such determination is requested, the Non-Proposing Party shall elect whether to participate in the Development of such Additional Indication by written notice to the Proposing Party. (c) If the Non-Proposing Party elects to participate, the Parties shall jointly Develop the Product in such Additional Indication in accordance with this Article 4, provided that [***] of the internal costs (at the FTE Rate) and external costs incurred by the Parties for Developing the Product for such Additional Indication under *** 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. an agreed budget. For clarity, if ChemoCentryx is the Proposing Party, VIT will not be required to pay any costs incurred for Development activities for the Product for an Additional Indication that are conducted solely to satisfy requirements for Regulatory Approval of the Product outside the Territory, if such requirements are in addition to requirements of the FDA and EMA. (d) In such event, the Parties shall prepare a Development Plan for the Additional Indication to include the applicable Development activities and submit such Development Plan, and an associated budget, to the JSC for review and approval, and all resulting Licensed ChemoCentryx Data or Licensed VIT Data, as applicable, will be available for use by the Parties as permitted by this Agreement. Prior to the JSC’s approval of such Development Plan, the Parties shall determine a mechanism for reconciliation and reimbursement of costs incurred by the Parties, such as quarterly payments or development milestone-based payments, and each Party shall make payments, to the extent applicable, as agreed by the Parties. (e) If the Non-Proposing Party does not elect to participate in such Development under Section 4.7(b) with respect to the proposed Additional Indication and the JSC does not determine pursuant to Section 4.7(f) that the Additional Indication Rejection Condition is satisfied, the Proposing Party shall prepare a Development Plan for the proposed Additional Indication to include such development, and upon the JSC’s approval of such Development Plan, may proceed with the Development of such Additional Indication and will be solely responsible for the conduct and costs of such Development. In such case, unless VIT receives rights pursuant to Section 4.7(h), if VIT is the Non-Proposing Party, such Additional Indication will be removed from the Field (but may be added back to the Field upon Buy-In under Section 4.7(h)). If the Non-Proposing Party does not elect to participate under Section 4.7(b) or Buy In under Section 4.7(h), the Non-Proposing Party will have no rights to use any resulting Data, except that it will have the right to use resulting Licensed ChemoCentryx Data or Licensed VIT Data, as applicable, to the extent necessary to comply with such Party’s regulatory reporting and compliance obligations, including safety reporting obligations, in its respective territory (for VIT, in the Territory and for ChemoCentryx, outside of the Territory) at no cost to the Non-Proposing Party. (f) If the Non-Proposing Party believes a proposed Additional Indication would likely have (i) a material adverse effect on the ability to Commercialize or Develop the Product for any Indication in the Field for which the Product has been, is planned to be or is being, Developed or Commercialized in the Territory as to VIT, or outside the Territory as to ChemoCentryx, (ii) a material adverse effect on Pricing or Reimbursement Approval in the Territory as to VIT, or outside the Territory as to ChemoCentryx, or (iii) a material adverse effect on the regulatory status of the Product in the Field in the Territory as to VIT, or outside the Territory as to ChemoCentryx (a proposed Additional Indication likely having an effect described in clause (i), (ii) or (iii) , the “Additional Indication Rejection Condition”), such Non-Proposing Party will have the right to refer such matter to the JSC in writing to determine whether the Additional Indication Rejection Condition is satisfied, as provided under Section 3.4. (g) If the Non-Proposing Party does not exercise its rights under Section 4.7(b) or (h), then the Proposing Party and its Affiliates may not, themselves or with or through any Third Party, Develop or Commercialize the Product in the Additional Indication in the Non-Proposing Party’s territory (i.e., the Territory if ChemoCentryx is the Proposing Party, and outside the Territory if VIT is the Proposing Party). (h) The Non-Proposing Party will have the right to “Buy In” to co-fund Development in accordance with the Development Plan for any Additional Indication for the Product for which the Non-Proposing Party declined previously to co-fund under Section 4.7(b) by written notice to the Proposing Party, following receipt of a budget and summary of costs incurred to date for such Development. If the Buy In is exercised before the first data read, the Non-Proposing party shall pay the Proposing Party an amount equal to [***] of the internal costs (at the FTE Rate) and the external costs the Proposing Party incurred to Develop the Product for such Additional Indication in accordance with the Development Plan prior to the Buy In. If the Buy In is exercised after the first *** 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. data read, the Non-Proposing party shall pay the Proposing Party an amount equal to [***] of the internal costs (at the FTE Rate) and the external costs the Proposing Party incurred to conduct such Additional Indication in accordance with the Development Plan prior to the Buy In, plus a premium of [***] of such amount (i.e., a total of [***]). In each case, the Non-Proposing Party would pay [***] of all costs incurred by the Proposing Party to Develop such Additional Indication after such Buy In, to the extent applicable, in accordance with the Development Plan and an agreed budget. (i) After notice of a Non-Proposing Party of its interest in a Buy In pursuant to Section 4.7(h), the Proposing Party and its Affiliates will promptly provide the Non-Proposing Party with any relevant information regarding the Additional Indication and any filings with the Regulatory Authorities regarding the Product for such Additional Indication as reasonably requested by the Non-Proposing Party. In addition, the Proposing Party shall cause its Affiliates and licensees/sublicensees to comply with this Section 4.7(i). (j) In connection with the Non-Proposing Party’s exercise of its Buy In, the Parties shall determine a mechanism for payment of costs incurred to Develop the Product in the Additional Indication, such as quarterly payments or development milestone-based payments, and the Non-Proposing Party shall make payments as agreed by the Parties; provided that if both Parties incur such costs, the JSC will establish a procedure for sharing and reconciling costs.
Appears in 1 contract
Sources: Collaboration and License Agreement (ChemoCentryx, Inc.)
Additional Indications. (a) The Parties may pursue Additional Indications as set forth in this Section 4.7. If In the event that either Party (the “Proposing Party”) desires to Develop develop an Additional Indication for the Product for an commercialization in the Field (by OPKO on a global basis and VF or any Sublicensee in the Territory), the development of such Additional IndicationIndication shall be proposed in writing in sufficient detail to the JSC. [***], then the Proposing Party will present a which notice is within [***] after such proposal to the other Party (the “Non-Proposing Party”) through the JSC, including a synopsis of during which time the additional Development activitiesParties are discussing the proposal, the role of each Party with respect to Development, the timeline for the additional Development activities and the estimated costs associated with such additional Development.
(b) If the Non-Proposing Party provides notice within sixty (60) days after the date of the Proposing Party’s proposal that it believes that Development of the Product for the proposed Additional Indication would satisfy the Additional Indication Rejection Condition, the determination specified in Section 4.7(f) [***] shall be madedetermined in accordance with Section 4.1(c). Within thirty (30) days [***] after a determination (if a determination is requested) is made pursuant to Section 4.7(f) if such determination is that the Additional Indication Rejection Condition is not satisfied [***] or within such sixty (60) day [***] period (during which the Parties are discussing the proposal) if no such determination is requestedproposal [***], the Nonnon-Proposing proposing Party shall elect whether to participate in the Development development of such Additional Indication by written notice to the Proposing Party.
(c) [***]). If the Nonnon-Proposing proposing Party elects to participate, the Parties shall are obligated to jointly Develop develop the Product in such Additional Indication in accordance with this Article 4, provided that ([***] of the internal costs (at the FTE Rate]) and external costs incurred by shall seek to reach a mutual written agreement on the Parties additional terms and conditions for Developing the Product for development of such Additional Indication under within next [*** Certain information on this page has been omitted and filed separately with *]. The terms of the Commission. Confidential treatment has been requested with respect to the omitted portions. an agreed budget. For claritywritten agreement, if ChemoCentryx is the Proposing Partyany, VIT will not be required to pay any costs incurred for Development activities for the Product for an Additional Indication that are conducted solely to satisfy requirements for Regulatory Approval would become part of the Product outside the Territory, if such requirements are in addition to requirements of the FDA and EMA.
(d) In such event, the Parties shall prepare a Development Plan for the Additional Indication to include the applicable Development activities and submit such Development Plan, and an associated budget, to the JSC for review and approval, and all resulting Licensed ChemoCentryx Data or Licensed VIT Data, as applicable, will data would be available for use by the Parties as permitted by VF in connection with exercising its rights under this Agreement. Prior Agreement with respect to the JSC’s approval of such Development Plan, Product in the Parties shall determine a mechanism Field and in the Territory and for reconciliation and reimbursement of costs incurred use by OPKO outside the Parties, such as quarterly payments or development milestone-based payments, and each Party shall make payments, to Territory in connection with the extent applicable, as agreed by Product in the PartiesField.
(eb) If the Non-Proposing Party does Parties do not elect to participate in such Development enter into the written mutual agreement contemplated under Section 4.7(b4.1(a) with respect to the a proposed Additional Indication and the JSC does has not determine pursuant to Section 4.7(f) that the Additional Indication Rejection Condition is satisfied[***], the Proposing proposing Party shall prepare a Development Plan for the proposed Additional Indication to include such development, and upon the JSC’s approval of such Development Plan, may proceed with the Development development of such Additional Indication and will be solely [***] responsible for the conduct and costs of such Developmentdevelopment, in which case, if VF is not a proposing Party, such Additional Indication would be removed from the Field, except not to the extent that VF receives rights pursuant to Section 4.1(d) or 4.1(e). In such case, unless VIT receives rights pursuant to Section 4.7(h), if VIT is the Non-Proposing Party, such Additional Indication will be removed from the Field (but may be added back to the Field upon Buy-In under Section 4.7(h)). If the Non-Proposing Party does not elect to participate under Section 4.7(b) or Buy In under Section 4.7(h), the Non-Proposing Party will have no rights to use any resulting Data, except that it will have the right to use resulting Licensed ChemoCentryx Data or Licensed VIT Data, as applicable, to the extent necessary to comply with such Party’s regulatory reporting and compliance obligations, including safety reporting obligations, in its respective territory (for VIT, in the Territory and for ChemoCentryx, outside of the Territory) at no cost to the Non-Proposing Party[***].
(fc) If the Nonnon-Proposing proposing Party believes a proposed Additional Indication would likely have (i) a material adverse effect on the ability to Commercialize or Develop the Product for any Indication in the Field [***] for which the Product has been, is planned to be or is being, Developed or Commercialized being developed in the Territory as to VITVF, or outside the Territory or the Field as to ChemoCentryx, (ii) a material adverse effect on Pricing or Reimbursement Approval in the Territory as to VITOPKO, or outside the Territory as to ChemoCentryx, or (iii) a material adverse effect on the regulatory status of the Product in the Field in the Territory as to VITsuch respective territory, or outside the Territory as to ChemoCentryx (a proposed Additional Indication likely having an effect described in clause (i), (ii) or (iii) , the “Additional Indication Rejection Condition”)based on [***], such Nonnon-Proposing proposing Party will have the right to refer such matter to the JSC in writing for resolution by consensus [***]. If the JSC does not reach consensus with respect to determine whether the Additional Indication Rejection Condition is satisfiedIndication, the matter will be resolved (and JSC consensus deemed to have been achieved) as provided under Section 3.421.3.
(gd) If (i) there is JSC consensus of [***], if required pursuant to Section 4.1(c), (ii) VF as the Nonnon-Proposing proposing Party does not exercise its rights under Section 4.7(b4.1(a) or and (hb), then (iii) OPKO as the Proposing proposing Party does exercise its rights under Section 4.1(a) and (b), and (iv) OPKO or any of its Affiliates may not, themselves desires to enter into a licensing or another arrangement with or through any respect to the Additional Indication with a Third Party, Develop or Commercialize then OPKO must give VF written notice of such desire, including the Product in the Additional Indication in the Non-Proposing Party’s territory (i.e., the Territory if ChemoCentryx is the Proposing Partyproposed terms thereof, and outside the Territory if VIT is the Proposing Party).
(h) The Non-Proposing Party will have the right to “Buy In” to co-fund Development in accordance with the Development Plan for any Additional Indication for the Product for which the Non-Proposing Party declined previously to co-fund under Section 4.7(b) by written notice to the Proposing Party, following receipt of a budget and summary of costs incurred to date for such Development. If the Buy In is exercised before the first data read, the Non-Proposing party shall pay the Proposing Party an amount equal to [***] of the internal costs ].
(at the FTE Ratee) and the external costs the Proposing Party incurred to Develop the Product for such Additional Indication in accordance with the Development Plan prior to the Buy In. If the Buy In (i) there is exercised after the first *** 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. data read, the Non-Proposing party shall pay the Proposing Party an amount equal to [***] of the internal costs (at the FTE Rate) and the external costs the Proposing Party incurred to conduct such Additional Indication in accordance with the Development Plan prior to the Buy In, plus a premium of [***] of such amount (i.e., a total JSC consensus of [***], if required pursuant to Section 4.1(c). In each case, (ii) VF as the Nonnon-Proposing proposing Party would pay does not exercise its rights under Section 4.1(a) and (b), (iii) OPKO as the proposing Party does exercise its rights under Section 4.1(a) and (b), and (iv) OPKO or any of its Affiliates desires to commercialize, market, promote or sell the Product in any country in the Territory for the Additional Indication, then OPKO must give VF written notice of such desire at the time of filing for Regulatory Approval in such country for such Additional Indication and [***] of all costs incurred by the Proposing Party to Develop such Additional Indication after such Buy In, to the extent applicable, in accordance with the Development Plan and an agreed budget].
(if) After notice of a Non-Proposing Party of its interest in a Buy In pursuant to Section 4.7(h)[***], the Proposing Party and its Affiliates will OPKO shall promptly provide the Non-Proposing Party with any relevant information regarding the Additional Indication and any filings with the Regulatory Authorities regarding the Product for such Additional Indication as reasonably requested by the Non-Proposing Party[***]. In addition, the Proposing Party OPKO shall cause its Affiliates and licensees/sublicensees to comply with this Section 4.7(i)4.1.
(jg) In connection with For the Non-Proposing Party’s exercise avoidance of doubt, neither OPKO nor its Buy InAffiliates and licensees shall be allowed to license or launch a Product for an Additional Indication in the Territory pursuant to Section 4.1(d) or (e) if the labeling of such Product includes the Initial Indication or any other Additional Indication for which VF has rights in the Territory.
(h) Subject to Section 4.1(g), if OPKO or its Affiliates are allowed to license or launch a Product for an Additional Indication in the Territory pursuant to Section 4.1(d) or (e), then the Parties shall determine a agree in good faith on an effective mechanism for payment of costs incurred to Develop the Product (i) prevent off-label sales in each other’s respective field in the Additional Indication, Territory of such as quarterly payments or development milestoneProduct and (ii) provide adequate compensation to the other Party for off-based payments, and label sales in its respective field in the Non-Proposing Party shall make payments as agreed by the Parties; provided that if both Parties incur Territory of such costsProduct. If such an agreement is not reached, the JSC matter will establish a procedure for sharing and reconciling costsbe resolved as provided under Section 21.3.
Appears in 1 contract
Sources: Development and License Agreement (Opko Health, Inc.)
Additional Indications. (a) The Parties may pursue In the event that either Party or its Affiliates is interested in developing a Product for an indication other than the Initial Indication (each an “Additional Indications as set forth in this Section 4.7Indication”), it shall propose such development to the JMC for discussion by the Parties. If either the other Party indicates, within sixty (60) business days of such proposal for development by the other Party (the “Proposing PartyAI Notice Period”) desires to Develop ), it is interested in jointly developing the Product for an the Additional Indication with the first Party, the Parties agree to negotiate the terms of such development, including a development plan that would satisfy the requirements of the FDA and EMA for such Additional Indication, the roles and responsibilities of the Parties in such development and the sharing of costs and expenses that would be incurred by the Parties in developing the Product for such Additional Indication. The Parties agree that such negotiations shall occur for at least sixty (60) days after the other Party referenced above has indicated its interest in the Additional Indication, or for such other period of time mutually agreed by the Parties (“Negotiation Period”). If the Parties reach mutual agreement on such terms, the Parties shall document such agreement in writing.
(b) If the Parties do not reach agreement on terms for developing the Product for the Additional Indication within the Negotiation Period, or if a Party has indicated it is not interested in, or has failed to indicate (within the AI Notice Period) it is interested in, jointly developing with the other Party the Product for the Additional Indication, then each Party shall have the Proposing right to independently develop the Product for such Additional Indication for its respective Territory, provided that, notwithstanding anything to the contrary in this Agreement (including Sections 2.1 and 11.1(f)):
(i) such right to independently develop the Product is subject to, and without limitation of, Section 4.4;
(ii) any and all Information (including raw clinical data and manufacturing information) generated by or on behalf of such Party will present a proposal (the “Developing Party”) or its Affiliates or licensees or sublicensees in the conduct of the development and commercialization of the Product in and for the Additional Indication (“Excluded Information”) shall be excluded from any and all licenses and other rights granted to the other Party (the “Non-Proposing Developing Party”) through under this Agreement, provided that if such Excluded Information was generated in the JSC, including a synopsis conduct of development and/or commercialization of the additional Development activitiesProduct in and for (A) the Additional Indication and (B) either (1) the Initial Indication or (2) a different Additional Indication which the Parties have mutually agreed to develop pursuant to Section 2.9(a) above, then the role of each Excluded Information shall not be excluded from the license and other rights granted to the Non-Developing Party with respect to Development, the timeline for the additional Development activities Initial Indication and the estimated costs associated with such additional Development.different Additional Indication;
(biii) If the Non-Proposing Developing Party provides notice within sixty (60) days after the date and its Affiliates and licensees and sublicensees shall have no right to, and shall not, refer to, rely upon or otherwise make any use of the Proposing Party’s proposal that it believes that Development of any Excluded Information, or any Regulatory Materials for the Product for the proposed Additional Indication would satisfy the Additional Indication Rejection Condition, the determination specified in Section 4.7(f) shall be made. Within thirty (30) days after a determination (if a determination is requested) is made pursuant to Section 4.7(f) if such determination is that the Additional Indication Rejection Condition is not satisfied or within such sixty (60) day period (during which the Parties are discussing the proposal) if no such determination is requested, the Non-Proposing Party shall elect whether to participate in the Development of such Additional Indication by written notice to the Proposing Party.
(c) If the Non-Proposing Party elects to participate, the Parties shall jointly Develop the Product in such Additional Indication in accordance with this Article 4, provided that [***] of the internal costs (at the FTE Rate) and external costs incurred by the Parties for Developing the Product for such Additional Indication under *** 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. an agreed budget. For clarity, if ChemoCentryx is the Proposing Party, VIT will not be required to pay any costs incurred for Development activities for the Product for an Additional Indication that are conducted solely to satisfy requirements for Regulatory Approval of the Product outside the Territory, if such requirements are in addition to requirements of the FDA and EMA.
(d) In such event, the Parties shall prepare a Development Plan for the Additional Indication to include the applicable Development activities and submit such Development Plan, and an associated budget, to the JSC for review and approval, and all resulting Licensed ChemoCentryx Data or Licensed VIT Data, as applicable, will be available for use Controlled by the Parties Developing Party or its Affiliates or licensees or sublicensees (“Excluded Regulatory Materials”), other than (A) solely as permitted by this Agreement. Prior necessary to the JSC’s approval comply with any safety reporting obligations of such Development Plan, the Parties shall determine a mechanism for reconciliation Regulatory Authority and reimbursement of costs incurred by the Parties, such as quarterly payments or development milestone-based payments, and each Party shall make payments, to the extent applicable, as agreed by the Parties.
(e) If the Non-Proposing Party does not elect to participate in such Development under Section 4.7(bB) with respect to the proposed Additional Initial Indication and any different Additional Indications which the JSC does not determine Parties have mutually agreed to develop pursuant to Section 4.7(f2.9(a) that the Additional Indication Rejection Condition is satisfied, the Proposing Party shall prepare a Development Plan for the proposed Additional Indication to include such development, and upon the JSC’s approval of such Development Plan, may proceed with the Development of such Additional Indication and will be solely responsible for the conduct and costs of such Development. In such case, unless VIT receives rights pursuant to Section 4.7(h), if VIT is the Non-Proposing Party, such Additional Indication will be removed from the Field above;
(but may be added back iv) subject to the RA Field upon Buy-In under Section 4.7(h)). If the Non-Proposing Party does not elect to participate under Section 4.7(b) or Buy In under Section 4.7(h), the Non-Proposing Party will have no Licensee’s rights to use any resulting Data, except that it will have the right to use resulting Licensed ChemoCentryx Data or Licensed VIT Data, as applicable, to the extent necessary to comply with such Party’s regulatory reporting and compliance obligations, including safety reporting obligations, in its respective territory (for VIT, in the Territory and RA Field under the RA Field License Agreement, neither Party nor any of its Affiliates or licensees or sublicensees shall seek or obtain any Product Approval for ChemoCentryx, outside of the Territory) at no cost to the Non-Proposing Party.
(f) If the Non-Proposing Party believes a proposed Additional Indication would likely have (i) a material adverse effect on the ability to Commercialize or Develop the Product for any Indication in the Field for which the Product has been, is planned to be or is being, Developed or Commercialized in the Territory as to VIT, or outside the Territory as to ChemoCentryx, (ii) a material adverse effect on Pricing or Reimbursement Approval in the Territory as to VIT, or outside the Territory as to ChemoCentryx, or (iii) a material adverse effect on the regulatory status of the Product in the Field in the Territory as to VIT, or outside the Territory as to ChemoCentryx (a proposed Additional Indication likely having an effect described in clause (i), (ii) or (iii) , the “Additional Indication Rejection Condition”), such Non-Proposing Party will have the right to refer such matter to the JSC in writing to determine whether the Additional Indication Rejection Condition is satisfied, as provided under Section 3.4.
(g) If the Non-Proposing Party does not exercise its rights under Section 4.7(b) or (h), then the Proposing Party and its Affiliates may not, themselves or with or through any Third Party, Develop or Commercialize the Product in the Additional Indication in the Non-Proposing Developing Party’s territory Territory; and
(i.e.v) for avoidance of doubt, subject to clauses (ii) and (iii) above, the Territory if ChemoCentryx is the Proposing Party, and outside the Territory if VIT is the Proposing Party).
(h) The Non-Proposing Party will have the right Field shall continue to “Buy In” to co-fund Development in accordance with the Development Plan for any Additional Indication for the Product for which the Non-Proposing Party declined previously to co-fund under Section 4.7(b) by written notice to the Proposing Party, following receipt of a budget and summary of costs incurred to date for such Development. If the Buy In is exercised before the first data read, the Non-Proposing party shall pay the Proposing Party an amount equal to [***] of the internal costs (at the FTE Rate) and the external costs the Proposing Party incurred to Develop the Product for such Additional Indication in accordance with the Development Plan prior to the Buy In. If the Buy In is exercised after the first *** 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. data read, the Non-Proposing party shall pay the Proposing Party an amount equal to [***] of the internal costs (at the FTE Rate) and the external costs the Proposing Party incurred to conduct such Additional Indication in accordance with the Development Plan prior to the Buy In, plus a premium of [***] of such amount (i.e., a total of [***]). In each case, the Non-Proposing Party would pay [***] of all costs incurred by the Proposing Party to Develop such Additional Indication after such Buy In, to the extent applicable, in accordance with the Development Plan and an agreed budget.
(i) After notice of a Non-Proposing Party of its interest in a Buy In pursuant to Section 4.7(h), the Proposing Party and its Affiliates will promptly provide the Non-Proposing Party with any relevant information regarding the Additional Indication and any filings with the Regulatory Authorities regarding the Product for such Additional Indication as reasonably requested by the Non-Proposing Party. In addition, the Proposing Party shall cause its Affiliates and licensees/sublicensees to comply with this Section 4.7(i).
(j) In connection with the Non-Proposing Party’s exercise of its Buy In, the Parties shall determine a mechanism for payment of costs incurred to Develop the Product in include the Additional Indication, such as quarterly payments or development milestone-based payments, including for purposes of the licenses granted to SpePharm and the Non-Proposing Party shall make payments as agreed by the Parties; provided that if both Parties incur such costs, the JSC will establish a procedure for sharing and reconciling costs.its Affiliates under Section 2.1
Appears in 1 contract
Sources: Exclusive License Agreement (Navidea Biopharmaceuticals, Inc.)