Additional Indications. In further recognition by the Parties that ICN's development studies with respect to other indications of the Product should not interfere with the development activities conducted by Schering with respect to the chronic hepatitis C indication, if ICN pursues an additional indication for the Product in any country in the Territory, then (subject to compliance with Section 3.1(f) in the case of a hepatitis C indication): (i) ICN may so notify Schering by providing Schering with a description of ICN's development activities, all associated preclinical and clinical data, ICN's aggregate costs and expenses incurred in pursuing such development activities to date, and the estimated costs and expenses for remaining activities, and such other information as Schering may reasonably request. In such event, Schering shall have the right, exercisable by notice to ICN given not later than 75 days after receipt of the notice from ICN, to elect to have such indication become included in and subject to the terms and conditions of this Agreement (including without limitation, those relating to territory and royalties), and all definitions shall be appropriately adjusted to include such additional indication, effective upon receipt by ICN of Regulatory Approval with respect to such indication in any country in the Territory. If Schering exercises such right, then (A) Schering shall assume and be responsible for any and all further development activities with respect to such indication in accordance with the terms and conditions of this Agreement, and (B) promptly after receiving such Regulatory Approval, ICN shall notify Schering of ICN's aggregate costs and expenses incurred in pursuing Regulatory Approval for such indication, and Schering shall reimburse ICN for such costs and expenses within 45 days after receipt of an invoice from ICN. Schering shall have the right to audit such costs and expenses in accordance with the provisions of Section 6.10(b). (ii) If ICN does not provide such notice to Schering or if Schering declines to exercise such rights, then ICN shall be free to pursue such indication without further obligation to Schering, except as expressly provided under this Agreement; provided, however, that (i) ICN shall not sell the Product for any such indication in any country in the Territory until five years after the date of the first commercial sale in such country by Schering of the Product for the chronic hepatitis C indication, and (ii) ICN shall not sublicense any third party to develop, make, have made, use, sell or distribute the Product for such indication in such countries and shall only sell the Product in such countries directly or through its direct or indirect subsidiaries, and only under the brand name for the Product which ICN is then using for the hepatitis C indication.
Appears in 4 contracts
Sources: Exclusive License and Supply Agreement (Icn Pharmaceuticals Inc), Exclusive License and Supply Agreement (Icn Pharmaceuticals Inc), Exclusive License and Supply Agreement (Ribapharm Inc)
Additional Indications. In further recognition by 4.3.1. ▇▇▇▇▇▇ and Onconova shall work together in good faith to maximize the value of the Licensed Product in future indications in hematology, oncology and other indications (beyond the Initial Indications). Not less than once every **, Onconova shall review with ▇▇▇▇▇▇ potential new indications for the Licensed Product in the Licensed Field beyond the Initial Indications (each such indication, an “Additional Indication”) within the Licensed Territory. Onconova shall inform ▇▇▇▇▇▇ in writing of such Additional Indication(s) and the Parties that ICN's development studies with respect shall discuss the estimated timing, cost, revenue expectations, pre-clinical or clinical data and other relevant aspects of such Additional Indication(s). ▇▇▇▇▇▇ shall, within ** of receipt of Onconova’s written proposal: (a) inform Onconova in writing of its intent to other indications of the Product should not interfere with participate in the development activities conducted by Schering with respect of such Additional Indication(s) or (b) inform Onconova in writing that it is deferring the decision to the chronic hepatitis C indication, if ICN pursues an additional indication for the Product in any country participate in the Territory, then (subject clinical development for such Additional Indication(s). ▇▇▇▇▇▇’▇ failure to compliance with Section 3.1(f) respond to Onconova’s proposal within such ** period shall be deemed ▇▇▇▇▇▇’▇ deferring the decision to participate in the case of a hepatitis C indication):development for such Additional Indication(s).
(i) ICN If ▇▇▇▇▇▇ chooses to participate in development of an Additional Indication at inception pursuant to Section 4.3.1, then:
(1) (A) Onconova and ▇▇▇▇▇▇ shall work jointly to develop the Licensed Product for the Additional Indication in the Licensed Territory, (B) the Additional Indication shall be developed pursuant to Onconova’s written proposal provided under Section 4.3.1 (as such may so notify Schering be modified from time-to-time by providing Schering with a description mutual agreement of ICN's the Parties), and (C) except as provided in the last sentence of Section 6.2.1, ** shall be responsible for and shall pay for ** of all research and development activities, all associated preclinical and clinical data, ICN's aggregate costs and expenses incurred in pursuing allocable to the research and development of such development activities to date, and Additional Indication for the estimated costs and expenses for remaining activities, and such other information as Schering may reasonably request. In such event, Schering shall have the right, exercisable by notice to ICN given not later than 75 days after Licensed Territory; and
(2) Upon receipt of Marketing Approval for an Additional Indication from the notice from ICN▇▇▇ ▇▇▇▇▇▇ shall pay to Onconova ** for such Additional Indication. If, to elect to have such indication become included in and subject to instead of a centralized EMA filing, the terms and conditions of this Agreement (including without limitation, those relating to territory and royalties), and all definitions shall be appropriately adjusted to include such additional indication, effective upon receipt by ICN of Regulatory Approval with respect to such indication in any country in was sought from individual countries within the Licensed Territory. If Schering exercises such right, then (A) Schering upon receipt of Marketing Approval for an Additional Indication from the applicable Regulatory Authorities in the earlier to occur of either **, ▇▇▇▇▇▇ shall assume and be responsible pay to Onconova ** for any and all further development activities with respect to such indication in accordance with the terms and conditions of this Agreement, Additional Indication and (B) promptly after receiving such Regulatory Approval, ICN shall notify Schering upon receipt of ICN's aggregate costs and expenses incurred in pursuing Regulatory Marketing Approval for such indicationan Additional Indication from the applicable Regulatory Authorit(y/ies) for **, and Schering shall reimburse ICN as applicable, for such costs and expenses within 45 days after receipt Additional Indication, ▇▇▇▇▇▇ shall pay to Onconova **for such Additional Indication. Further, all Net Sales of an invoice from ICN. Schering the Licensed Product for such Additional Indication shall have the right to audit such costs and expenses in accordance be aggregated with the provisions of Section 6.10(b)all other Licensed Product Net Sales, but shall bear royalties at **.
(ii) If ICN does not provide such notice ▇▇▇▇▇▇ defers the decision to Schering or if Schering declines to exercise such rights, then ICN shall be free to pursue such indication without further obligation to Schering, except as expressly provided under this Agreement; provided, however, that (i) ICN shall not sell the Product for any such indication participate in any country in the Territory until five years after the date development of the first commercial sale in such country by Schering of Additional Indication at inception pursuant to Section 4.3.1, Onconova shall have the exclusive right, but not the obligation, to further develop the Licensed Product for the chronic hepatitis C indicationLicensed Territory at its own cost and expense. Onconova will consult with ▇▇▇▇▇▇ during development and may advance such development, at Onconova’s expense, until such time as Onconova has generated **. Prior to submission of a Drug Approval Application for the Additional Indication in the European Union, Onconova will provide ▇▇▇▇▇▇ in writing estimated timing, cost, pre-clinical or clinical data and other relevant aspects of such Additional Indication and the associated Drug Approval Application. ▇▇▇▇▇▇ shall have the right, within ** from the provision of such information by Onconova, to elect whether it wishes to participate in the further development of such Additional Indication, including filing of a Drug Approval Application in the European Union, or to again defer its decision, by providing written notice thereof to Onconova. If ▇▇▇▇▇▇ elects to participate in such further development of the Additional Indication, ▇▇▇▇▇▇ shall reimburse Onconova for ** of all of the research and development expenses incurred by Onconova and its Affiliates for such Additional Indication through such time that are allocable to the Licensed Territory and shall thereafter be responsible for and shall pay for ** of all additional research and development costs and expenses for such Additional Indication that are allocable to the Licensed Territory, including preparation and filing of Drug Approval Applications for the Licensed Territory. Upon receipt of Marketing Approval for the Additional Indication from the EMA, ▇▇▇▇▇▇ shall pay to Onconova ** for such Additional Indication. If, instead of a centralized EMA filing, the Regulatory Approval was sought from individual countries within the Licensed Territory, then (A) upon receipt of Marketing Approval for an Additional Indication from the applicable Regulatory Authorities in the earlier to occur of **, or (ii) **, ▇▇▇▇▇▇ shall pay to Onconova ** for such Additional Indication and (B) upon receipt of Marketing Approval for an Additional Indication from the applicable Regulatory Authorit(y/ies) for the remaining **, as applicable, for such Additional Indication, ▇▇▇▇▇▇ shall pay to Onconova ** for such Additional Indication (in either case, pursuant to Section 9.2.4) Further, all Net Sales of Licensed Product for such Additional Indication(s) shall be aggregated with all other Licensed Product Net Sales, but **, and shall be calculated in the manner described in Section 4.3.1(i)(2) above. ▇▇▇▇▇▇’▇ failure to respond to Onconova’s proposal within the ** period referenced above shall be deemed ▇▇▇▇▇▇’▇ deferring the decision to participate in the development for such Additional Indication.
(iii) If ▇▇▇▇▇▇ had previously deferred its decision to participate in the development of the Additional Indication and Onconova obtains a Marketing Approval for the Licensed Product for such Additional Indication from the EMA or, if filed separately in individual countries within the Licensed Territory, from the applicable Regulatory Authorities in the earlier to occur of **, ▇▇▇▇▇▇ shall reimburse Onconova for ** of all of the research and development expenses incurred by Onconova for such Additional Indication that are allocable to the Licensed Territory. Further, provided that the Additional Indication has estimated peak gross sales greater than or equal to ** (or such lesser amount as may be mutually agreed by the Parties) on a ** basis (as mutually agreed upon by the Parties in writing or, if the Parties are not able to mutually agree on such estimated peak gross sales, as determined pursuant to Section 16.14), ▇▇▇▇▇▇ shall be obligated to pay to Onconova: (A) ** for each such Additional Indication to Onconova if the Marketing Approval for the Licensed Product for the Additional Indication was received from the EMA or (B)(1) ** for each such Additional Indication if the Marketing Approval for the Licensed Product for such Additional Indication was received in the earlier to occur of either **, and (ii2) ICN shall not sublicense any third party to develop, make, have made, use, sell or distribute ** for each such Additional Indication upon receipt of the Marketing Approval for the Licensed Product for such indication Additional Indication in the remaining **, as applicable (in either case, pursuant to Section 9.2.4). Further, all Net Sales of Licensed Product for such countries Additional Indication(s) shall be aggregated with all other Licensed Product Net Sales, but **, and shall be calculated in the manner described in Section 4.3.1(i)(2) above. ▇▇▇▇▇▇ shall thereafter be obligated to commercialize the Licensed Product for such Additional Indication(s) pursuant to Article VII.
(iv) The amount of the ** set forth in this Section 4.3 apply only sell to Additional Indications within hematology and oncology. For all Additional Indications outside hematology and oncology, the research and development cost participation and royalties would be the same as in hematology and oncology, but the approval milestone would be commensurate with the market opportunity for the Additional Indication, as determined by mutual agreement of the Parties, and in the absence of such mutual agreement, pursuant to Section 16.14.
(v) Under no circumstances shall Onconova have the right to commercialize the Licensed Product in such countries directly the Licensed Territory, either by itself or through its direct one or indirect subsidiaries, and only under the brand name more Third Parties whether for the Product which ICN is then using Initial Indications or any other indication including, without limitation, the Additional Indications.
(vi) For purposes of determining what portion of the costs and expenses for the hepatitis C indicationdevelopment of an Additional Indication are ‘allocable’ to the Licensed Territory and should be borne by ▇▇▇▇▇▇, consideration shall be given not only to the existing Licensees and licensed territories for such Additional Indication but also to potential worldwide sales for the Additional Indication and such other factors as the Parties reasonably determine in good faith. The portion that is allocated to ▇▇▇▇▇▇ must be mutually agreed by the Parties in writing and any disputes as to the allocation of the costs and expenses shall be resolved pursuant to Section 16.14.
Appears in 3 contracts
Sources: Development and License Agreement (Onconova Therapeutics, Inc.), Development and License Agreement (Onconova Therapeutics, Inc.), Development and License Agreement (Onconova Therapeutics, Inc.)
Additional Indications. In further recognition by (a) Proposal. If either Party (the Parties that ICN's development studies with respect “Proposing Party”) desires to other indications pursue additional Development of a Product in order to seek Regulatory Approval of the Product should not interfere in one or more Additional Indications for the benefit of (a) the Ovid Territory and Licensee Territory in the case of Ovid, or (b) the Licensee Territory in the case of Licensee, in each case beyond what is set forth in the then-current Development Plan, then such Party shall provide the other Party (the “Reviewing Party”) with a written detailed plan and budget for such additional work (the development activities conducted by Schering with respect “Proposal”). Within [***] after the Reviewing Party’s receipt of the Proposal (or at such other time as the Parties may mutually agree), the JPT shall meet to review and discuss in good faith the Proposal and permit the Reviewing Party an opportunity to ask questions and request additional information from the Proposing Party related to the chronic hepatitis C indicationProposal, if ICN pursues an additional indication for including whether such Proposal is reasonably likely to have any adverse effect on the Development or Commercialization of the Product in the Reviewing Party’s territory. No work under any country Proposal shall proceed unless and until (i) the CGB determines in its reasonable discretion that such Proposal is not likely to adversely affect the Development or Commercialization of the Product in the TerritoryReviewing Party’s territory, then and (subject to compliance with Section 3.1(fii) in the case of a hepatitis C indication):
Licensee as the Proposing Party, Ovid consents in writing to such activities being included as Joint Development Activities, or to Licensee performing such additional Development as Licensee Territory Development Activities (where such Development Activities solely and specifically relate to the Licensee Territory), or as Independent Development Activities, such consent not to be unreasonably withheld. For clarity, (i) ICN may so notify Schering by providing Schering with a description Licensee’s final decision right under Section 3.4(b)(ii) shall not apply to Licensee Territory Development Activities proposed in connection of ICN's development activitiesinitiation of Development for any Additional Indication, all associated preclinical and clinical data, ICN's aggregate costs and expenses incurred but once Development Activities have been commenced in pursuing such development activities to date, and the estimated costs and expenses for remaining activities, and such other information as Schering may reasonably request. In such event, Schering shall have the right, exercisable by notice to ICN given not later than 75 days after receipt of the notice from ICN, to elect to have such indication become included Additional Indication in and for the Licensee Territory, any further Licensee Territory Development Activities proposed by Licensee in respect of such Additional Indication shall be subject to the terms and conditions of this Agreement (including without limitation, those relating to territory and royalties), and all definitions shall be appropriately adjusted to include such additional indication, effective upon receipt by ICN of Regulatory Approval with respect to such indication process set forth in any country in the Territory. If Schering exercises such right, then (ASection 4.2(b) Schering shall assume and be responsible for any and all further development activities with respect to such indication in accordance with the terms and conditions of this Agreement, and (B) promptly after receiving such Regulatory Approval, ICN shall notify Schering of ICN's aggregate costs and expenses incurred in pursuing Regulatory Approval for such indication, and Schering shall reimburse ICN for such costs and expenses within 45 days after receipt of an invoice from ICN. Schering shall have the right to audit such costs and expenses in accordance with the provisions of Section 6.10(b).
(ii) If ICN does not provide such notice to Schering or if Schering declines to exercise such rights, then ICN shall be free to pursue such indication without further obligation to Schering, except as expressly provided under this Agreement; provided, however, that (i) ICN shall not sell the Product for any such indication in any country in the Territory until five years after the date of the first commercial sale in such country by Schering of the Product for the chronic hepatitis C indication, and (ii) ICN shall Ovid will not sublicense develop in the Licensee Territory any third party to develop, make, have made, use, sell or distribute the Product for such indication in such countries and shall only sell the Product in additional indications other than Rare Diseases without Licensee’s prior written consent. Following each such countries directly or through its direct or indirect subsidiariesdetermination and, if applicable, consent, the CGB shall incorporate such additional Development activities and only under the brand name for corresponding budget into the Product which ICN is then using for Development Plan (the hepatitis C indication“Additional Development Activities”).
Appears in 2 contracts
Sources: Collaboration and License Agreement (Ovid Therapeutics Inc.), Collaboration and License Agreement (Ovid Therapeutics Inc.)
Additional Indications. In further recognition by AMAG shall notify the Parties that ICN's development studies with respect JSC of each indication (other than the Initial Indication) for which AMAG is Developing, seeking Regulatory Approval of, or Commercializing the Product in the U.S. (each, an “Additional Indication”), no later than the first dosing of a patient in a Phase III Clinical Trial for such Additional Indication anywhere in the AMAG Territory. Within sixty (60) days of the JSC’s receipt of such notice, 3SBio shall notify AMAG, through its JSC representatives, whether 3SBio agrees to other indications Develop the Product for such Additional Indication in the Licensed Territory. If 3SBio does not so agree, then such Additional Indication shall be an “Independent Indication” and AMAG shall be solely responsible, at its discretion and expense, for Developing and seeking Regulatory Approval of the Product should not interfere with for the development activities conducted by Schering with respect Independent Indication in the Licensed Territory. 3SBio shall have no rights to the chronic hepatitis C indication, if ICN pursues an additional indication for Develop or Commercialize the Product in any country Independent Indication without the prior written consent of AMAG, which may be granted or withheld at AMAG’s sole discretion, and such Independent Indication shall be excluded from the scope of this Agreement. If 3SBio agrees to Develop the Product for such Additional Indication in the Licensed Territory, then (subject the Additional Indication shall be a “Co-Developed Indication.” From time to compliance with Section 3.1(f) time, 3SBio may propose to the JSC that it Develop, seek Regulatory Approval of, or Commercialize the Product in the case Licensed Territory in one or more indications other than the Initial Indication (each, a “3SBio Proposed Indication”). Within sixty (60) days of a hepatitis C indication):
(i) ICN may so notify Schering by providing Schering with a description of ICN's development activities, all associated preclinical and clinical data, ICN's aggregate costs and expenses incurred in pursuing such development activities to date, and the estimated costs and expenses for remaining activities, and such other information as Schering may reasonably request. In such event, Schering shall have the right, exercisable by notice to ICN given not later than 75 days after JSC’s receipt of such notice, AMAG shall notify 3SBio whether AMAG agrees to permit the notice from ICN, to elect to have Development and Commercialization of the Product for such indication become included in and subject to the terms and conditions of this Agreement (including without limitation, those relating to territory and royalties), and all definitions shall be appropriately adjusted to include such additional indication, effective upon receipt by ICN of Regulatory Approval with respect to such indication in any country 3SBio Proposed Indication in the Territory. If Schering exercises such right, then (A) Schering shall assume and be responsible for any and all further development activities with respect to such indication Licensed Territory in accordance with the terms and conditions of this Agreement, which agreement may be granted or withheld at AMAG’s sole discretion. If AMAG so agrees, then the 3SBio Proposed Indication shall be a “Co-Developed Indication.” If AMAG does not so agree, then 3SBio shall have no rights to Develop, seek Regulatory Approval of or Commercialize the Product in such 3SBio Proposed Indication without the prior written consent of AMAG, which may be granted or withheld at AMAG’s sole discretion. With respect to each Co-Developed Indication, the Parties shall prepare a comprehensive development plan describing the activities to be conducted by the Parties to Develop and (B) promptly after receiving such Regulatory Approval, ICN shall notify Schering of ICN's aggregate costs and expenses incurred in pursuing seek Regulatory Approval for such indication, and Schering shall reimburse ICN for such costs and expenses within 45 days after receipt of an invoice from ICN. Schering shall have the right to audit such costs and expenses in accordance with the provisions of Section 6.10(b).
(ii) If ICN does not provide such notice to Schering or if Schering declines to exercise such rights, then ICN shall be free to pursue such indication without further obligation to Schering, except as expressly provided under this Agreement; provided, however, that (i) ICN shall not sell the Product for any such indication in any country in the Territory until five years after the date of the first commercial sale in such country by Schering of the Product for the chronic hepatitis C indicationCo-Developed Indication in the Licensed Territory under this Agreement, and a Budget for all such activities (each, an “Additional Indication Development Plan”). Unless the JSC has earlier been notified pursuant to this Section 3.3, AMAG shall notify the JSC of each Product (as defined in Section 1.54(b)) for which AMAG has submitted an MAA to the FDA for the Initial Indication or any Co-Developed Indication, within sixty (60) days after the later of (i) such submission or (ii) ICN the adoption of the applicable Co-Developed Indication under this Section 3.3. Promptly after such notification, the Parties shall not sublicense any third party prepare amendments to develop, make, have made, use, sell or distribute the Product applicable Development Plan to include Development activities for such indication in such countries Product and shall only sell submit such amendments to the JSC for approval. Unless the JSC determines otherwise, the allocation of activities and expenses for each Co-Developed Indication and Product shall be as set forth in such countries directly or through its direct or indirect subsidiariesSections 3.4 and 3.7. From time to time, either Party may submit to the JSC for discussion any proposed modifications to an Additional Indication Development Plan, and the JSC shall discuss such proposed modifications at its next meeting, and any such modification will become effective only under upon approval by the brand name for the Product which ICN is then using for the hepatitis C indicationJSC as provided in Section 2.2.
Appears in 1 contract
Sources: Collaboration and Exclusive License Agreement (Amag Pharmaceuticals Inc.)
Additional Indications. In further recognition (a) Either Party may propose to the JSC any time during the Term to Develop a product containing or comprising the Licensed Compound for an Additional Indication by presenting a synopsis of additional clinical and technical development activities, the proposed roles of the Parties that ICN's in the development studies phase, the contemplated timeline and the estimated cost of Development. If LICENSEE makes such proposal, LICENSOR shall, through the JSC, consider such proposal in good faith. Further, LICENSOR shall use Commercially Reasonable Efforts to conduct and support the Development accordingly with respect to other indications of any Additional Indication that the Product should not interfere with the development activities conducted by Schering with respect Parties mutually agree to the chronic hepatitis C indication, if ICN pursues an additional indication for the Product in any country in the Territory, then (subject to compliance with Section 3.1(f) in the case of a hepatitis C indication):pursue.
(ib) ICN may so notify Schering by providing Schering with If the JSC decides to Develop a description of ICN's development activitiesproduct containing or comprising the Licensed Compound for an Additional Indication, all associated preclinical the JDC and clinical data, ICN's aggregate costs JTSC shall amend the Clinical Development Plan and expenses incurred in pursuing such development activities to datethe Technical Development Plan accordingly, and the estimated costs and expenses for remaining activitiesall Development activities shall be pursued in accordance with Article 3, and such other information as Schering may reasonably request. In such event, Schering LICENSEE shall have the right, exercisable by notice exclusive right to ICN given not later than 75 days after receipt of the notice from ICN, to elect to have Commercialize such indication become included in and subject to the terms and conditions of this Agreement (including without limitation, those relating to territory and royalties), and all definitions shall be appropriately adjusted to include product for such additional indication, effective upon receipt by ICN of Regulatory Approval with respect to such indication in any country Additional Indication in the Licensed Territory. If Schering exercises such right, then .
(Ac) Schering shall assume and be responsible for any and all further development activities with respect to such indication in accordance with the terms and conditions of this Agreement, and (B) promptly after receiving such Regulatory Approval, ICN shall notify Schering of ICN's aggregate costs and expenses incurred in pursuing Regulatory Approval for such indication, and Schering shall reimburse ICN for such costs and expenses within 45 days after receipt of an invoice from ICN. Schering Each Party shall have the right to audit request appropriate delays in submitting applications with regulatory authorities for any new Additional Indication if reasonably necessary to safeguard the agreed timeline and technical quality of developing indications that are earlier pursued, including, without limitation, Initial Indications. Any such costs request shall be submitted to the JSC for its review and expenses determination.
(d) In case LICENSEE proposes the Development of a product containing or comprising the Licensed Compound in an IV formulation for an Additional Indication and the JSC fails to reach an agreement to pursue such Development for LICENSOR’s denial of its representatives’ consent, LICENSEE shall have the right to Develop or have Developed such product either in cooperation between the Parties at shared cost of Development to be agreed or, failing such an agreement, independently at its own cost and expense for the Development in accordance with the provisions of Section 6.10(b2.2.1(c).
(ii) If ICN does not provide . In such notice to Schering or if Schering declines to exercise case, while such rights, then ICN product for Additional Indications shall be free to pursue such indication without further obligation to Scheringconsidered as Licensed Products for accounting and Milestone and Royalty Payment purposes, except as expressly provided under this Agreement; providedthe Parties shall agree on fair and balanced adjustments of Milestone Payments or Royalty Payments duly taking into account and reflecting the amount of Development costs paid by each Party and the allocation of Development activities between the Parties, however, that (i) ICN shall not sell the Product for any such indication in any country in the Territory until five years after the date of the first commercial sale in such country by Schering of the Product for the chronic hepatitis C indication, and (ii) ICN shall not sublicense any third party to develop, make, have made, use, sell or distribute the Product each case for such indication in such countries and shall only sell the Product in such countries directly or through its direct or indirect subsidiaries, and only under the brand name for the Product which ICN is then using for the hepatitis C indicationAdditional Indication.
Appears in 1 contract
Additional Indications. In further recognition (a) At any time during the Co-Promotion Period, Micromet may submit to the Steering Committee a written proposal to add to the Serono Program any Indication from the list of Additional Indications that is not then included in the Serono Program. If the Steering Committee approves the inclusion of such Indication in the Serono Program, then the Serono Program Plan will be updated to include the Development Activities to be performed by the Parties that ICN's development studies in connection with respect to other indications such Indication. If the Steering Committee does not approve the inclusion of any such Indication in the Product should not interfere with the development activities conducted by Schering with respect Serono Program (each such Indication, a “Rejected Indication”), then, notwithstanding anything in this Agreement to the chronic hepatitis C indicationcontrary, if ICN pursues an additional indication for the Product in any country in the Territory, then (subject to compliance with Section 3.1(f) in the case of a hepatitis C indication):
(i) ICN may so notify Schering by providing Schering with a description of ICN's development activities, all associated preclinical and clinical data, ICN's aggregate costs and expenses incurred in pursuing such development activities to date, and the estimated costs and expenses for remaining activities, and such other information as Schering may reasonably request. In such event, Schering shall Micromet will have the right, exercisable by notice at its own option and expense, to ICN given not later than 75 days after receipt plan and conduct the development of the notice from ICN, to elect to have Product for each such indication become included in and subject to the terms and conditions of this Agreement (including without limitation, those relating to territory and royalties), and all definitions shall be appropriately adjusted to include such additional indication, effective upon receipt by ICN of Regulatory Approval with respect to such indication in any country in the Territory. If Schering exercises such right, then (A) Schering shall assume and be responsible for any and all further development activities with respect to such indication in accordance with the terms and conditions of this Agreement, and (B) promptly after receiving such Regulatory Approval, ICN shall notify Schering of ICN's aggregate costs and expenses incurred in pursuing Regulatory Approval for such indication, and Schering shall reimburse ICN for such costs and expenses within 45 days after receipt of an invoice from ICN. Schering shall have the right to audit such costs and expenses in accordance with the provisions of Section 6.10(b).
(ii) If ICN does not provide such notice to Schering or if Schering declines to exercise such rights, then ICN shall be free to pursue such indication without further obligation to Schering, except as expressly provided under this AgreementRejected Indication; provided, however, that (i) ICN shall Micromet may not sell conduct development of the Product for more than [***] Rejected Indications simultaneously; and provided further, however, that Micromet may not conduct development of the Product for any Rejected Indication if such indication in any country Indication has not been approved pursuant to Section 2.1.5 for inclusion in the Territory until five years after Serono Program based on a determination made in good faith, on the date basis of substantiated medical or scientific rationale, that conducting the development of the first commercial sale Product for such Indication could present safety issues that could compromise the Serono Program. Micromet agrees and acknowledges that if and for so long as the Product is being developed as part of the Serono Program for the [***].
(b) As Serono is responsible following the completion of the Micromet Program for conducting meetings and discussions related to the Product with regulatory authorities, including the FDA, Micromet will not, in the course of developing the Product for a Rejected Indication, conduct any such country meetings or discussions without Serono’s participation or its prior written consent, which consent will not be unreasonably withheld. In addition, Micromet will not send any written materials to the FDA or any other regulatory authority regarding the Product unless such written materials have been reviewed and approved by Schering Serono, which approval will not be unreasonably withheld. If Micromet receives any written or oral communications from the FDA or any other regulatory authority relating to the Product, Micromet will promptly notify Serono and provide a copy to Serono of any written *** 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. communication, or notes of any oral communication. The Parties will confer regarding any response to such written or oral communication prior to its transmission by Serono to the FDA or other regulatory authority. Micromet will provide to Serono any safety data resulting from any clinical trials conducted of the Product in the Rejected Indication in accordance with Applicable Law and the safety reporting and data exchange agreement executed by the Parties pursuant to Section 3.8. Serono will be responsible pursuant to such safety reporting and data exchange agreement for reporting safety data to the FDA or other regulatory authorities.
(c) At any time during which Micromet is developing the Product for a Rejected Indication, Micromet will provide to Serono a copy of any INDs, any interim analyses and final reports of clinical trials performed of the Product for such Rejected Indication, and will otherwise provide updates at the meetings of the Project Team and Steering Committee regarding the development of the Product for the chronic hepatitis C indicationRejected Indication, and including a detailed description of the development costs incurred by Micromet to date with respect to such development. Serono will have the right, not more than [***], to review source data of the clinical trials of the Product for the Rejected Indication that are available to Micromet. Micromet will conduct any clinical studies of the Product in the Rejected Indication in compliance in all material respects with all Applicable Laws including GCP. Serono may at any time during the period Micromet is developing the Product for a Rejected Indication elect to include such Rejected Indication as part of the Serono Program. Upon such election, (i) the Serono Program Plan will be updated to include the Development Activities to be performed by the Parties in connection with such Indication; (ii) ICN shall not sublicense Micromet will transfer to Serono any third party to developclinical data, makeregulatory filings including INDs, and any other Know-How, materials, or data that have been made, use, sell conceived or distribute developed during the development of the Product for the Rejected Indication in an orderly fashion and in a manner such that the value of the delivered information and materials is preserved in all material respects; (iii) Micromet will assign or sublicense to Serono any Technology Acquisition Agreement entered into by Micromet pursuant to Section 6.3.1 with respect to the development of the Product for such indication Rejected Indication; (iv) Serono will [***]; (v) such Indication will cease to be a Rejected Indication; and (vi) Serono will [***].
(d) If Micromet has completed all Pivotal Trials of the Product in such countries and shall only sell a Rejected Indication that, as reasonably determined in good faith in accordance with the decision making processes set forth in Section 2.1.5, are required to support Marketing Approval for the Product in such countries directly or through its direct or indirect subsidiariesRejected Indication, then such Indication will cease to be a Rejected Indication and will be deemed included in the Serono Program, and only under Micromet will transfer to Serono any clinical data and any other Know-How, materials, or data that have been made, conceived or developed during the brand name development of the Product for the Rejected Indication in an orderly fashion and in a manner such that the value of the delivered information and materials is preserved in all material respects. Micromet will also assign or sublicense to Serono any Technology Acquisition Agreement entered into by Micromet pursuant to Section 6.3.1 with *** 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. respect to the development of the Product for such Rejected Indication. Serono will thereafter prepare and file a BLA or MAA for the Product which ICN in such Rejected Indication. Within [***] days of acceptance of such BLA or MAA by the relevant regulatory authority, Serono will [***], and [***]. The Parties will update the marketing plan developed pursuant to Section 5 to include such Rejected Indication and will Commercialize the Product for such Rejected Indication under the terms of this Agreement.
(e) If the BI Process Development Agreement and the BI Process License Agreement have been assigned to Serono or Serono is then using manufacturing Clinical Trial Materials, Serono will supply to Micromet Clinical Trial Materials required by Micromet for the hepatitis C indicationdevelopment of any Rejected Indication [***]. Serono will use commercially reasonable efforts to ensure that capacity is available at a Serono manufacturing facility or a BI manufacturing facility to meet the foregoing obligation, provided that in the event of any capacity limitations, the supply of Clinical Trial Materials for the performance of the Serono Program or Product for the Commercialization of the Product will take precedence over the supply of Clinical Trial Materials required by Micromet for the development of such Rejected Indications.
Appears in 1 contract
Sources: Collaboration and License Agreement (Micromet, Inc.)
Additional Indications. In further recognition by the Parties that ICN's development studies with respect to other indications of the Product should not interfere with the development activities conducted by Schering with respect to the chronic hepatitis C indication, if ICN pursues an additional indication for the Product in any country in the Territory, then (subject to compliance with Section 3.1(f) in the case of a hepatitis C indication):
(i) ICN may so notify Schering by providing Schering with a description of ICN's development activities, all associated preclinical and clinical data, ICN's aggregate costs and expenses incurred in pursuing such development activities to date, and the estimated costs and expenses for remaining activities, and such other information as Schering may reasonably request. In such event, Schering shall have the right, exercisable by notice to ICN given not later than 75 days [REDACTED] after receipt of the notice from ICN, to elect to have such indication become included in and subject to the terms and conditions of this Agreement (including without limitation, those relating to territory and royalties), and all definitions shall be appropriately adjusted to include such additional indication, effective upon receipt by ICN of Regulatory Approval with respect to such indication in any country in the Territory. If Schering exercises such right, then (A) Schering shall assume and be responsible for any and all further development activities with respect to such indication in accordance with the terms and conditions of this Agreement, and (B) promptly after receiving such Regulatory Approval, ICN shall notify Schering of ICN's aggregate costs and expenses incurred in pursuing Regulatory Approval for such indication, and Schering shall reimburse ICN for such costs and expenses within 45 days [REDACTED] after receipt of an invoice from ICN. Schering shall have the right to audit such costs and expenses in accordance with the provisions of Section 6.10(b).
(ii) If ICN does not provide such notice to Schering or if Schering declines to exercise such rights, then ICN shall be free to pursue such indication without further obligation to Schering, except as expressly provided under this Agreement; provided, however, that (i) ICN shall not sell the Product for any such indication in any country in the Territory until five years after the date of the first commercial sale in such country by Schering of the Product for the chronic hepatitis C indication, and (ii) ICN shall not sublicense any third party to develop, make, have made, use, sell or distribute the Product for such indication in such countries and shall only sell the Product in such countries directly or through its direct or indirect subsidiaries, and only under the brand name for the Product which ICN is then using for the hepatitis C indication.
Appears in 1 contract
Sources: Exclusive License and Supply Agreement (Icn Pharmaceuticals Inc)
Additional Indications. In further recognition by the Parties that ICN's development studies with respect to other indications of the Product should not interfere with the development activities conducted by Schering with respect to the chronic hepatitis C indication, if ICN pursues an additional indication for the Product in any country in the Territory, then (subject to compliance with Section 3.1(f) in the case of a hepatitis C indication):
): (i) ICN may so notify Schering by providing Schering with a description of ICN's development activities, all associated preclinical and clinical data, ICN's aggregate costs and expenses incurred in pursuing such development activities to date, and the estimated costs and expenses for remaining activities, and such other information as Schering may reasonably request. In such event, Schering shall have the right, exercisable by notice to ICN given not later than 75 days after receipt of the notice from ICN, to elect to have such indication become included in and subject to the terms and conditions of this Agreement (including without limitation, those relating to territory and royalties), and all definitions shall be appropriately adjusted to include such additional indication, effective upon receipt by ICN of Regulatory Approval with respect to such indication in any country in the Territory. If Schering exercises such right, then (A) Schering shall assume and be responsible for any and all further development activities with respect to such indication in accordance with the terms and conditions of this Agreement, and (B) promptly after receiving such Regulatory Approval, ICN shall notify Schering of ICN's aggregate costs and expenses incurred in pursuing Regulatory Approval for such indication, and Schering shall reimburse ICN for such costs and expenses within 45 days after receipt of an invoice from ICN. Schering shall have the right to audit such costs and expenses in accordance with the provisions of Section 6.10(b).
(ii) If ICN does not provide such notice to Schering or if Schering declines to exercise such rights, then ICN shall be free to pursue such indication without further obligation to Schering, except as expressly provided under this Agreement; provided, however, that (i) ICN shall not sell the Product for any such indication in any country in the Territory until five years after the date of the first commercial sale in such country by Schering of the Product for the chronic hepatitis C indication, and (ii) ICN shall not sublicense any third party to develop, make, have made, use, sell or distribute the Product for such indication in such countries and shall only sell the Product in such countries directly or through its direct or indirect subsidiaries, and only under the brand name for the Product which ICN is then using for the hepatitis C indication.
Appears in 1 contract
Sources: Exclusive License and Supply Agreement (Icn Pharmaceuticals Inc)