Common use of Diligence Clause in Contracts

Diligence. After the exercise of the Inhaled Option or Liquidia Respiratory Option, as applicable, GSK shall use Commercially Reasonable Efforts to develop and seek Regulatory Approval in the Territory, for the Liquidia Respiratory Product and Research Products in the applicable Exercised Field(s). Without limiting the foregoing, if GSK exercises the Inhaled Option and fails to initiate any Clinical Trial on at least [***] Research Product in Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. the Inhaled Field within six (6) years after the Effective Date (such event, a “Development Delay”), GSK shall provide Liquidia with a written explanation of the Development Delay for the applicable Research Products. If the Development Delay was not caused solely or primarily for valid scientific reasons (which would include issues with respect to safety and efficacy as well as delays due to feedback from Regulatory Authorities, whether related to the PRINT Material used in the Research Product or the GSK Material contained in the Research Product), then Liquidia shall have the right, but not the obligation, to convert the Inhaled License to a non-exclusive license upon written notice to GSK; provided, that conversion of the Inhaled License to non-exclusive shall be Liquidia’s sole and exclusive remedy in the event of a Development Delay and Liquidia shall not have the right to terminate this Agreement in accordance with Section 15.3; and provided, further that if the Development Delay is caused by the failure of Liquidia or its contract manufacturer to provide GSK with its required supply of PRINT Materials or Research Products then Liquidia shall not have the right to convert the Inhaled License to non-exclusive. In addition, and notwithstanding anything to the contrary, GSK’s obligation to use Commercially Reasonable Efforts is agreed by the Parties to be dependent upon GSK’s timely receipt of GSK’s requirements of viable PRINT Materials or Research Products that meet all applicable specifications agreed to by the Parties and/or Liquidia’s third party contract manufacturer. Any failure to timely deliver PRINT Materials or Research Products to GSK as described above by Liquidia or a third party contract manufacturer, and any subsequent delays or modifications to GSK’s development plans with respect to any Research Product resulting from such failure to supply shall not be deemed to be GSK’s failure to use Commercially Reasonable Efforts under this Section 6.2.

Appears in 5 contracts

Sources: Inhaled Collaboration and Option Agreement (Liquidia Technologies Inc), Inhaled Collaboration and Option Agreement (Liquidia Technologies Inc), Inhaled Collaboration and Option Agreement (Liquidia Technologies Inc)

Diligence. After the exercise of the Inhaled Option or Liquidia Respiratory Option, as applicable, GSK shall Licensee agrees to use Commercially Reasonable Efforts to develop diligently Develop, Manufacture and seek Regulatory Approval Commercialize the Product in the Territory, Territory for the Liquidia Respiratory Product and Research Products use in the applicable Exercised Field(s)Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, if GSK exercises the Inhaled Option and fails to initiate any Clinical Trial on at least [***] Research Product in Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. the Inhaled Field within six (6) years after the Effective Date (such event, a “Development Delay”), GSK shall provide Liquidia with a written explanation of the Development Delay for the applicable Research Products. If the Development Delay was not caused solely or primarily for valid scientific reasons (which would include issues with respect to safety and efficacy as well as delays due to feedback from Regulatory Authorities, whether related to the PRINT Material used in the Research Product or the GSK Material contained in the Research Product), then Liquidia shall have the right, but not the obligation, to convert the Inhaled License to a non-exclusive license upon written notice to GSK; provided, that conversion of the Inhaled License to non-exclusive shall be Liquidia’s sole and exclusive remedy in the event of a Development Delay and Liquidia shall not have the right to terminate this Agreement in accordance with Section 15.3; and provided, further that if the Development Delay is caused by the failure of Liquidia or its contract manufacturer to provide GSK with its required supply of PRINT Materials or Research Products then Liquidia shall not have the right to convert the Inhaled License to non-exclusive. In addition, and notwithstanding anything to the contrary, GSK’s obligation to Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts is agreed to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Parties to be dependent upon GSK’s timely receipt of GSK’s Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of viable PRINT Materials or Research Products that meet Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all applicable specifications agreed to by work done and results achieved in connection with its Development efforts in the Parties and/or Liquidia’s third party contract manufacturer. Any failure to timely deliver PRINT Materials or Research Products to GSK as described above by Liquidia or a third party contract manufacturer, and any subsequent delays or modifications to GSK’s development plans with respect to any Research Product resulting from such failure to supply shall not be deemed to be GSK’s failure to form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under this Section 6.2all Applicable Laws.

Appears in 5 contracts

Sources: License, Development and Commercialization Agreement (Syndax Pharmaceuticals Inc), License, Development and Commercialization Agreement (Syndax Pharmaceuticals Inc), License, Development and Commercialization Agreement (Syndax Pharmaceuticals Inc)

Diligence. After the exercise of the Inhaled Option or Liquidia Respiratory Option, as applicable, GSK Sanofi shall use Commercially Reasonable Efforts to develop Commercialize the LX4211 Product in the Major Markets in the Territory for T1DM and seek T2DM, following receipt of Regulatory Approval in the Territory, for the Liquidia Respiratory Product and Research Products applicable indication in the applicable Exercised Field(s). Without limiting the foregoing, country; provided that if GSK Lexicon exercises the Inhaled Option and fails to initiate any Clinical Trial on at least [***] Research Product in Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934(Co-)Promotion Right, as amended. the Inhaled Field within six (6) years after the Effective Date (such event, a “Development Delay”), GSK shall provide Liquidia with a written explanation of the Development Delay for the applicable Research Products. If the Development Delay was not caused solely or primarily for valid scientific reasons (which would include issues with respect to safety and efficacy as well as delays due to feedback from Regulatory Authorities, whether related to the PRINT Material used in the Research Product or the GSK Material contained in the Research Product), then Liquidia shall have the right, but not the obligation, to convert the Inhaled License to a non-exclusive license upon written notice to GSK; provided, that conversion of the Inhaled License to non-exclusive shall be Liquidia’s sole and exclusive remedy in the event of a Development Delay and Liquidia shall not have the right to terminate this Agreement in accordance with Section 15.3; and provided, further that if the Development Delay is caused by the failure of Liquidia or its contract manufacturer to provide GSK with its required supply of PRINT Materials or Research Products then Liquidia shall not have the right to convert the Inhaled License to non-exclusive. In addition, and notwithstanding anything to the contrary, GSKSanofi’s obligation to use Commercially Reasonable Efforts is agreed by shall not extend to the Parties responsibilities allocated to Lexicon under the (Co-)Promotion Agreement and applicable T1DM Commercialization Plan; provided further Sanofi shall be dependent upon GSK’s timely receipt of GSK’s requirements of viable PRINT Materials or Research Products that meet all applicable specifications agreed to by the Parties and/or Liquidia’s third party contract manufacturer. Any failure to timely deliver PRINT Materials or Research Products to GSK as described above by Liquidia or a third party contract manufacturer, and any subsequent delays or modifications to GSK’s development plans with respect to any Research Product resulting excused from such failure obligation to supply the extent Lexicon fails to perform its obligations on which Sanofi’s performance depends. If Lexicon exercises the (Co-)Promotion Right, Lexicon shall not use Commercially Reasonable Efforts to perform its obligations in the United States under the T1DM Commercialization Plan. Without limiting Sanofi’s obligations hereunder, Sanofi shall promptly notify Lexicon of any decision to cease using Commercially Reasonable Efforts to Commercialize any Licensed Product in any Major Market in the Territory. Lexicon acknowledges and agrees that nothing in this Section 4.2 is intended, or shall be construed, to require Sanofi to Commercialize more than one Licensed Product at any given time or to Commercialize any other Licensed Product other than the LX4211 Product. If Sanofi implements and uses Commercially Reasonable Efforts to carry out its responsibilities under the T1DM Commercialization Plan pursuant to Section 4.3, Sanofi shall be deemed to be GSK’s failure have satisfied its obligation to use Commercially Reasonable Efforts under this Section 6.24.2 and shall have no liability resulting from any failure of the activities described in the T1DM Commercialization Plan.

Appears in 2 contracts

Sources: Collaboration and License Agreement (Lexicon Pharmaceuticals, Inc.), Collaboration and License Agreement (Lexicon Pharmaceuticals, Inc.)

Diligence. After 4.2.1 Subject to the exercise terms of this Agreement, BI shall use its Commercially Reasonable Efforts to progress the Non-clinical and Clinical Development of the Inhaled Licensed Vaccines and Licensed Products in accordance with the respective Development Plans, including the Development Plan attached hereto as Exhibit 4.2 and as modified and amended by the JSC from time to time in accordance with Section 8 below ("CV9202 Development Plan") and to Commercialize the Licensed Products in the Territory, provided, however that Development activities listed in the CV9202 Development Plan under the heading "Life Cycle Management" shall be at Bl’s sole discretion. Notwithstanding the foregoing, after First Commercial Sale of the first Licensed Product in a Major Market Country the JSC shall discuss and decide whether such Licensed Product will be Developed in a second and/or third indication. If the JSC decides to Develop such Licensed Product in a second and/or third indication, the Parties shall amend the respective Development Plan and Bl’s diligence obligations will be increased so that BI shall use its Commercially Reasonable Efforts to also progress the Non-clinical and Clinical Development of such second and/or third indication. The Development Plans are to set forth, inter alia, (a) the Development work (including CMC Development) to be performed by BI and by CureVac under and during the term of this Agreement; (b) the activities to be performed by CureVac to support the Non-clinical and Clinical Development as further specified in Section 4.1 above; (c) the Clinical Trials to be performed for each clinical phase, including (i) the Clinical Trials to be performed for the Afatinib Vaccine; and (ii) the Clinical Trials to be performed for the Chemo-Radiation Vaccine; and (d) the time estimated for each Clinical Trial. 4.2.2 In the event BI exercises its option under Article 3 above, BI shall promptly prepare a Development Plan for the Option Vaccine, such Development Plan to meet the criteria set forth under Section 4.2.1 above, coordinate such Development Plan for approval within the JSC, and use its Commercially Reasonable Efforts to progress the Non-clinical and Clinical Development of the Option Vaccine and any Licensed Product containing such Option Vaccine in accordance with the Development Plan, and to Commercialize such Licensed Product in the Territory. For the avoidance of doubt, the diligence obligations under Section 4.2.4 below shall also apply to the Option Vaccine in the event BI exercises such option. 4.2.3 BI shall initiate the clinical development with CV9202 of: (a) [*****]; and (b) [*****], and not terminate or Liquidia Respiratory Optionhalt the Non-clinical and Clinical Development unless there are substantial and reasonable technical, safety, efficacy and/or regulatory reasons for doing so, and details of such technical safety, efficacy and/or regulatory have been notified to CureVac in writing through the JSC. EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT CONFIDENTIAL 4.2.4 The diligence obligations set forth above include the following specific activities: BI shall (a) use its Commercially Reasonable Efforts, subsequent to the respective positive Phase I and Phase II Clinical Trials referenced in Section 4.2.3 above, to initiate Phase III Clinical Trials regarding the Licensed Vaccines; (b) conduct all Non-clinical and Clinical Development activities in a timely manner and allocate such Development budgets as applicableare reasonable and adequate to progress the Non-clinical and Clinical Development of Licensed Vaccines hereunder; (c) when appropriate based on satisfactory data obtained during the Non-clinical and Clinical Development, GSK use its Commercially Reasonable Efforts to secure all required Regulatory Approvals in the Major Market Countries following completion of all appropriate Clinical Trials; and (d) use its Commercially Reasonable Efforts to make the First Commercial Sale of the Licensed Products in each Major Market Country following the issuance of the Regulatory Approvals as well as pricing and reimbursement approvals (if any). For the avoidance of doubt, the specific diligence obligations under (a) to (d) shall not apply outside of the Major Market Countries. 4.2.5 The Parties agree that Bl will assume all of CureVac’s rights and obligations (Vertragsubernahme) under the collaboration agreement between CureVac, the Cancer Research Institute and the L▇▇▇▇▇ Institute for Cancer Research (the Cancer Research Institute and the L▇▇▇▇▇ Institute for Cancer Research collectively "LICR") entered into as of October 21, 2013 ("LICR Collaboration Agreement"), and CureVac shall use Commercially Reasonable Efforts to develop procure LICR’s consent thereto. BI will use Commercially Reasonable Efforts and seek Regulatory Approval in the Territory, for the Liquidia Respiratory Product and Research Products in the applicable Exercised Field(s). Without limiting the foregoing, if GSK exercises the Inhaled Option and fails collaborate with LICR to initiate any Clinical Trial on at least [***] Research Product in Confidential treatment has been requested with respect **], provided, however, that BI is not obliged to portions of this agreement as indicated by “(a) [*****]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. the Inhaled Field within six ; or (6b) years after the Effective Date (such event, a “Development Delay”), GSK shall provide Liquidia perform studies with a written explanation commercially available [*****]. For purposes of this Agreement, any data and information generated by the Development Delay for the applicable Research Products. If the Development Delay was LICR in such combination trials and not caused solely or primarily for valid scientific reasons (which would include issues with respect to safety and efficacy as well as delays due to feedback from Regulatory Authorities, whether related to the PRINT Material used in the Research Product or the GSK Material contained in the Research Product), then Liquidia public domain shall have the right, but not the obligation, be considered Confidential Information of BI. BI will grant and hereby grants to convert the Inhaled License to CureVac a non-exclusive license upon written notice to GSK; any such Confidential Information generated by the LICR and Controlled by BI with respect to the [*****] for CureVac to use such Confidential Information in support and promotion of its RNActive technology for any purposes other than the Licensed Vaccines, provided, however, that conversion (i) CureVac shall disclose such Confidential Information to a Third Party solely under an appropriate confidentiality agreement with such Third Party and (ii) prior to such disclosure to a Third Party CureVac shall send to BI the Confidential Information CureVac wishes to disclose and CureVac agrees to withhold disclosure of same for the time necessary to permit BI to obtain optimum patent protections such time period not to exceed [*****] except as required for coordination of such patent protection with Bl’s collaboration partners other than CureVac. CureVac shall comply with Bl's request to withhold disclosure for the time necessary to permit BI to obtain optimum patent protection. In the event CureVac is, despite its Commercially Reasonable Efforts, unable to transfer its rights and obligations regarding the Licensed Vaccines under the LICR Collaboration Agreement to BI, CureVac will exercise the LICR Collaboration Agreement with respect to the Licensed Vaccines upon the direction of BI and BI shall refund any payments to be made to LICR and any costs incurred by CureVac under the collaboration with LICR with respect to the Licensed Vaccines to CureVac. EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT CONFIDENTIAL 4.2.6 Subject to Section 6.3 below, CureVac shall use its Commercially Reasonable Efforts to progress the CMC Development of the Inhaled License to non-exclusive shall be Liquidia’s sole and exclusive remedy in the event of a Development Delay and Liquidia shall not have the right to terminate this Agreement Licensed Vaccines in accordance with Section 15.3; the respective Development Plans for the Licensed Products. In particular, CureVac shall conduct all CMC Development activities in a timely manner and provided, further that if allocate such budgets as are reasonable and adequate to progress the CMC Development of Licensed Vaccines at CureVac hereunder in accordance with the Development Delay is caused by the failure of Liquidia or Plans. Upon CureVac's request, BI shall use its contract manufacturer to provide GSK with its required supply of PRINT Materials or Research Products then Liquidia shall not have the right to convert the Inhaled License to non-exclusive. In addition, and notwithstanding anything to the contrary, GSK’s obligation to use Commercially Reasonable Efforts is agreed to support CureVac in the CMC Development by providing any information and/or documentation required by CureVac for the Parties to be dependent upon GSK’s timely receipt of GSK’s requirements of viable PRINT Materials or Research Products that meet all applicable specifications agreed to by the Parties and/or Liquidia’s third party contract manufacturer. Any failure to timely deliver PRINT Materials or Research Products to GSK as described above by Liquidia or a third party contract manufacturer, and any subsequent delays or modifications to GSK’s development plans with respect to any Research Product resulting from such failure to supply shall not be deemed to be GSK’s failure to use Commercially Reasonable Efforts under this Section 6.2CMC Development.

Appears in 2 contracts

Sources: Exclusive Collaboration and License Agreement (CureVac B.V.), Exclusive Collaboration and License Agreement (CureVac B.V.)

Diligence. (a) After the exercise Effective Date, subject to MedImmune’s retained rights under Section 2.4.1 and to Section 3.3.3, and except as set forth in Section 3.3.1(d), as between the Parties, Licensee shall be solely responsible for all aspects of the Inhaled Option Development of Licensed Compounds and Licensed Products in the Field in the Territory at Licensee’s own cost and expense, including (i) obtaining any quantities of the AstraZeneca Product required for Licensee’s Development activities from commercially available channels; (ii) identifying and engaging a contract research organization or Liquidia Respiratory Optionother vendor to perform testing of Licensed Compound drug substance or drug product; and (iii) sourcing an assay reagent for the performance of stability assays. *** CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, as applicableMARKED BY [***], GSK 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. (b) Licensee shall use Commercially Reasonable Efforts to develop Develop, and seek obtain and maintain Regulatory Approvals for, Licensed Products for use in the Field (x) in the United States, China and the Major European Countries and (y) in other countries throughout the Territory where it is commercially reasonable (consistent with the definition of Commercially Reasonable Efforts) to do so; provided that, in the case of any other country covered by clause (y), Licensee shall not be required pursuant to this sentence to Develop or obtain Regulatory Approval in the Territory, for the Liquidia Respiratory Product and Research Products in the applicable Exercised Field(s). Without limiting the foregoing, if GSK exercises the Inhaled Option and fails to initiate any Clinical Trial on at least [***] Research a Licensed Product in Confidential treatment has been requested such country if the reasonably expected period of exclusivity for such Licensed Product in such country (whether by virtue of an anticipated Valid Claim of a Licensed Patent or the Regulatory Exclusivity Period with respect to portions which the Licensed Product is expected to be eligible upon receipt of this agreement Regulatory Approval or other available data or similar exclusivity) is less than five (5) years assuming the exercise of Commercially Reasonable Efforts to Develop, and obtain and maintain Regulatory Approval for, such Licensed Product in such country. For clarity, the Parties acknowledge that Developing, and obtaining and maintaining Regulatory Approvals for, Licensed Products for use in the Field in the United States and the Major European Countries is a higher timing priority in Licensee’s global development strategy than Developing, and obtaining and maintaining Regulatory Approvals for, Licensed Products for use in the Field in China, and that, accordingly, the use of Commercially Reasonable Efforts to perform such activities in (i) the U.S. and the Major European Countries, on the one hand, and (ii) China, on the other hand, does not require that such activities in China be conducted on the same or similar timeline as indicated such activities in the U.S. and the Major European Countries. (c) In the event that Licensee achieves First Commercial Sale of a Licensed Product in the United States, a Major European Country or China on or before December 31, 2021, Licensee shall so notify MedImmune in writing and provide supporting documentation with respect thereto and the commencement of the Royalty Term shall be delayed until July 1, 2022. (d) Without limitation to the last sentence of Section 2.5.1, upon Licensee’s request, MedImmune shall (or shall cause its applicable Affiliates to) use commercially reasonable efforts to supply Licensee or its designee those quantities of existing ticagrelor active metabolite (AR-C124910XX) on the terms and conditions set forth on Schedule 3.3.1(d) for Licensee’s use in analytical assay development with respect to the Licensed Compounds and Licensed Products. (e) If Licensee elects, including pursuant to the first sentence of Section 3.3.1(b), not to Develop or seek or obtain Regulatory Approval for a Licensed Product, or to Commercialize a Licensed Product in any country or jurisdiction in the Territory where the AstraZeneca Product is being developed or commercialized by or on behalf of MedImmune or its Affiliates or its or their (sub)licensees or successors and the applicable Regulatory Authority conditions the marketing or sale of the AstraZeneca Product on the availability of a Licensed Product, Licensee shall promptly notify MedImmune in writing of such election, and, upon MedImmune’s request, the Parties shall discuss in good faith the terms and *** CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission , 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. conditions pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. the Inhaled Field within six (6) years after the Effective Date (such event, a “Development Delay”), GSK shall provide Liquidia with a written explanation of the Development Delay for the applicable Research Products. If the Development Delay was not caused solely or primarily for valid scientific reasons (which would include issues with respect to safety and efficacy as well as delays due to feedback from Regulatory Authorities, whether related to the PRINT Material used in the Research Product or the GSK Material contained in the Research Product), then Liquidia shall have MedImmune may obtain the right, but not the obligation, to convert the Inhaled License to a non-exclusive license upon written notice to GSK; provided, that conversion of the Inhaled License to non-exclusive shall be Liquidia’s sole Develop or obtain Regulatory Approval for and exclusive remedy Commercialize such Licensed Product in the event of a Development Delay and Liquidia shall not have the right to terminate this Agreement in accordance with Section 15.3; and provided, further that if the Development Delay is caused by the failure of Liquidia such country or its contract manufacturer to provide GSK with its required supply of PRINT Materials or Research Products then Liquidia shall not have the right to convert the Inhaled License to non-exclusive. In addition, and notwithstanding anything to the contrary, GSK’s obligation to use Commercially Reasonable Efforts is agreed by the Parties to be dependent upon GSK’s timely receipt of GSK’s requirements of viable PRINT Materials or Research Products that meet all applicable specifications agreed to by the Parties and/or Liquidia’s third party contract manufacturer. Any failure to timely deliver PRINT Materials or Research Products to GSK as described above by Liquidia or a third party contract manufacturer, and any subsequent delays or modifications to GSK’s development plans with respect to any Research Product resulting from such failure to supply shall not be deemed to be GSK’s failure to use Commercially Reasonable Efforts under this Section 6.2jurisdiction.

Appears in 2 contracts

Sources: License Agreement (PhaseBio Pharmaceuticals Inc), License Agreement (PhaseBio Pharmaceuticals Inc)

Diligence. After 4.5.1 Geron shall use Commercially Reasonable Efforts to perform the activities set forth in the Clinical Development Plan with respect to a Licensed Product containing ANG1005. Geron shall have an obligation to use Commercially Reasonable Efforts to develop and commercialize only one Licensed Product, and for so long as Geron is using Commercially Reasonable Efforts to develop and commercialize a Licensed Product containing ANG1005, this diligence obligation shall be satisfied. If, despite the exercise of Commercially Reasonable Efforts to perform the Inhaled Option activities set forth in the Clinical Development Plan, Geron, its Affiliates and Sublicensees cease the development or Liquidia Respiratory Optioncommercialization of a Licensed Product containing ANG1005 (as demonstrated by (a) written notice by Geron to AngioChem that it has ceased such development, as applicableor (b) the cessation, GSK by Geron, its Affiliates and Sublicensees of the allocation of funds, personnel or other resources to the continued development or commercialization of a Licensed Product containing ANG1005 in accordance with the Clinical Development Plan for a period of two (2) consecutive Calendar Quarters), then Geron shall use Commercially Reasonable Efforts to develop and seek Regulatory Approval commercialize a Further Licensed Product, including the provision of a research plan to AngioChem as specified in Section 4.3.2 within thirty (30) days after delivery of notice by Geron under subclause (a) of this Section, or the Territoryend of two (2) consecutive Calendar Quarters of inactivity as described in subclause (b) of this Section. The obligations of Geron with respect to any Licensed Product under this Section 4.5 are expressly conditioned upon the continuing absence of any adverse condition or event relating to the safety or efficacy of the Licensed Product, and the obligation of Geron to develop or market any such Licensed Product shall be delayed or suspended so long as any such condition or event exists. If such an adverse condition or event arises, Geron shall promptly inform AngioChem upon becoming aware of such adverse condition or event, and the Parties shall make reasonable efforts to promptly (and in any event within twenty (20) business days) convene a JDC meeting. At such JDC meeting, Geron shall provide the JDC with the details of such adverse condition or event and a description of actions planned by Geron in good faith to resolve the cause of such delay or suspension. 4.5.2 In the event that (i) Geron, its Affiliates and Sublicensees cease the development or commercialization of a Licensed Product containing ANG1005 (as demonstrated by (a) written notice by Geron to AngioChem that it has ceased such development, or (b) the cessation, by Geron, its Affiliates and Sublicensees of the allocation of funds, personnel or other resources to the continued development or commercialization of a Licensed Product containing ANG1005 in accordance with the Clinical Development Plan for a period of two (2) consecutive Calendar Quarters), and (ii) either (x) Geron fails to deliver a research plan as specified in Section 4.3.2 for a Further Licensed Product within thirty (30) days after such notice or cessation; or (y) Geron delivers such plan, but Geron, its Affiliates and Sublicensees cease the Liquidia Respiratory development or commercialization of a Further Licensed Product (as demonstrated by (a) written notice by Geron to AngioChem that it has ceased such development, or (b) the cessation, by Geron, its Affiliates and Research Sublicensees of the allocation of funds, personnel or other resources to the continued development or commercialization of such Further Licensed Product in accordance with such research plan for a period of two (2) consecutive Calendar Quarters), and does not deliver a research plan as specified in Section 4.3.2 for another Further Licensed Product within thirty (30) days after such notice or cessation, then AngioChem may terminate this Agreement on written notice to Geron, and subject to Section 10.2.2, Section 4.5.3 shall apply. 4.5.3 (i) If, despite its exercise of Commercially Reasonable Efforts to develop a Licensed Product as set forth in Section 4.5.1, Geron elects to terminate this Agreement pursuant to Section 10.3 and Geron is not in material breach of this Agreement, or (ii) if AngioChem elects to terminate this Agreement as set forth in Section 4.5.2 and provided that AngioChem is not in material breach of this Agreement (provided that any dispute as to whether either Party is or is not in material breach of this Agreement shall be subject to arbitration under Section 12.6), the licenses granted by Geron in Section 2.4 shall survive, and Geron shall, upon request by AngioChem made within one hundred eighty (180) days after the Section 4.5.3 End Date (as defined below), and subject to (a) the terms and conditions of this Agreement, (b) sublicenses granted to any Sublicensees whose sublicense survives termination in accordance with Section 10.4.4, and (c) any other non-exclusive license or option rights granted by Geron as of the effective date of termination, (x) grant to AngioChem an exclusive, worldwide license to develop and commercialize Licensed Products in the applicable Exercised Field(s)Field, including the right to grant sublicenses, under all Patent Rights that claim a Licensed Product (or any component thereof) and Know-How Controlled by Geron (including, without limitation, Geron’s interest in Joint Intellectual Property) necessary or actually used by Geron at the time of termination for the research, development and/or commercialization of Licensed Products (or any component thereof) as single agents, in the Field, (y) shall promptly transfer to AngioChem data, regulatory filings and technology as set forth in Section 10.4.2, and (z) comply with the provisions of Section 10.3 with respect to human clinical trials. Without limiting In consideration of the foregoing grant of license and transfer of data, regulatory filings and technology by Geron to AngioChem, Geron shall be entitled to receive royalties in the amount of * percent (*%) of Net Sales of Licensed Products by AngioChem, its Affiliates and any sublicensees of AngioChem or its Affiliates greater than * dollars (U.S.$*) in any Calendar Year, until such time as Geron has received an amount (the “Reimbursement Amount”) determined by the following formula: * Within sixty (60) days following the Section 45.3 End Date, Geron will advise AngioChem of Geron’s calculation of the Reimbursement Amount, together with reasonable supporting details. If AngioChem disputes such calculation, the matter will be resolved pursuant to Section 11.6. Notwithstanding the foregoing, if GSK exercises if, prior to termination under this Section 4.5.3, the Inhaled Parties have executed a written amendment to this Agreement setting forth mutually acceptable economic terms payable under this Agreement after exercise by Geron of the Buy-Out/Buy-Down Option pursuant to Section 3.5.1, then no payment shall be due by AngioChem to Geron for the grant of the license and fails to initiate any Clinical Trial transfer of data, regulatory filings and technology under this Section 4.5.3, including, without limitation, payment of the Reimbursement Amount. ____________________ * Certain information on at least [***] Research Product in this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. the Inhaled Field within six (6) years after the Effective Date (such event, a “Development Delay”), GSK shall provide Liquidia with a written explanation of the Development Delay for the applicable Research Products. If the Development Delay was not caused solely or primarily for valid scientific reasons (which would include issues with respect to safety and efficacy as well as delays due to feedback from Regulatory Authorities, whether related to the PRINT Material used in the Research Product or the GSK Material contained in the Research Product), then Liquidia shall have the right, but not the obligation, to convert the Inhaled License to a non-exclusive license upon written notice to GSK; provided, that conversion of the Inhaled License to non-exclusive shall be Liquidia’s sole and exclusive remedy in the event of a Development Delay and Liquidia shall not have the right to terminate this Agreement in accordance with Section 15.3; and provided, further that if the Development Delay is caused by the failure of Liquidia or its contract manufacturer to provide GSK with its required supply of PRINT Materials or Research Products then Liquidia shall not have the right to convert the Inhaled License to non-exclusive. In addition, and notwithstanding anything to the contrary, GSK’s obligation to use Commercially Reasonable Efforts is agreed by the Parties to be dependent upon GSK’s timely receipt of GSK’s requirements of viable PRINT Materials or Research Products that meet all applicable specifications agreed to by the Parties and/or Liquidia’s third party contract manufacturer. Any failure to timely deliver PRINT Materials or Research Products to GSK as described above by Liquidia or a third party contract manufacturer, and any subsequent delays or modifications to GSK’s development plans with respect to any Research Product resulting from such failure to supply shall not be deemed to be GSK’s failure to use Commercially Reasonable Efforts under this Section 6.2omitted portions.

Appears in 1 contract

Sources: Exclusive License Agreement (Geron Corp)

Diligence. After 3.1.1 From and after the exercise Licence Agreement Effective Date Amgen shall: (a) use diligent and timely efforts to satisfactorily complete Research of Licensed Antibody Products and obtain in [*] for a Licensed Antibody Product an IND. For the Inhaled Option or Liquidia Respiratory Optionavoidance of doubt, as applicable, GSK nothing in this Licence Agreement shall preclude Amgen from filing INDs in [*]; (b) use Commercially Reasonable Efforts to develop and seek Regulatory Approval in the Territory, for the Liquidia Respiratory Product and Research Products in the applicable Exercised Field(s). Without limiting the foregoing, if GSK exercises the Inhaled Option and fails to initiate any Clinical Trial on at least [***] Research Product in Confidential treatment has been requested satisfactorily complete all Development activities with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. the Inhaled Field within six a Licensed Antibody Product; and (6c) years after the Effective Date (such event, a “Development Delay”), GSK shall provide Liquidia with a written explanation of the Development Delay for the applicable Research Products. If the Development Delay was not caused solely or primarily for valid scientific reasons (which would include issues with respect to safety and efficacy as well as delays due to feedback from Regulatory Authorities, whether related to the PRINT Material used in the Research Product or the GSK Material contained in the Research Product), then Liquidia shall have the right, but not the obligation, to convert the Inhaled License to a non-exclusive license upon written notice to GSK; provided, that conversion of the Inhaled License to non-exclusive shall be Liquidia’s sole and exclusive remedy in the event of a Development Delay and Liquidia shall not have the right to terminate this Agreement in accordance with Section 15.3; and provided, further that if the Development Delay is caused by the failure of Liquidia or its contract manufacturer to provide GSK with its required supply of PRINT Materials or Research Products then Liquidia shall not have the right to convert the Inhaled License to non-exclusive. In addition, and notwithstanding anything to the contrary, GSK’s obligation to use Commercially Reasonable Efforts to obtain Regulatory Approval to Commercialise a Licensed Antibody Product; in each case for the [*] or if the [*] is agreed by the Parties to be dependent upon GSK’s timely receipt of GSK’s requirements of viable PRINT Materials or Research Products that meet all applicable specifications agreed to by the Parties and/or Liquidia’s third party contract manufacturer. Any failure to timely deliver PRINT Materials or Research Products to GSK as described above by Liquidia or a third party contract manufacturerdropped, and any subsequent delays or modifications to GSK’s development plans with respect to any Research Product resulting from such failure to supply shall not be deemed to be GSK’s failure to [*]; and (d) use Commercially Reasonable Efforts to maximise Net Sales of each Licensed Antibody Product in the Territory. For the avoidance of doubt, the Parties acknowledge that the diligence obligations may have been met, in whole or in part, by activity conducted under the Collaboration Agreement. 3.1.2 Amgen acknowledges that using Commercially Reasonable Efforts requires it to take ongoing actions that are consistent with a good faith intention to achieve the objective of Developing a Licensed Antibody Product and obtaining Regulatory Approvals to Commercialise such Licensed Antibody Product for the [*] (or if the [*] is dropped, [*]) in the Field, and to Commercialise such Licensed Antibody Product [*]. For the avoidance of doubt, Development and Commercialisation in each instance includes the manufacture and supply of Licensed Antibody Product. If Amgen decides that deployment of Commercially Reasonable Efforts does not justify it making continued, ongoing efforts towards this objective it shall promptly notify Celltech in writing. 3.1.3 Amgen shall not be in breach of any obligation under this Section 6.2.Licence Agreement to the extent its inability to perform such obligation is caused by Celltech's failure to perform any of its obligations under this Licence Agreement or under Article 14.9

Appears in 1 contract

Sources: Collaboration and License Agreement (Amgen Inc)

Diligence. After In the exercise event Monsanto Canada exercises the Call Option and either acquires all of the Inhaled Option outstanding capital stock of Licensee or Liquidia Respiratory Optionreceives from Licensee an assignment of all of Licensee’s rights and obligations under this Agreement then, following such acquisition or assignment, the following provisions shall apply: (a) Subject to Section 2.6(c) below, during the period of time beginning upon termination of Protiva’s obligation to provide the Services, as applicableset forth in Section 4.4 below, GSK and ending on the expiration of the 10-year period following Commercial Launch of the first Product or earlier date of payment to Protiva pursuant to Section 3.3(a) below (the “Diligence Period”), Licensee shall use Commercially Reasonable Efforts commercially reasonable efforts to develop Develop, Manufacture, and seek Regulatory Approval Commercialize a Product. (b) Whether certain efforts by Licensee are deemed to be “commercially reasonable” for purposes of this Section 2.6 shall be determined in light of all relevant factors in all of the relevant jurisdictions in the Territory, taken as a whole, including but not limited to: the perceived market potential of any Product (including anticipated or actual profit margin); the anticipated level of regulatory approval that may be available for such Product (including any restrictions on the use thereof); the level of intellectual property protection of such Product; the presence of third-party intellectual property that may impact the marketability of such Product (including any claims made or threatened by third parties that the manufacture, marketing or sale of such Product infringes, violates or misappropriates the intellectual property of such third parties); the presence or absence of particularly difficult manufacturing issues; and the expected competitive position of such Product vis-à-vis other products that may have been or may be developed, marketed and sold for the Liquidia Respiratory Product and Research Products in the applicable Exercised Field(s). Without limiting the foregoingsame or similar use, if GSK exercises the Inhaled Option and fails to initiate any Clinical Trial on at least [***] Research Product in Confidential treatment has been requested including with respect to portions the expected or actual efficacy and cost of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant Product when compared to Rule 24b-2 of the Securities Exchange Act of 1934, as amendedsuch other products. the Inhaled Field within six (6) years after the Effective Date (such event, a “Development Delay”), GSK shall provide Liquidia with a written explanation of the Development Delay for the applicable Research Products. If the Development Delay was not caused solely or primarily for valid scientific reasons (which would include issues with respect to safety and efficacy as well as delays due to feedback from Regulatory Authorities, whether related to the PRINT Material used in the Research Product or the GSK Material contained in the Research Product), then Liquidia shall have the right, but not the obligation, to convert the Inhaled License to a non-exclusive license upon written notice to GSK; provided, that conversion of the Inhaled License to non-exclusive shall be Liquidia’s sole and exclusive remedy in the event of a Development Delay and Liquidia shall not have the right to terminate this Agreement in accordance with Section 15.3; and provided, further that if the Development Delay is caused by the failure of Liquidia or its contract manufacturer to provide GSK with its required supply of PRINT Materials or Research Products then Liquidia shall not have the right to convert the Inhaled License to non-exclusive. In addition, and notwithstanding anything to the contrary, GSK’s obligation to use Commercially Reasonable Efforts is agreed by the Parties to be dependent upon GSK’s timely receipt of GSK’s requirements of viable PRINT Materials or Research Products that meet all applicable specifications agreed to by the Parties and/or Liquidia’s third party contract manufacturer. Any failure to timely deliver PRINT Materials or Research Products to GSK as described above by Liquidia or a third party contract manufacturer, and any subsequent delays or modifications to GSK’s development plans with respect to any Research Product resulting from such failure to supply Licensee shall not be deemed to be GSKin breach of this Section 2.6(b) for any particular period unless Licensee’s failure efforts with respect to use Commercially Reasonable Efforts Products during such period, taken as a whole, or in combination with efforts in prior periods, taken as a whole, are not commercially reasonable. (c) Licensee may terminate its obligations under this Section 6.22.6 at any time prior to the expiration of the Diligence Period, effective immediately upon payment to Protiva of an amount equal to [***] (the “Diligence Buyout Payment”). In addition, upon such payment, Protiva’s rights and Licensee’s obligations under Section 3.3 shall terminate and, in no event, shall any payments be made to Protiva pursuant to Section 3.3(a). The amount of the Diligence Buyout Payment shall be reduced, if applicable, in accordance with Monsanto’s right of set off and/or any reduction in the amount of the Diligence Buyout Payment as a result of a Change of Control of Protiva or Tekmira, in each case under the Option Agreement.

Appears in 1 contract

Sources: License and Services Agreement (TEKMIRA PHARMACEUTICALS Corp)

Diligence. After During the exercise applicable Term for a given Product and subject to the terms and conditions of the Inhaled Option or Liquidia Respiratory Optionthis Agreement, as applicable, GSK DURA shall use Commercially Reasonable Efforts commercially reasonable efforts to develop (i) distribute, market, sell, and seek Regulatory Approval promote such Product within the Territory and (ii) create and maintain a market for and to increase the sales of Products in the Territory. In the performance of such obligations, DURA shall: 3.1.1 use commercially reasonable efforts to maintain and provide at its expense an organization of qualified, professional salespersons as set forth in Section 3.2; 3.1.2 maintain and provide at its expense suitable storage in accordance with the Specifications and labeling and other appropriate facilities and services reasonably satisfactory to BMS, as needed for the Liquidia Respiratory storage and continuous sale and distribution of Products within the Territory; 3.1.3 use commercially reasonable efforts to solicit new customers and to maintain existing customers for the Products; 3.1.4 use commercially reasonable efforts to ensure that sufficient stock of each Product will be available in its inventory to fill orders from the trade in accordance with normal industry practices, including maintaining reasonable levels of inventory in light of customary industry practice and Research historical sales patterns; 3.1.5 use commercially reasonable efforts to conduct at its expense appropriate promotional activities for the Product sufficient for DURA to achieve adequate and reasonably rapid market penetration; 3.1.6 provide, at its expense, an adequate Product traceability system (e.g. lot level traceability, readily accessible format), reasonably satisfactory to BMS; 3.1.7 ensure that its sales force personnel do not make representations or claims with respect to the safety, efficacy or uses for a Product that are not contained within such Product's applicable Product Registration and/or labeling and/or that are not permitted by applicable law; 3.1.8 market and sell Products only on the basis of quality, service, price and other legitimate marketing attributes, and without the payment of bribes or any similar inducements; 3.1.9 observe and perform all provisions of this Agreement, and comply with all pertinent laws and regulations in force in the Territory; and 3.1.10 use commercially reasonable efforts not to take any action which would have a material adverse impact on (i) the commercialization of the Products in the applicable Exercised Field(s). Without limiting Territory or (ii) the foregoingthen existing business of BMS, if GSK exercises the Inhaled Option its Affiliates and fails to initiate any Clinical Trial on at least [***] Research Product in Confidential treatment has been requested licensees with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 Products in other countries of the Securities Exchange Act of 1934, world (taken as amended. the Inhaled Field within six (6) years after the Effective Date (such event, a “Development Delay”whole), GSK shall provide Liquidia with a written explanation of the Development Delay for the applicable Research Products. If the Development Delay was not caused solely or primarily for valid scientific reasons (which would include issues with respect to safety and efficacy as well as delays due to feedback from Regulatory Authorities, whether related to the PRINT Material used in the Research Product or the GSK Material contained in the Research Product), then Liquidia shall have the right, but not the obligation, to convert the Inhaled License to a non-exclusive license upon written notice to GSK; provided, that conversion of the Inhaled License to non-exclusive shall be Liquidia’s sole and exclusive remedy in the event of a Development Delay and Liquidia shall not have the right to terminate this Agreement in accordance with Section 15.3; and provided, further that if the Development Delay is caused by the failure of Liquidia or its contract manufacturer to provide GSK with its required supply of PRINT Materials or Research Products then Liquidia shall not have the right to convert the Inhaled License to non-exclusive. In addition, and notwithstanding anything to the contrary, GSK’s obligation to use Commercially Reasonable Efforts is agreed by the Parties to be dependent upon GSK’s timely receipt of GSK’s requirements of viable PRINT Materials or Research Products that meet all applicable specifications agreed to by the Parties and/or Liquidia’s third party contract manufacturer. Any failure to timely deliver PRINT Materials or Research Products to GSK as described above by Liquidia or a third party contract manufacturer, and any subsequent delays or modifications to GSK’s development plans with respect to any Research Product resulting from such failure to supply shall not be deemed to be GSK’s failure to use Commercially Reasonable Efforts under this Section 6.2.

Appears in 1 contract

Sources: Distribution Agreement (Dura Pharmaceuticals Inc)

Diligence. After the exercise of the Inhaled Option or Liquidia Respiratory Option, as applicable, GSK CASI shall use Commercially Reasonable Efforts to develop (a) Develop the Licensed Product according to the CASI Development Plan and seek Regulatory Approval (b) Develop the Licensed Product in the Territory, for the Liquidia Respiratory Product and Research Products in the applicable Exercised Field(s). Without limiting the foregoing, if GSK exercises the Inhaled Option and fails to initiate any Clinical Trial on at least [***] Research Product Indications in Confidential treatment has been requested with respect to portions of this agreement as indicated the Territory, which shall be selected by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission CASI pursuant to Rule 24b-2 Section 4.1(c) or Section 4.1(d). CASI shall maintain and utilize qualified staff, laboratories, offices and other facilities as needed to Develop the Licensed Product and shall use personnel with skills and experience as may be required to accomplish efficiently and expeditiously such tasks and objectives of the Securities Exchange Act of 1934CASI Development Plan in a good scientific manner and in compliance in all material respects with all Applicable Laws, and cGLP, cGCP and cGMP standards, as amendedapplicable. CASI shall, as part of its obligations hereunder (i) obtain all required Regulatory Authority and ethic committee and independent review board approvals prior to conducting any Clinical Trials involving human subjects and (ii) obtain all the Inhaled Field consents required by Applicable Law from the human subjects participating in any Clinical Trials conducted by CASI. In particular, with regards to the first Indication, CASI shall achieve the milestones set out in Exhibit D. Any anticipated failure to achieve any such milestones shall be discussed within six (6) years after the Effective Date (JSC, which has the authority, pursuant to Section 3.2, to adjust such event, a “milestone in the 22 ​ CASI Development Delay”), GSK shall provide Liquidia with a written explanation Plan. Each of the Development Delay deadlines for the applicable Research Products. If Development milestones provided above will be extended by the duration of any delays that are encountered during the course of Development Delay was not and caused solely or primarily for valid scientific reasons by events outside of the control of CASI, including: (which would include issues with respect to safety and efficacy as well as delays due to feedback from Regulatory Authorities, whether related a) Force majeure; (b) An Adverse Event reported pursuant to the PRINT Material used Safety and Pharmacovigilance Agreement; (c) Unforeseen bona fide regulatory delays; (d) Any delay by BioInvent in completing the Research Product or the GSK Material contained in the Research Product), then Liquidia shall have the right, but not the obligation, to convert the Inhaled License to a non-exclusive license upon written notice to GSK; provided, that conversion of the Inhaled License to non-exclusive shall be Liquidia’s sole and exclusive remedy in the event of a Development Delay and Liquidia shall not have the right to terminate this Agreement Initial Technology Transfer in accordance with Section 15.3; 4.3(a); (e) Any delay by BioInvent in achieving its covenant set forth in and provided, further that if the Development Delay is caused in accordance with Section 11.2(n); (f) Any delay by the BioInvent in achieving its covenant set forth in and in accordance with Section 11.2(p); (g) The failure of Liquidia BioInvent or its contract manufacturer Third Party licensees or sublicensees to provide GSK fulfill its obligations under this Agreement or to supply the required Licensed Products to CASI with its required supply of PRINT Materials or Research Products then Liquidia shall not have timelines provided in the right to convert the Inhaled License to non-exclusive. In additionSupply Agreement with such failure resulting in a ▇▇▇▇ ▇▇▇▇▇; (h) Any extension agreed upon in writing by both Parties, and notwithstanding anything for example, coincidentally with an amendment to the contraryCASI Development Plan; and (i) Any other event that caused an actual delay for which CASI is not responsible or accountable for (including, GSK’s obligation e.g., changes to use Commercially Reasonable Efforts is agreed by Applicable Laws, requested consultation meetings with the Parties to be dependent upon GSK’s timely receipt of GSK’s requirements of viable PRINT Materials or Research Products that meet all applicable specifications agreed to by Regulatory Authority in the Parties and/or Liquidia’s third party contract manufacturer. Any failure to timely deliver PRINT Materials or Research Products to GSK as described above by Liquidia or Territory, or, if a third party contract manufacturerRegulatory Authority places a BioInvent product on regulatory hold outside the Territory, and any subsequent delays or modifications to GSK’s development plans with respect to any Research Product resulting from such failure to supply shall not be deemed to be GSK’s failure to use Commercially Reasonable Efforts under this Section 6.2in regulatory hold being put in place for CASI in the Territory).

Appears in 1 contract

Sources: License and Development Agreement (CASI Pharmaceuticals, Inc.)

Diligence. After 3.1.1 From and after the exercise Licence Agreement Effective Date Amgen shall: (a) use diligent and timely efforts to satisfactorily complete Research of Licensed Antibody Products and obtain in [*] for a Licensed Antibody Product an IND. For the Inhaled Option or Liquidia Respiratory Optionavoidance of doubt, as applicable, GSK nothing in this Licence Agreement shall preclude Amgen from filing INDs in [*]; (b) use Commercially Reasonable Efforts to develop and seek Regulatory Approval in the Territory, for the Liquidia Respiratory Product and Research Products in the applicable Exercised Field(s). Without limiting the foregoing, if GSK exercises the Inhaled Option and fails to initiate any Clinical Trial on at least [***] Research Product in Confidential treatment has been requested satisfactorily complete all Development activities with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. the Inhaled Field within six a Licensed Antibody Product; and (6c) years after the Effective Date (such event, a “Development Delay”), GSK shall provide Liquidia with a written explanation of the Development Delay for the applicable Research Products. If the Development Delay was not caused solely or primarily for valid scientific reasons (which would include issues with respect to safety and efficacy as well as delays due to feedback from Regulatory Authorities, whether related to the PRINT Material used in the Research Product or the GSK Material contained in the Research Product), then Liquidia shall have the right, but not the obligation, to convert the Inhaled License to a non-exclusive license upon written notice to GSK; provided, that conversion of the Inhaled License to non-exclusive shall be Liquidia’s sole and exclusive remedy in the event of a Development Delay and Liquidia shall not have the right to terminate this Agreement in accordance with Section 15.3; and provided, further that if the Development Delay is caused by the failure of Liquidia or its contract manufacturer to provide GSK with its required supply of PRINT Materials or Research Products then Liquidia shall not have the right to convert the Inhaled License to non-exclusive. In addition, and notwithstanding anything to the contrary, GSK’s obligation to use Commercially Reasonable Efforts to obtain Regulatory Approval to Commercialise a Licensed Antibody Product; in each case for the [*] or if the [*] is agreed by the Parties to be dependent upon GSK’s timely receipt of GSK’s requirements of viable PRINT Materials or Research Products that meet all applicable specifications agreed to by the Parties and/or Liquidia’s third party contract manufacturer. Any failure to timely deliver PRINT Materials or Research Products to GSK as described above by Liquidia or a third party contract manufacturerdropped, and any subsequent delays or modifications to GSK’s development plans with respect to any Research Product resulting from such failure to supply shall not be deemed to be GSK’s failure to [*]; and (d) use Commercially Reasonable Efforts to maximise Net Sales of each Licensed Antibody Product in the Territory. For the avoidance of doubt, the Parties acknowledge that the diligence obligations may have been met, in whole or in part, by activity conducted under the Collaboration Agreement. 3.1.2 Amgen acknowledges that using Commercially Reasonable Efforts requires it to take ongoing actions that are consistent with a good faith intention to achieve the objective of Developing a Licensed Antibody Product and obtaining Regulatory Approvals to Commercialise such Licensed Antibody Product for the [*] (or if the [*] is dropped, [*]) in the Field, and to Commercialise such Licensed Antibody Product [*]. For the avoidance of doubt, Development and Commercialisation in each instance includes the manufacture and supply of Licensed Antibody Product. If Amgen decides that deployment of Commercially Reasonable Efforts does not justify it making continued, ongoing efforts towards this objective it shall promptly notify Celltech in writing. 3.1.3 Amgen shall not be in breach of any obligation under this Section 6.2.Licence Agreement to the extent its inability to perform such obligation is caused by Celltech’s failure to perform any of its obligations under this Licence Agreement or under Article 14.9

Appears in 1 contract

Sources: Collaboration and License Agreement (Amgen Inc)

Diligence. After In the exercise event Monsanto Canada exercises the Call Option and either acquires all of the Inhaled Option outstanding capital stock of Licensee or Liquidia Respiratory Optionreceives from Licensee an assignment of all of Licensee’s rights and obligations under this Agreement then, following such acquisition or assignment, the following provisions shall apply: (a) Subject to Section 2.6(c) below, during the period of time beginning upon termination of Protiva’s obligation to provide the Services, as applicableset forth in Section 4.4 below, GSK and ending on the expiration of the 10-year period following Commercial Launch of the first Product or earlier date of payment to Protiva pursuant to Section 3.3(a) below (the “Diligence Period”), Licensee shall use Commercially Reasonable Efforts commercially reasonable efforts to develop Develop, Manufacture, and seek Regulatory Approval Commercialize a Product. (b) Whether certain efforts by Licensee are deemed to be “commercially reasonable” for purposes of this Section 2.6 shall be determined in light of all relevant factors in all of the relevant jurisdictions in the Territory, taken as a whole, including but not limited to: the perceived market potential of any Product (including anticipated or actual profit margin); the anticipated level of regulatory approval that may be available for such Product (including any restrictions on the use thereof); the level of intellectual property protection of such Product; the presence of third-party intellectual property that may impact the marketability of such Product (including any claims made or threatened by third parties that the manufacture, marketing or sale of such Product infringes, violates or misappropriates the intellectual property of such third parties); the presence or absence of particularly difficult manufacturing issues; and the expected competitive position of such Product vis-à-vis other products that may have been or may be developed, marketed and sold for the Liquidia Respiratory Product and Research Products in the applicable Exercised Field(s). Without limiting the foregoingsame or similar use, if GSK exercises the Inhaled Option and fails to initiate any Clinical Trial on at least [***] Research Product in Confidential treatment has been requested including with respect to portions the expected or actual efficacy and cost of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant Product when compared to Rule 24b-2 of the Securities Exchange Act of 1934, as amendedsuch other products. the Inhaled Field within six (6) years after the Effective Date (such event, a “Development Delay”), GSK shall provide Liquidia with a written explanation of the Development Delay for the applicable Research Products. If the Development Delay was not caused solely or primarily for valid scientific reasons (which would include issues with respect to safety and efficacy as well as delays due to feedback from Regulatory Authorities, whether related to the PRINT Material used in the Research Product or the GSK Material contained in the Research Product), then Liquidia shall have the right, but not the obligation, to convert the Inhaled License to a non-exclusive license upon written notice to GSK; provided, that conversion of the Inhaled License to non-exclusive shall be Liquidia’s sole and exclusive remedy in the event of a Development Delay and Liquidia shall not have the right to terminate this Agreement in accordance with Section 15.3; and provided, further that if the Development Delay is caused by the failure of Liquidia or its contract manufacturer to provide GSK with its required supply of PRINT Materials or Research Products then Liquidia shall not have the right to convert the Inhaled License to non-exclusive. In addition, and notwithstanding anything to the contrary, GSK’s obligation to use Commercially Reasonable Efforts is agreed by the Parties to be dependent upon GSK’s timely receipt of GSK’s requirements of viable PRINT Materials or Research Products that meet all applicable specifications agreed to by the Parties and/or Liquidia’s third party contract manufacturer. Any failure to timely deliver PRINT Materials or Research Products to GSK as described above by Liquidia or a third party contract manufacturer, and any subsequent delays or modifications to GSK’s development plans with respect to any Research Product resulting from such failure to supply Licensee shall not be deemed to be GSKin breach of this Section 2.6(b) for any particular period unless Licensee’s failure efforts with respect to use Commercially Reasonable Efforts Products during such period, taken as a whole, or in combination with efforts in prior periods, taken as a whole, are not commercially reasonable. (c) Licensee may terminate its obligations under this Section 6.22.6 at any time prior to the expiration of the Diligence Period, effective immediately upon payment to Protiva of an amount equal to [Redacted – amount] (the “Diligence Buyout Payment”). In addition, upon such payment, Protiva’s rights and Licensee’s obligations under Section 3.3 shall terminate and, in no event, shall any payments be made to Protiva pursuant to Section 3.3(a). The amount of the Diligence Buyout Payment shall be reduced, if applicable, in accordance with Monsanto’s right of set off and/or any reduction in the amount of the Diligence Buyout Payment as a result of a Change of Control of Protiva or Tekmira, in each case under the Option Agreement.

Appears in 1 contract

Sources: License and Services Agreement (TEKMIRA PHARMACEUTICALS Corp)