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

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

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Diligence. After AbbVie proceeds with the exercise of the Inhaled Option or Liquidia Respiratory OptionIn-Licensing, as applicable, GSK AbbVie shall use Commercially Reasonable Efforts to develop and seek Commercialize a Licensed Product for the Initial Indications in each Major Market following receipt of Regulatory Approval therefor in each such Major Market. For purposes of clarity, AbbVie shall not be obligated to Commercialize more than one (1) Licensed Product or any Licensed Product for more than the TerritoryInitial Indications in any Major Market. Ablynx acknowledges and agrees that, for the Liquidia Respiratory Product and Research Products in the applicable Exercised Field(s). Without limiting addition to the foregoing, if GSK exercises (i) the Inhaled Option Commercialization of Licensed Product may be delayed, suspended or otherwise modified by AbbVie in response to circumstances outside the reasonable control of AbbVie, including force majeure events 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 serious safety and efficacy as well as delays due to feedback from Regulatory Authoritiesissues, whether related to the PRINT Material used in the Research Product or the GSK Material contained in the Research Product), then Liquidia and (ii) AbbVie 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 satisfy its diligence obligations under this Agreement in accordance with Section 15.3; and provided, further that if 4.2 through its Affiliates or Sublicensees. If AbbVie decides to discontinue the Development Delay or Commercialization of a Licensed Compound or Licensed Product in favor of another Licensed Compound or Licensed Product, its obligations under this Section 4.2 shall cease with respect to such initial Licensed Compound or Licensed Product in favor of such other Licensed Compound or Licensed Product. If at any time Ablynx has a reasonable basis to believe that AbbVie is caused by in material breach of its obligations under this Section 4.2, then Ablynx shall so notify AbbVie, specifying the failure of Liquidia or basis for 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 additionbelief, and notwithstanding anything to the contrary, GSK’s obligation to use Commercially Reasonable Efforts is agreed by the Parties shall meet within […***…] after such notice to be dependent upon GSKdiscuss in good faith Ablynx’s timely receipt of GSKconcerns and AbbVie’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 Commercialization 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 6.2the Licensed Product.

Appears in 3 contracts

Samples: Exclusive License Agreement (Ablynx NV), Exclusive License Agreement (Ablynx NV), Exclusive License Agreement (Ablynx NV)

Diligence. After the exercise of the Inhaled Option Anthera, either on its own or Liquidia Respiratory Optionthrough one or more Affiliates or sublicensees, as applicable, GSK shall use Commercially Reasonable Efforts commercially reasonable efforts to develop and seek Regulatory Approval commercialize the Licensed Products commensurate with those efforts commonly used in the Territorybiotechnology industry by reputable biotechnology companies in connection with the development, for the Liquidia Respiratory Product manufacture and Research Products commercialization of a pharmaceutical product of similar market potential, and shall in the applicable Exercised Field(s). Without limiting the foregoing, if GSK exercises the Inhaled Option and fails particular use commercially reasonable efforts to initiate any Clinical Trial on at least within [***] Research Product in Confidential treatment has been requested with respect to portions of this agreement as indicated by “the Effective Date a [***]” and such confidential portions have been deleted and filed separately ] of a Licensed Product. Whether particular development efforts are commercially reasonable shall be measured on a country-by-country basis in accordance with the Securities overall standard set forth in the first sentence of this Section 3.5. Anthera shall keep Amgen advised of all ongoing development 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 manufacturing activities by providing Amgen 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 an annual update report summarizing Anthera’s development and manufacturing activities with respect to safety and Licensed Products (including but not limited to information on all clinical studies involving Licensed Products). Notwithstanding the foregoing, Anthera would not be deemed to have breached such diligence obligations if its development efforts are delayed as a result of events or occurrences that are outside of Anthera’s control (provided Anthera has used commercially reasonable efforts with respect to matters within its control), including the following: (i) any breach of this Agreement by Amgen that adversely affects Anthera’s ability to develop Licensed Products, (ii) regulatory holds or new regulatory requirements, (iii) an event of force majeure, or (iv) a development issue involving safety, toxicity, efficacy as well as delays due or pharmacokinetics, or the ability to feedback from Regulatory Authoritiesscale up manufacturing processes (in each case, whether related to the PRINT Material used extent outside of Anthera’s control, using commercially reasonable efforts). If Amgen reasonably believes that Anthera has breached its diligence obligations under this Agreement in connection with the Research Product development, manufacture 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 commercialization of the Inhaled License Licensed Product, Amgen and Anthera shall meet and agree upon a reasonable plan to non-exclusive minimize the development delay caused by such breach. Amgen 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 pursuant to Section 15.3; 9.2 if Anthera does not initiate within [***] from the date on which the Parties agree to such plan, and provideddiligently continue, further that if efforts under such plan to address and minimize the Development Delay is delay caused by the failure Anthera’s breach of Liquidia or its contract manufacturer diligence obligations 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, GSKAmgen’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 6.2reasonable satisfaction.

Appears in 3 contracts

Samples: License Agreement (Anthera Pharmaceuticals Inc), License Agreement (Anthera Pharmaceuticals Inc), License Agreement (Anthera Pharmaceuticals Inc)

Diligence. After the exercise of the Inhaled Option or Liquidia Respiratory Option, as applicable, GSK shall AVROBIO will use Commercially Reasonable Efforts to develop Develop and seek Regulatory Approval in the Territory, for the Liquidia Respiratory Product and Research Commercialize one or more Licensed Products in the applicable Exercised Field(s)United States and in the Major European Countries. Without In addition, and without limiting the generality of the foregoing, if GSK exercises the Inhaled Option and fails to AVROBIO shall initiate any Clinical Trial on at least an IND-enabling pharmacology/toxicology study of a Licensed Product within [***] 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 amendedEffective Date. 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 In the event that BioMarin believes AVROBIO is in material breach 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 6.23.3, then BioMarin may so notify AVROBIO in writing, which notice shall provide available details regarding the basis for its belief and specifying that such notice (a “Diligence Breach Notice”) is being provided by BioMarin pursuant to this Section 3.3. If a Diligence Breach Notice is provided to AVROBIO, AVROBIO may, within a further period of [***] after receipt of such notice, provide a written report to BioMarin to justify why AVROBIO believes it is not in such material breach of such diligence obligation. If no such report is provided by AVROBIO by the end of such time period, BioMarin shall be permitted to terminate this Agreement pursuant to Section 8.2. If AVROBIO provides a response, the Parties shall then conduct an initial meeting within [***] after delivery of such a written report from AVROBIO to discuss in good faith the concerns raised by BioMarin and shall conduct such additional meetings as are reasonably necessary to reach agreement as to whether or not AVROBIO is in material breach of its obligations under this Section 3.3 for an additional [***] after such initial meeting. If after such [***] period following the initial meeting, the Parties cannot reach agreement then, upon request of either Party, the matter shall be referred to the dispute resolution procedure outlined under Section 11.3, which procedure shall be required to: (a) determine whether there was, in fact, a material breach by AVROBIO of its diligence obligation, and (b) if it is determined that there was an uncured material breach, specify what additional efforts AVROBIO must undertake to cure such breach, and the time period during which such efforts must be commenced and completed (which time period shall be commercially reasonable). If such procedure determines that there was a material *** Confidential Treatment Requested *** breach of the diligence obligation hereunder, and AVROBIO does not commence or complete the cure efforts specified by the arbitration result (in response to the clause (b) requirement above) by the required relevant dates, then BioMarin may terminate the Agreement pursuant to Section 8.2. All efforts of AVROBIO’s Affiliates, Third Party contractors and sublicensees will be considered efforts of AVROBIO for the purpose of determining AVROBIO’s compliance with its obligations under this Section 3.3.

Appears in 3 contracts

Samples: License Agreement (AVROBIO, Inc.), License Agreement (AVROBIO, Inc.), License Agreement (AVROBIO, Inc.)

Diligence. After the exercise of the Inhaled Option or Liquidia Respiratory Option, as applicable, GSK Immune Design shall use Commercially Reasonable Efforts continuing commercially reasonable efforts to develop and seek Regulatory Approval commercialize Licensed GLA Product(s) in the Immune Design Exclusive Field in accordance with its business, legal, medical and scientific judgments, and in undertaking investigations and actions required to obtain appropriate regulatory approval(s) necessary to market such Licensed GLA Product(s) in the Territory, for . If IDRI believes that Immune Design (or its Affiliate or sublicensee) has failed to satisfy 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 diligence obligation under this Section 3.1(c) with respect to initiate any Clinical Trial on at least [***] Research Product , IDRI shall proceed as follows: (i) IDRI shall provide Immune Design with written notice thereof, which notice shall describe the failure and the efforts, in Confidential treatment IDRI’s view, needed to be taken by Immune Design to overcome the failure; (ii) if the Parties are unable to resolve a dispute under this Section 3.1(c) within *** days after the date of IDRI’s notice, either Party shall have the right to refer the matter to arbitration under Section 13.2 to determine if Immune Design has been requested failed to use the commercially reasonable efforts required under this Section 3.1(c) and, if so, what steps need to be taken by Immune Design, and how soon, to satisfy such obligation with respect to portions of this agreement as indicated the Licensed GLA Product identified by “[***]” and such confidential portions have been deleted and filed separately with Immune Design; (iii) if the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934arbitrator determines that Immune Design has not satisfied its obligation, 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 Immune Design shall have the right, but not within the obligationtimeframe determined by the arbitrator, to convert take the Inhaled License steps determined by the arbitrator to a non-exclusive license upon written notice be required to GSKsatisfy such obligation; providedand (iv) if Immune Design does not take such steps within such timeframe (or it is subsequently decided by arbitration in accordance with Section 13.2 that Immune Design has failed to take such steps within such timeframe), 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 IDRI may terminate this Agreement in accordance with Section 15.3; 10.2(b), but without the need for the additional ***-day cure period stated in Section 10.2(b). Termination in accordance with the foregoing procedure shall be IDRI’s sole and provided, further that if the Development Delay is caused by the failure exclusive remedy for breach 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 6.23.1(c). *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

Appears in 2 contracts

Samples: License Agreement (Immune Design Corp.), License Agreement (Immune Design Corp.)

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 exercises the Inhaled Option and fails to initiate any Clinical Trial on at least [***] Research Product in Lexicon Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted materials omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of Commission. Asterisks denote omissions. exercises 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

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

Diligence. After the exercise of the Inhaled Option or Liquidia Respiratory Option, as applicable, GSK AbbVie shall use Commercially Reasonable Efforts to develop Commercialize a Licensed Product [***]; provided that (a) such obligation is expressly conditioned upon Licensor’s and seek Regulatory Approval its Affiliates’ performing their respective obligations hereunder, and (b) such obligation shall be delayed or suspended for as long as any failure by Licensee or its Affiliates to perform their respective obligations hereunder persists; [***]. Licensor acknowledges and agrees that, in the Territory, for the Liquidia Respiratory Product and Research Products in the applicable Exercised Field(s). Without limiting addition to the foregoing, if GSK exercises (a) the Inhaled Option Commercialization of Licensed Product may be delayed, suspended or otherwise modified by AbbVie in response to circumstances outside the reasonable control of AbbVie, including force majeure events, (b) AbbVie shall have the right to satisfy its diligence obligations under this Section 4.3 through its Affiliates or Sublicensees, and fails (c) nothing in this Section 4.3 is intended, or shall be construed, to initiate require AbbVie to Develop or Commercialize a specific Licensed Antibody or Licensed Product. If AbbVie decides to discontinue the development or commercialization of a Licensed Antibody or Licensed Product in favor of another Licensed Antibody or Licensed Product, its obligations under this Section 4.3 shall cease with respect to such initial Licensed Antibody or Licensed Product in favor of such other Licensed Antibody or Licensed Product. If at any Clinical Trial on at least time Licensor has a reasonable basis to believe that AbbVie is in material breach of its material obligations under this Section 4.3, then Licensor may so notify AbbVie, specifying the basis for its belief, and the Parties shall meet within [***] Research Product after such notice to discuss in Confidential treatment has been requested good faith Licensor’s concerns and AbbVie’s Commercialization plans with respect to portions of Licensed Product. *** Certain information in this agreement as indicated by “[***]” and such confidential portions have has been deleted omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of Commission. [***] indicates that text has been omitted and is 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 subject 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 6.2confidential treatment request.

Appears in 2 contracts

Samples: Development and Option Agreement (Alector, Inc.), Development and Option Agreement (Alector, Inc.)

Diligence. After the exercise LICENSEE will, and will cause its Affiliates and each of the Inhaled Option or Liquidia Respiratory Optionits Sublicensees to, as applicable, GSK shall use Commercially Reasonable Efforts to develop and seek Regulatory Approval commercialize Licensed Product(s) in the Territory, for the Liquidia Respiratory Product and Research Products in the applicable Exercised Field(s)Major Markets as soon as practicable. Without limiting the foregoing, if GSK exercises the Inhaled Option and fails to initiate any Clinical Trial Beginning on at least [***] Research Product in Confidential treatment has been requested with respect to portions of this agreement as indicated by “the Agreement Date and continuing [***] until the [***], LICENSEE will, and such confidential portions have been deleted will cause its Affiliates and filed separately with each of its Sublicensees to provide annual summary updates to BCM summarizing the Securities activities undertaken by LICENSEE, its Affiliates and Exchange Commission pursuant each of its Sublicensees to Rule 24b-2 continue the development and commercialization of the Securities Exchange Act Licensed Products. In the event that BCM determines that LICENSEE or its Affiliates and its Sublicensees have not used Commercially Reasonable Efforts to continue the development and commercialization of 1934Licensed Products, as amended. BCM will have the Inhaled Field within six (6) years after the Effective Date (such event, a “Development Delay”), GSK shall right to provide Liquidia with a written explanation request to LICENSEE to provide further written evidence that LICENSEE, its Affiliates and each of its Sublicensees has undertaken continual and regular activities to continue the Licensed Products development and commercialization. In the event that LICENSEE is unable to show that it, its Affiliates and/or each of its Sublicensees have undertaken such continual regular activities to develop and commercialize the Licensed Products, then LICENSEE (on behalf of it and its Affiliates and each of its Sublicensees) will have an obligation to provide a detailed development plan to BCM for the continued development and commercialization of the Development Delay Licensed Products, and would thereafter provide summary updates of activities every [***]. If such activities thereafter continued to show a lack of Commercially Reasonable Efforts for the applicable Research development and commercialization of the Licensed 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 BCM would have the right to terminate this Agreement in accordance with Section 15.3; and provided, further the license. The Parties agree that if they are unable to agree as to whether the Development Delay is caused evidence provided by LICENSEE (on behalf of it and its Affiliates and each of its Sublicensees) shows continual and regular activities to continue the failure of Liquidia or its contract manufacturer Licensed Product development and commercialization, a third-party arbitrator would be jointly retained to provide GSK with its required supply of PRINT Materials or Research Products then Liquidia shall review the evidence and make an independent determination and such determination will be final[***]. Notwithstanding the foregoing, the Parties acknowledge that it might be commercially reasonable, under certain circumstances, for LICENSEE to determine not have the right to convert the Inhaled License to non-exclusive. In additionlaunch a Licensed Product in a specific country, and notwithstanding anything failure under such circumstances 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 launch such Licensed Product resulting from such failure to supply shall not be deemed to be GSK’s failure to use Commercially Reasonable Efforts under a breach of this Section 6.2Agreement.

Appears in 1 contract

Samples: Exclusive License Agreement (Allovir, Inc.)

Diligence. After the AlgoRx shall exercise commercially reasonable efforts to develop, or to license to a Third Party to develop, each 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 AlgoRx Oral Products in the applicable Exercised Field(s). Without limiting the foregoingorder to retain such product as an AlgoRx Oral Product, if GSK exercises the Inhaled Option and fails to initiate any Clinical Trial on shall expend (or its licensee shall expend) at least [***] Research ***** in research and development to support such efforts per AlgoRx Oral Product until Regulatory Approval is achieved; provided that the foregoing shall apply to only one AlgoRx Oral Product in Confidential treatment has been requested a closely-related class of AlgoRx Oral Products that are established by agreement of the Parties as provided at the end of Section 2.4(a), and shall not apply to any of the AlgoRx Oral Products that are based on Pain Drugs. PRL shall exercise commercially reasonable efforts to develop, or to license to a Third Party to develop, each of the PowderJect Oral Products in order to retain such product as an PowderJect Oral Product, and shall expend (or its licensee shall expend) at least ******** in research and development to support such efforts per PowderJect Oral Product until Regulatory Approval is achieved; provided that the foregoing shall apply to only one PowderJect Oral Product in a closely-related class of PowderJect Oral Products that are established by agreement of the Parties as provided at the end of Section 2.4(b). Twelve (12) months after designation of a particular Therapeutic Product as either an AlgoRx Oral Product or a PowderJect Oral Product (and once every subsequent twelve-month period), the designating Party shall provide to the other Party an annual summary of its diligence with respect to portions of such Oral Delivery Product. If, with respect to a particular Oral Delivery Product for which a particular designating Party has obtained exclusive rights in the Oral Delivery Field as provided in this agreement as indicated by “[***]” and Section 2.4, 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 1934Party (or its Affiliate or sublicensee) has, 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 during the applicable Research Productstwelve-month period, expended the required amount of development funds, then the designating Party shall be deemed to have satisfied its diligence obligations under this Section 2.4(c) with respect to such Oral Delivery Product. If the Development Delay was designating Party (or its Affiliate or sublicensee) has not caused solely expended the required amount of development funding on, or primarily for valid scientific reasons (which would include issues with respect is not otherwise continuing to safety and efficacy as well as delays due use commercially reasonable efforts to feedback from Regulatory Authoritiesdevelop, whether related to the PRINT Material used in the Research Product or the GSK Material contained in the Research a particular Oral Delivery Product), then Liquidia designating Party shall cease to have the exclusive rights to such Oral Delivery Product, and the non-designating Party shall have the right, but not the obligation, to convert the Inhaled License to a nonco-exclusive license upon written notice rights to GSK; provided, that conversion of the Inhaled License pursue such product and shall also be free to non-designate such product as its own exclusive shall be Liquidia’s sole and exclusive remedy product in the event Oral Delivery Field under the above terms 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 6.22.4.

Appears in 1 contract

Samples: License Agreement (Algorx Pharmaceuticals Inc)

Diligence. After the exercise of the Inhaled Option or Liquidia Respiratory OptionSubject to Chiesi’s compliance with Section 5.3, as applicable, GSK shall Protalix will use Commercially Reasonable Efforts to develop and carry out the Development Plan in order to Develop the Licensed Product in the Field in the Territory (subject to Section 3.2(d)). Subject to Protalix’s compliance with Section 3.6(c), Chiesi will use Commercially Reasonable Efforts to seek as soon as reasonably practicable Regulatory Approval for the Licensed Product in the Field in the Territory. Chiesi will use Commercially Reasonable Efforts to Launch and Commercialize the Licensed Product in the Territory, promptly following such Regulatory Approval of the Licensed Product in the Field. The previous sentence above notwithstanding, if, prior to the submission of the NDA seeking Regulatory Approval for the Liquidia Respiratory Licensed Product and Research Products in the Territory, Chiesi notifies Protalix in writing of any specific Competing Product Patents that, in Chiesi’s good faith evaluation may pose risks in relation to Chiesi’s Launch of the Licensed Product, and if, within ten (10) Business Days of receiving such written notice, Protalix provides Chiesi with written notice that Protalix desires to jointly engage a law firm to advise regarding the same in accordance with this Section 3.5: (i) Protalix and Chiesi promptly shall jointly engage a law firm of reputable stature and experienced in patent matters related to biologic products and approved by both Parties (such approval not to be unreasonably withheld, conditioned or delayed) to provide its legal opinion as to whether a judge or jury would be highly unlikely to conclude, in exercising its discretion in applying the applicable Exercised Field(sLaws to the facts, that the Launch of the Licensed Product in the Field in the Territory would infringe the Third Party Patent(s) or Patent Application(s) (which the law firm concludes could reasonably be issued within eighteen (18) months of the anticipated Regulatory Approval for the Licensed Product in the Territory) specified in such notice (with each Party paying an equal share of all costs, fees and expenses to be paid to such law firm therefor, and the law firm shall be instructed to try to provide such opinion within sixty (60) days of the engagement), and (ii) in the event that such law firm does not, prior to Regulatory Approval of the Licensed Product in the Field in the Territory, render a legal opinion that a judge or jury would be highly unlikely to conclude, in exercising its discretion in applying the applicable Laws to the facts, that the Launch of the Licensed Product in the Field in the Territory would infringe the Third Party Patent(s) or Patent Application(s) (which the law firm concludes could reasonably be issued within eighteen (18) months of the anticipated Regulatory Approval for the Licensed Product in the Territory) specified in such notice (including where Protalix fails to provide written notice that it desires to jointly engage a law firm in accordance with this Section 3.5), Chiesi will have the ultimate decision-making authority on the timing of the Launch (subject to Section 12.1(f)), based upon Chiesi’s good faith evaluation of any risks associated with such specified Third Party Patents or Patent Applications. Without limiting The Parties acknowledge and agree that (x) all communications with such law firm with respect to 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 “[***]” such law firm’s related work product, and such opinion (the “Privileged Materials”) shall be privileged and confidential portions have been deleted and filed separately with shall not be disclosed to anyone other than the Securities Parties, except that a Party may disclose the Privileged Materials in confidence to a court, tribunal or other authority of competent jurisdiction if reasonably necessary to enforce its rights under this Agreement; provided that such Party seeks the highest level of confidential treatment for such Privileged Materials and Exchange Commission pursuant limits the disclosure to Rule 24b-2 the portion of the Securities Exchange Act of 1934Privileged Material reasonably necessary to enforce its rights under this Agreement, as amended. and (y) prior to engaging the Inhaled Field within six (6) years after law firm, the Effective Date (such eventParties shall enter into a reasonable and customary joint defense agreement or common interest agreement; provided that, 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 Authoritiesavoidance of doubt, 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 enter into such a joint defense agreement 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 common interest agreement shall not be construed or deemed as evidence of any waiver by any of the Parties of any applicable legal privilege or any of its or their rights in this Agreement, or as an indication that an applicable legal privilege has not attached to be GSK’s failure to use Commercially Reasonable Efforts under this Section 6.2any Privileged Materials.

Appears in 1 contract

Samples: License and Supply Agreement (Protalix BioTherapeutics, Inc.)

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Diligence. After the exercise Except as limited by Section 2.4(c), effective as of the Inhaled Option or Liquidia Respiratory OptionEffective Date, as applicableSchering and its Affiliates shall, GSK shall at Schering’s expense, use Commercially Reasonable Efforts commercially reasonable efforts to develop and seek obtain Regulatory Approval for and to commercialize the Product(s) in the Territory, for the Liquidia Respiratory Product and Research Products Field in the applicable Exercised Field(s)Territory for such indications as Schering determines are desirable. Without limiting the foregoing, if GSK exercises the Inhaled Option The Parties acknowledge and fails agree that nothing herein shall be construed as obligating Schering to initiate any Clinical Trial on at least obtain Regulatory Approval for and/or to commercialize more than [***] Research Product in Confidential treatment has been requested with respect the Field in the Territory. The Parties further acknowledge and agree that all business decisions including, without limitation, decisions relating to portions Schering’s research, development, registration, manufacture, sale, commercialization, design, pricing, distribution, marketing and promotion of Products covered under this agreement as indicated by “Agreement, shall be within the sole discretion of Schering. Accordingly, Schering shall be responsible, at its cost and expense, and in its sole judgment, for all activities that are necessary to obtain [***]” ] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Regulatory Approval for the Product and such confidential portions have been deleted any post-approval studies required as a condition of obtaining any Regulatory Approval for the Product in the Field in the Territory. Schering shall also be responsible, at its cost and filed separately with expense, and in its sole judgment, for determining the Securities appropriate regulatory strategy for obtaining and Exchange Commission pursuant to Rule 24b-2 maintaining all Regulatory Approvals, including any pricing and reimbursement approvals required for the sale of the Securities Exchange Act Products in the Field in the Territory. Schering shall own the Business Information, the R&D Results, and all other data and information arising out of 1934any and all studies or other research and development or commercial activities performed by or on behalf of Schering under this Agreement. Each Regulatory Approval, including pricing and reimbursement approvals, shall be owned by and held in the name of Schering or its designated Affiliate. ViroPharma acknowledges that Schering is in the business of developing, manufacturing and selling pharmaceutical products and nothing in this Agreement shall be construed as amended. restricting such business or imposing on Schering 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 duty to market and/or sell and exploit Compound or Products 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 royalties are payable hereunder to the PRINT Material used exclusion of, or in the Research Product preference to, any other 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 any way other than in accordance with its normal commercial practices. The Parties acknowledge and agree that nothing in this Section 15.3; and provided, further that if the Development Delay is caused by the failure of Liquidia 4.2 shall be construed as obligating Schering 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 Affiliates to any Research Product resulting from such failure to supply shall not be deemed to be GSK’s failure to use Commercially Reasonable Efforts greater diligence obligations for the Products in the Territory than those expressly provided for under this Section 6.24.4 of the SaSy Agreement.

Appears in 1 contract

Samples: License Agreement (Viropharma Inc)

Diligence. After the AlgoRx shall exercise commercially reasonable efforts to develop, or to license to a Third Party to develop, each 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 AlgoRx Oral Products in the applicable Exercised Field(s). Without limiting the foregoingorder to retain such product as an AlgoRx Oral Product, if GSK exercises the Inhaled Option and fails to initiate any Clinical Trial on shall expend (or its licensee shall expend) at least [***] Research * in research and development to support such efforts per AlgoRx Oral Product until Regulatory Approval is achieved; provided that the foregoing shall apply to only one AlgoRx Oral Product in Confidential treatment has been requested a closely-related class of AlgoRx Oral Products that are established by agreement of the Parties as provided at the end of Section 2.4(a), and shall not apply to any of the AlgoRx Oral Products that are based on Pain Drugs, PRL shall exercise commercially reasonable efforts to develop, or to license to a Third Party to develop, each of the PowderJect Oral Products in order to retain such product as an PowderJect Oral Product, and shall expend (or its licensee shall expend) at least ***** in research and development to support such efforts per PowderJect Oral Product until Regulatory Approval is achieved; provided that the foregoing shall apply to only one PowderJect Oral Product in a closely-related class of PowderJect Oral Products that are established by agreement of the Parties as provided at the end of Section 2.4(b). Twelve (12) months after designation of a particular Therapeutic Product as either an AlgoRx Oral Product or a PowderJect Oral Product (and once every subsequent twelve-month period), the designating Party shall provide to the other Party an annual summary of its diligence with respect to portions of such Oral Delivery Product. If, with respect to a particular Oral Delivery Product for which a particular designating Party has obtained exclusive rights in the Oral Delivery Field as provided in this agreement as indicated by “[***]” and Section 2.4, 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 1934Party (or its Affiliate or sublicensee) has, 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 during the applicable Research Productstwelve-month period, expended the required amount of development funds, then the designating Party shall be deemed to have satisfied its diligence obligations under this Section 2.4(c) with respect to such Oral Delivery Product. If the Development Delay was designating Party (or its Affiliate or sublicensee) has not caused solely expended the required amount of development funding on, or primarily for valid scientific reasons (which would include issues with respect is not otherwise continuing to safety use commercially reasonable efforts to develop, a particular Oral Delivery Product, men designating Party shall cease to have the exclusive rights to such Oral Delivery Product, 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 non-designating Party shall have the right, but not the obligation, to convert the Inhaled License to a nonco-exclusive license upon written notice rights to GSK; provided, that conversion of the Inhaled License pursue such product and shall also be free to non-designate such product as its own exclusive shall be Liquidia’s sole and exclusive remedy product in the event Oral Delivery Field under the above terms 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 6.22.4.

Appears in 1 contract

Samples: License Agreement (Algorx Pharmaceuticals Inc)

Diligence. After the exercise of the Inhaled Option or Liquidia Respiratory Option, as applicable, GSK LICENSEE shall use Commercially Reasonable Efforts to research, develop and seek Regulatory Approval commercialize a Licensed Product in the Field in the Territory. For purposes of this Section 4.3, for the Liquidia Respiratory Product and Research Products in efforts of LICENSEE’s Related Parties shall also be considered the applicable Exercised Field(s)efforts of LICENSEE. Without limiting the foregoingLICENSEE will be deemed to have demonstrated Commercially Reasonable Efforts if, if GSK exercises the Inhaled Option and fails to initiate any Clinical Trial on at least within [***] Research Product in Confidential treatment years of the Effective Date, LICENSEE has been requested (a) achieved the Additional License Agreements Milestone or (b) established a scientific program, including a research plan and budget, with respect to portions of this agreement as indicated by “a protein-based interleukin-1 antagonist program. Within [***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 ] months of the Securities Exchange Act first to occur of 1934, as amended. the Inhaled Field within six achievement by LICENSEE of either (6a) years after or (b) above and the [**] anniversary of the Effective Date (such eventDate, the Parties will negotiate in good faith and agree upon a set of diligence milestones to be achieved by LICENSEE with respect to the development and commercialization of Licensed Products, which will be included in writing as an Appendix to this Agreement. In the event LICENSEE determines that it is unable to meet, or otherwise fails to meet, a “Development Delay”)diligence milestone, GSK shall LICENSEE will notify LICENSOR in writing and provide Liquidia with a written an explanation of the Development Delay for reasons that the applicable Research Productsdiligence milestone has not or will not be met. If The Parties will promptly negotiate in good faith an amendment to the Development Delay was not caused solely or primarily for valid scientific reasons (diligence milestone which would may include issues a reasonable extension of the time required to achieve the milestone based on the circumstances and LICENSEE’s explanation and an obligation of LICENSEE to provide periodic status reports to LICENSOR with respect to safety its efforts to develop and efficacy commercialize Licensed Products, which amendment will be included as well as delays due to feedback from Regulatory Authorities, whether related an update 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, relevant Appendix 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 6.2Agreement.

Appears in 1 contract

Samples: License Agreement (Eleven Biotherapeutics, Inc.)

Diligence. After the exercise LICENSEE will, and will cause its Affiliates and each of the Inhaled Option or Liquidia Respiratory Optionits Sublicensees to, as applicable, GSK shall use Commercially Reasonable Efforts to develop and seek Regulatory Approval commercialize Licensed Product(s) in the Territory, for Major Markets as soon as practicable. Beginning on 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 “the Agreement Date and continuing [***] until [***], LICENSEE will, and such confidential portions have been deleted will cause its Affiliates and filed separately with each of its Sublicensees to provide annual summary updates to BCM summarizing the Securities activities undertaken by LICENSEE, its Affiliates and Exchange Commission pursuant each of its Sublicensees to Rule 24b-2 continue the development and commercialization of the Securities Exchange Act Licensed Products. In the event that BCM determines that LICENSEE or its Affiliates and its Sublicensees have not used Commercially Reasonable Efforts to continue the development and commercialization of 1934Licensed Products, as amended. BCM will have the Inhaled Field within six (6) years after the Effective Date (such event, a “Development Delay”), GSK shall right to provide Liquidia with a written explanation request to LICENSEE to provide further written evidence that LICENSEE, its Affiliates and each of its Sublicensees has undertaken continual and regular activities to continue the Licensed Products development and commercialization. In the event that LICENSEE is unable to show that it, its Affiliates and/or each of its Sublicensees have undertaken such continual regular activities to develop and commercialize the Licensed Products, then LICENSEE (on behalf of it and its Affiliates and each of its Sublicensees) will have an obligation to provide a detailed development plan to BCM for the continued development and commercialization of the Development Delay Licensed Products, and would thereafter provide summary updates of activities every [***]. If such activities thereafter continued to show a lack of Commercially Reasonable Efforts for the applicable Research development and commercialization of the Licensed 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 BCM would have the right to terminate this Agreement in accordance with Section 15.3; and provided, further the license. The Parties agree that if they are unable to agree as to whether the Development Delay is caused evidence provided by LICENSEE (on behalf of it and its Affiliates and each of its Sublicensees) shows continual and regular activities to continue the failure of Liquidia or its contract manufacturer Licensed Product development and commercialization, a third-party arbitrator would be jointly retained to provide GSK with its required supply of PRINT Materials or Research Products then Liquidia shall review the evidence and make an independent determination and such determination will be final. [***] Notwithstanding the foregoing, the Parties acknowledge that it might be commercially reasonable, under certain circumstances, for LICENSEE to determine not have the right to convert the Inhaled License to non-exclusive. In additionlaunch a Licensed Product in a specific country, and notwithstanding anything failure under such circumstances 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 launch such Licensed Product resulting from such failure to supply shall not be deemed to be GSK’s failure to use Commercially Reasonable Efforts under a breach of this Section 6.2Agreement.

Appears in 1 contract

Samples: Exclusive License Agreement (Allovir, 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 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 Section 4.3.2 within thirty (30) days after delivery of notice by Geron under subclause (a) 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 1934Section, 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 end of the Inhaled License to non-exclusive shall be Liquidia’s sole and exclusive remedy in the event two (2) consecutive Calendar Quarters 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 inactivity as described above by Liquidia or a third party contract manufacturer, and any subsequent delays or modifications to GSK’s development plans in subclause (b) of this Section. The obligations of Geron with respect to any Research Licensed Product resulting from such failure to supply shall not be deemed to be GSK’s failure to use Commercially Reasonable Efforts under this Section 6.24.5 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.

Appears in 1 contract

Samples: Exclusive License Agreement (Geron Corp)

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