Common use of Diligence Obligations Clause in Contracts

Diligence Obligations. 3.8.1 Sionna (itself or through its Affiliates or Sublicensees) shall use Commercially Reasonable Efforts to Develop, obtain Regulatory Approval for, and Commercialize at least [***] of the Licensed Priority Compounds and at least [***] comprising such Licensed Priority Compound in the United States and EU5 in accordance with the Development plan set forth in Schedule 3.3. Notwithstanding the foregoing or the timeline set forth in Schedule 3.3, during the period commencing on the Effective Date and ending [***] months thereafter, ▇▇▇▇▇▇ shall not be in breach of its obligations under this Section 3.8.1 to the extent Sionna (itself or through its Affiliates or Sublicensees) Develops a Sionna Compound to combine with a Licensed Priority Compound in accordance with the development philosophy set forth in Section (a) of Schedule 3.3. 3.8.2 If at any time AbbVie has a reasonable basis to believe that Sionna is in material breach of its diligence obligations with respect to the Development of any Licensed Compounds or Licensed Products under Section 3.8.1, then AbbVie may so notify ▇▇▇▇▇▇ in writing, specifying the basis for its belief, and, without limitation to any other right or remedy available to AbbVie hereunder, at AbbVie’s request, the Parties shall meet within [***] days after such notice to discuss in good faith AbbVie’s concerns and ▇▇▇▇▇▇’s Development plans with respect to such Licensed Compound or Licensed Product. 3.8.3 If at any time AbbVie has a reasonable basis to believe that Sionna is in material breach of its diligence obligations with respect to Commercialization of any Licensed Compound or Licensed Product under Section 3.8.1, then AbbVie may so notify ▇▇▇▇▇▇ in writing, specifying the basis for its belief, and, without limitation to any other right or remedy available to AbbVie hereunder, at AbbVie’s request, the Parties shall meet within [***] days after such notice to discuss in good faith AbbVie’s concerns and ▇▇▇▇▇▇’s Commercialization plans with respect to such Licensed Compound or Licensed Product.

Diligence Obligations. 3.8.1 Sionna (itself or through BMS shall use its best reasonable efforts to develop and market S-K Product(s) for commercial sale and distribution throughout the Territory pursuant to this Agreement, and to such end, BMS, its Affiliates or Sublicensees) its Sub-sublicensees shall use Commercially Reasonable Efforts to Develop, obtain Regulatory Approval for, and Commercialize at least [***] of achieve the Licensed Priority Compounds and at least [***] comprising such Licensed Priority Compound in the United States and EU5 following objectives in accordance with the Development plan following schedule: (i) [XXX]. (ii) [XXX]. The Parties acknowledge that, subject to certain limitations set forth in Schedule 3.3Section 5.01 of the ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇/PROGENICS License Agreement, failure to achieve these objectives shall entitle ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ to terminate the license granted under the ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇/PROGENICS License Agreement and, thereby, the license granted under this Agreement. PROGENICS shall not unreasonably withhold its consent to, and shall use all reasonable efforts to obtain the consent of ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ to, any revision in the preceding schedule requested in writing by BMS and supported by evidence of technical difficulties or delays in the clinical studies or regulatory process that could not have been reasonably avoided. Notwithstanding the foregoing or foregoing, the timeline set forth in Schedule 3.3, during the period commencing on the Effective Date and ending [***] months thereafter, Parties acknowledge that ▇▇▇▇▇-▇▇▇▇▇▇▇▇▇ shall not be in breach of its obligations have the right to terminate the license granted under this Section 3.8.1 to the extent Sionna (itself or through its Affiliates or Sublicensees) Develops a Sionna Compound to combine with a Licensed Priority Compound in accordance with the development philosophy set forth in Section (a) of Schedule 3.3. 3.8.2 If at any time AbbVie has a reasonable basis to believe that Sionna is in material breach of its diligence obligations with respect to the Development of any Licensed Compounds or Licensed Products under Section 3.8.1, then AbbVie may so notify ▇▇▇▇▇▇ in writing, specifying the basis for its belief, and, without limitation to any other right or remedy available to AbbVie hereunder, at AbbVie’s request, the Parties shall meet within [***] days after such notice to discuss in good faith AbbVie’s concerns and -▇▇▇▇▇▇’s Development plans with respect ▇▇▇/PROGENICS License Agreement, and therefore PROGENICS shall not have a right to terminate the license granted under this Agreement, for the failure of BMS to meet a goal if such Licensed Compound or Licensed Product. 3.8.3 If at any time AbbVie has failure is a reasonable basis to believe that Sionna is in material breach result of its diligence obligations with respect to Commercialization of any Licensed Compound or Licensed Product under Section 3.8.1, then AbbVie may so notify (i) causes beyond BMS's direct control; (ii) ▇▇▇▇▇▇ in writing, specifying the basis for its belief, and, without limitation to any other right or remedy available to AbbVie hereunder, at AbbVie’s request, the Parties shall meet within [***] days after such notice to discuss in good faith AbbVie’s concerns and -▇▇▇▇▇▇’s Commercialization plans with respect ▇▇▇'▇ or PROGENICS's failure to such Licensed Compound meet its obligations hereunder; (iii) infringement of Third Party patents; or Licensed Product(iv) actions or inactions of a federal or state agency whose approval is required for commercial sales. The Parties further acknowledge and agree that the milestones contained in this Section 5.1 were established on the assumption that the milestones would apply to development of the GMK Vaccine. In the event that development of the GMK Vaccine is terminated due to safety or efficacy reasons, the parties agree that the milestones set forth in this Section 5.1 shall not apply and the Parties will negotiate in good faith to establish new milestones.

Diligence Obligations. 3.8.1 Sionna (itself a) [***] (b) Without limiting the foregoing, Disc shall, directly on its behalf, or through one or more of its Affiliates or Sublicensees) , Initiate a Phase I Clinical Trial for a Licensed Product in the First Indication in the Licensed Territory by [***]; provided, however, if at any time Disc determines that it is unlikely to meet any such deadline despite using Commercially Reasonable Efforts, Disc shall use notify Mabwell in writing and explain in reasonable detail (other than in the case where a delay results from Mabwell’s, its Affiliate’s or Sublicensee’s action or inaction), the technical or manufacturing challenges, safety or efficacy concerns, supply chain disruptions, patient enrollment difficulties, feedback from a Regulatory Authority or other reasons therefore causing the delay, and in such case, so long as Disc is using Commercially Reasonable Efforts to Developmeet such deadline, obtain such deadline shall be tolled or automatically extended for [***], during which time the Parties shall discuss the resolution of such reasons for any delays, if practicable. Without limiting the foregoing, the deadlines shall be automatically extended by the duration of any delay caused by: [***]. Any further extension of the deadlines, due to reasons other than those set forth in clauses [***], shall require Mabwell’s written approval, which shall not be unreasonably withheld, conditioned or delayed for up to [***]. Notwithstanding anything to the contrary in this Section 2.1(b), Disc shall be deemed to have Initiated a Phase I Clinical Trial for a Licensed Product in the First Indication in the Licensed Territory if Disc pays Mabwell the Phase I Initiation Payment. (c) By [***] during the Term, Disc will submit a written progress report to Mabwell covering [***], which report in a mutually agreed format shall include information sufficient to enable Mabwell to ascertain progress by Disc or its Sublicensees toward meeting its diligence obligations hereunder (each, a “Progress Report”). Each Progress Report shall describe, where relevant: progress toward Development, obtaining Regulatory Approval for, and Commercialize Commercialization of at least [***] one Licensed Product, including work completed, key scientific discoveries, summary of work-in-progress, current schedule of anticipated events or milestones, estimated total Development time remaining before a Licensed Product will be Commercialized, market plans for introduction of such Licensed Product, and progress of marketing and selling, including the quantities of Licensed Product in inventory and sales information of the Licensed Priority Compounds and at least [***] comprising such Licensed Priority Compound in the United States and EU5 in accordance with the Development plan set forth in Schedule 3.3. Notwithstanding the foregoing or the timeline set forth in Schedule 3.3, during the period commencing on the Effective Date and ending [***] months thereafter, ▇▇▇▇▇▇ shall not be in breach of its obligations under this Section 3.8.1 to the extent Sionna (itself or through its Affiliates or Sublicensees) Develops a Sionna Compound to combine with a Licensed Priority Compound in accordance with the development philosophy set forth in Section (a) of Schedule 3.3. 3.8.2 If at any time AbbVie has a reasonable basis to believe that Sionna is in material breach of its diligence obligations with respect to the Development of any Licensed Compounds or Licensed Products under Section 3.8.1, then AbbVie may so notify ▇▇▇▇▇▇ in writing, specifying the basis for its belief, and, without limitation to any other right or remedy available to AbbVie hereunder, at AbbVie’s request, the Parties shall meet within [***] days after such notice to discuss in good faith AbbVie’s concerns and ▇▇▇▇▇▇’s Development plans with respect to such Licensed Compound or Licensed Product. 3.8.3 If at any time AbbVie has a reasonable basis to believe that Sionna is in material breach of its diligence obligations with respect to Commercialization of any Licensed Compound or Licensed Product under Section 3.8.1, then AbbVie may so notify ▇▇▇▇▇▇ in writing, specifying the basis for its belief, and, without limitation to any other right or remedy available to AbbVie hereunder, at AbbVie’s request, the Parties shall meet within [***] days after such notice to discuss in good faith AbbVie’s concerns and ▇▇▇▇▇▇’s Commercialization plans with respect to such Licensed Compound or Licensed Product.

Diligence Obligations. 3.8.1 Sionna (itself or through 6.1.1. AstraZeneca undertakes to use Commercially Reasonable Efforts at its Affiliates or Sublicensees) shall own cost and expense to develop a Licensed Product and to conduct all development necessary to obtain Health Registration Approvals for a Licensed Product for use in humans in each country listed in the definition of the Major Markets and throughout the Territory. 6.1.2. AstraZeneca undertakes to use Commercially Reasonable Efforts to Developcommercialise a Licensed Product for use in humans in each of the Major Markets and throughout the Territory; provided, however, that such obligations are expressly conditioned upon Palatin and its Affiliates performing their respective obligations hereunder, including the completion of the activities under the Research Collaboration and the information disclosure requirements pursuant to Section 3.4, and such obligations of AstraZeneca shall be delayed or suspended to the extent any such condition causes a delay; and provided further, for the avoidance of doubt, that AstraZeneca shall not be obligated to obtain Regulatory Health Registration Approval for, or commercialise, more than one Licensed Product in any Major Market and Commercialize at least [***] throughout the Territory. In the event that AstraZeneca decides to discontinue the development or commercialisation of the a Licensed Priority Compounds and at least [***] comprising such Product in favour of another Licensed Priority Compound in the United States and EU5 in accordance with the Development plan set forth in Schedule 3.3. Notwithstanding the foregoing or the timeline set forth in Schedule 3.3Product, during the period commencing on the Effective Date and ending [***] months thereafter, ▇▇▇▇▇▇ shall not be in breach of its obligations under this Section 3.8.1 6.1.2. shall cease with respect to such initial Licensed Product in favour of such other Licensed Product. AstraZeneca shall perform its obligation under this Section 6.1.2 in good scientific manner and in compliance in all material respects with all Applicable Law. 6.1.3. Should the extent Sionna (itself use by AstraZeneca of its Commercially Reasonable Efforts have as a consequence that AstraZeneca would be obligated to carry out some or through its Affiliates or Sublicensees) Develops a Sionna Compound to combine with a Licensed Priority Compound in accordance with all of the development philosophy set forth activities provided for in Section (a) of Schedule 3.36.1.1 or 6.1.2 in a country *** then AstraZeneca shall, notwithstanding what is stated in Sections 6.1.1 and 6.1.2 and following consultation with Palatin, be allowed to ***. 3.8.2 If at any time AbbVie has a reasonable basis to believe that Sionna is in material breach 6.1.4. Upon satisfaction of its obligations under Sections 6.1.1 and 6.1.2, AstraZeneca shall be deemed to have satisfied all diligence obligations owed to Palatin hereunder, with respect to the Development Exploitation of any Licensed Compounds or the Agreement Compounds, Licensed Products under Section 3.8.1or Collaboration Results, then AbbVie may so notify ▇▇▇▇▇▇ in writingand shall have no other obligation, specifying express or implied, to Exploit the basis for its beliefAgreement Compounds, and, without limitation to any other right Licensed Products or remedy available to AbbVie hereunder, at AbbVie’s request, the Parties shall meet within [***] days after such notice to discuss in good faith AbbVie’s concerns and ▇▇▇▇▇▇’s Development plans with respect to such Licensed Compound or Licensed ProductCollaboration Results. 3.8.3 If at any time AbbVie has a reasonable basis to believe that Sionna is in material breach of its diligence obligations with respect to Commercialization of any Licensed Compound or Licensed Product under Section 3.8.1, then AbbVie may so notify ▇▇▇▇▇▇ in writing, specifying the basis for its belief, and, without limitation to any other right or remedy available to AbbVie hereunder, at AbbVie’s request, the Parties shall meet within [***] days after such notice to discuss in good faith AbbVie’s concerns and ▇▇▇▇▇▇’s Commercialization plans with respect to such Licensed Compound or Licensed Product.

Diligence Obligations. 3.8.1 Sionna (itself or through its Affiliates or Sublicensees) The parties agree that the following diligence obligations shall use Commercially Reasonable Efforts apply to Develop, obtain Regulatory Approval for, Celldex’s development and Commercialize at least commercialization efforts with regard to a Product incorporating a Licensed Antibody for which it obtains an Exclusive Commercial License: 8.3.1 If upon the [*****] anniversary of the Licensed Priority Compounds and at least date that Celldex obtains an Exclusive Commercial License with respect to a Product, Celldex has not filed an IND for such Product in any country, Celldex shall pay Medarex a nonrefundable, noncreditable fee of [*****] comprising per year to maintain such Licensed Priority Compound Exclusive Commercial License with respect to such Product until the earlier of (i) the date that Celldex files an IND for such Product in any country, (ii) the United States and EU5 in accordance date Celldex terminates the Exclusive Commercial License with respect to such Product pursuant to Section 4.3.3, or (iii) the Development plan set forth in Schedule 3.3. Notwithstanding the foregoing or the timeline set forth in Schedule 3.3, during the period commencing on the Effective Date and ending [*****] months thereafter, ▇▇▇▇▇▇ shall not be in breach anniversary of its obligations under this Section 3.8.1 the date that Celldex obtains an Exclusive Commercial License with respect to the extent Sionna (itself or through its Affiliates or Sublicensees) Develops a Sionna Compound to combine with a Licensed Priority Compound in accordance with the development philosophy set forth in Section (a) of Schedule 3.3such Product. 3.8.2 8.3.2 If at upon the [*****] anniversary of the date that Celldex obtains an Exclusive Commercial License with respect to a Product, Celldex has not filed an IND for such Product in any time AbbVie has a reasonable basis country, all rights granted to believe that Sionna is in material breach Celldex hereunder with respect to such Product (and corresponding Antibodies) shall revert to Medarex and the terms of its diligence obligations Section 4.3.3 shall apply with respect to the Development of any Licensed Compounds or Licensed Products under Section 3.8.1, then AbbVie may so notify ▇▇▇▇▇▇ in writing, specifying the basis for its belief, and, without limitation to any other right or remedy available to AbbVie hereunder, at AbbVie’s request, the Parties shall meet within applicable Exclusive Commercial License. [*****] days after REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. 8.3.3 If upon the [*****] anniversary of the date that Celldex files an IND, if any, for such notice Product in any country, Celldex has not initiated a Phase II Clinical Trial with regard to discuss in good faith AbbVie’s concerns and ▇▇▇▇▇▇’s Development plans such Product, Celldex shall pay a nonrefundable, noncreditable fee equal to [*****] with regard to such Product each year until such time as Celldex initiates a Phase II Clinical Trial with regard to such Product, unless Celldex terminates the Exclusive Commercial License with respect to such Licensed Compound or Licensed ProductProduct pursuant to Section 4.3.3. 3.8.3 8.3.4 If at any time AbbVie has a reasonable basis to believe that Sionna is in material breach of its diligence obligations with respect to Commercialization of any Licensed Compound or Licensed Product under Section 3.8.1, then AbbVie may so notify ▇▇▇▇▇▇ in writing, specifying upon the basis for its belief, and, without limitation to any other right or remedy available to AbbVie hereunder, at AbbVie’s request, the Parties shall meet within [*****] days after anniversary of the date that Celldex initiates Phase II Clinical Trials for such notice Product, Celldex has not initiated a Phase III Clinical Trial with regard to discuss in good faith AbbVie’s concerns and ▇▇▇▇▇▇’s Commercialization plans such Product, Celldex shall pay a nonrefundable, noncreditable fee equal to [*****] with regard to such Product each year until such time as Celldex initiates Phase III Clinical Trials with regard to such Product, unless Celldex terminates the Exclusive Commercial License with respect to such Licensed Compound or Licensed ProductProduct pursuant to Section 4.3.3.