Diligence. AVROBIO will use Commercially Reasonable Efforts to Develop and Commercialize one or more Licensed Products in the United States and in the Major European Countries. In addition, and without limiting the generality of the foregoing, AVROBIO shall initiate an IND-enabling pharmacology/toxicology study of a Licensed Product within [***] of the Effective Date. In the event that BioMarin believes AVROBIO is in material breach of its obligation to use Commercially Reasonable Efforts under this Section 3.3, 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 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. AVROBIO will use Commercially Reasonable (a) Fibrocell shall use, and shall require its sublicensees to use, Diligent Efforts to Develop develop and Commercialize one or more Licensed Fibrocell Products in and Improved Products. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the United States Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and in the Major European Countries. In addition, and without Exchange Commission.
(b) Without limiting the generality of the foregoing, AVROBIO Intrexon may, from time to time, notify Fibrocell that it believes it has identified a Superior Therapy, and in such case Intrexon shall initiate an INDprovide to Fibrocell its then-enabling pharmacology/toxicology study available information about such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy. Fibrocell shall have the following obligations with respect to such proposed Superior Therapy: (i) within sixty (60) days after such notification, Fibrocell shall prepare and deliver to the JSC for review and approval a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise the development plan as directed by the JSC; and (iii) following approval of the development plan by the JSC, Fibrocell shall use Diligent Efforts to pursue the development of the Superior Therapy under the Fibroblast Program in accordance with such development plan. If Fibrocell fails to comply with the foregoing obligations, or if Fibrocell unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a Licensed Product within [***] of the Effective Date. In the event that BioMarin believes AVROBIO is in material breach of its obligation to use Commercially Reasonable Efforts under this Section 3.3, then BioMarin may so notify AVROBIO in writing, which notice shall provide available details regarding the basis development plan for its belief and specifying that a Superior Therapy; (y) delay such notice approval more than sixty (a “Diligence Breach Notice”60) 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 [***] days after delivery of such the development plan to the JSC; or (z) approve a written report from AVROBIO development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth in Section 10.2(c) (subject to discuss in good faith the concerns raised by BioMarin and shall conduct such additional meetings as are reasonably necessary to reach agreement limitation set forth therein). For clarity, any dispute arising under this 4.5, including any dispute as to whether or not AVROBIO is in material breach of its obligations a proposed project constitutes a Superior Therapy (as with any other dispute 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 Agreement) shall be referred subject to the dispute resolution procedure outlined under Section 11.3, which procedure in accordance with Article 11.
(c) The activities of Fibrocell’s Affiliates and any permitted sublicensees shall be required to: (a) determine whether there was, in fact, a material breach by AVROBIO attributed to Fibrocell for the purposes 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 breach evaluating Fibrocell’s fulfillment of the diligence obligation hereunder, and AVROBIO does not commence or complete the cure efforts specified by the arbitration result (obligations set forth 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 3.34.5.
Appears in 3 contracts
Samples: Exclusive Channel Collaboration Agreement (Castle Creek Biosciences, Inc.), Exclusive Channel Collaboration Agreement (Castle Creek Biosciences, Inc.), Exclusive Channel Collaboration Agreement (Fibrocell Science, Inc.)
Diligence. AVROBIO will use Commercially Reasonable Efforts to Develop and Commercialize one or more Licensed Products in the United States and in the Major European Countries. In addition, and without limiting the generality of the foregoing, AVROBIO shall initiate an IND-enabling pharmacology/toxicology study of a Licensed Product within [***] of the Effective Date. In the event that BioMarin believes AVROBIO is in material breach of its obligation to use Commercially Reasonable Efforts under this Section 3.3, 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”a) 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 [***] As soon as practicable after receipt of Government Approval to market any Product in any country in the Territory, Purchaser shall thereafter use its Best Efforts to market, promote and commercialize such notice, provide a written report to BioMarin to justify why AVROBIO believes it is not Product in such material breach country during the term 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 Agreement.
(b) if it is determined Purchaser agrees to use its Best Efforts to obtain in writing any waivers that there was may be necessary under any Applicable Laws in the Territory (or outside the Territory to the extent informed thereof by Manufacturer).
(c) Purchaser shall promptly notify Manufacturer of any inquiry (other than an uncured material breachorder or potential order from a customer within the Territory) from any Governmental Authority (including the Commission, specify what additional efforts AVROBIO must undertake a Competent Authority, a Notified Body or the FDA) concerning the Products or Manufacturer.
(d) Purchaser shall notify Manufacturer promptly upon Purchaser's receipt of any actual notice that a Notified Body, a Competent Authority or the FDA intends to cure such breach, and visit or inspect Purchaser's facilities in 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 Territory for a material breach purpose relevant to the development or marketing of the diligence obligation hereunder, Products and AVROBIO does not commence provide Manufacturer with copies of all correspondence relating thereto and an opportunity to participate in any inspection or complete the cure efforts specified regulatory comments or correspondence prepared by the arbitration result (Purchaser in response to such comments.
(e) Purchaser and Manufacturer shall promptly notify each other of any and all Adverse Device Events, or any events that could reasonably be expected to become an Adverse Device Event, of which it becomes aware and will forward promptly to the clause (b) requirement above) by the required relevant datesother all written reports relating to such actual or potential Adverse Device Event. Purchaser shall also forward to Manufacturer any explanted Products, then BioMarin may terminate the Agreement pursuant if available. Subject to Section 8.29.2, Purchaser shall be responsible for, and bear the cost of, any correspondence with Governmental Authorities in the Territory related to any such Adverse Device Event to the extent related to any Government Approval in the Territory for which Purchaser is responsible hereunder. All efforts Subject to Section 9.2, Manufacturer shall be responsible, and bear the cost of, all other requirements, regulatory filings or measures resulting from such Adverse Device Event.
(f) Purchaser shall not knowingly sell, lease, give or otherwise dispose of AVROBIO’s Affiliatesany Product to any person or entity other than a duly qualified medical practitioner or hospital and not knowingly sell, Third Party contractors lease, give or otherwise dispose of any Product for any use or application other than one particularly authorized by Manufacturer in writing or in literature and sublicensees will be considered efforts of AVROBIO labeling accompanying the Product.
(g) Purchaser shall provide customer support services in the Territory at levels consistent with Purchaser's Best Efforts obligation to develop the market for the purpose Products within the Territory, subject to industry standards for customary levels of determining AVROBIO’s compliance with its obligations under this Section 3.3support services for similar products.
Appears in 2 contracts
Samples: Manufacturing Agreement (Angeion Corp/Mn), Manufacturing Agreement (Angeion Corp/Mn)
Diligence. AVROBIO (a) After the JSC's selection of the Lead Product, MedCo will use Commercially Reasonable Efforts to (i) Develop and Commercialize at least one or more Licensed Products in the United States and in the Major European Countries. In addition, and without limiting the generality of the foregoing, AVROBIO shall initiate an IND-enabling pharmacology/toxicology study of a Licensed Product within [***] and obtain Regulatory Approval of at least one Licensed Product in each Major Market Country and (ii) subject to Section 2.3.2, perform the Effective Date. In Development activities under the event that BioMarin believes AVROBIO is in material breach of its obligation to MedCo Development Plan.
(b) Alnylam will use Commercially Reasonable Efforts to perform the Development activities under the Initial Development Plan and, subject to Section 2.3.2, those activities under the MedCo Development Plan which Alnylam has agreed in writing to undertake; provided, however, that except as expressly provided in this Section 3.3Agreement or otherwise agreed to in writing by Alnylam, then BioMarin may so notify AVROBIO in writingno event will Alnylam be required to perform any activities under the Initial Development Plan or the MedCo Development Plan with respect to Licensed Products that would require Alnylam to incur Costs in excess of the then-applicable Development Costs Cap, which notice shall provide available details regarding unless paid or payable by MedCo as Extra Early Development Costs. Alnylam will be excused from its obligation to perform its affected Development and Manufacturing obligations with respect to Licensed Products under 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 Transaction Agreements during any period of [***] after receipt time with respect to which Alnylam cannot perform such obligations to the extent that, (i) Alnylam becomes aware that the performance of such noticeobligations would infringe Patent Rights that MedCo Controls and are reasonably necessary for such performance by Alnylam, provide a written report to BioMarin to justify why AVROBIO believes it and (ii) Alnylam is not in protected by any safe harbor provisions with respect to claims that it would infringe such material breach of such diligence obligationPatent Rights. If no such report is provided by AVROBIO by the end of such time period, BioMarin shall be permitted The Parties agree 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 promptly discuss in good faith the concerns raised by BioMarin and shall conduct a mutually agreed resolution to 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 meetinga situation. If after such [***] period following the initial meeting, the Parties cannot reach agreement thenagree in writing that MedCo will grant Alnylam a license or sublicense under such Patent Rights, 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 breach of the diligence obligation hereunder, and AVROBIO does not commence or complete the cure efforts specified then unless otherwise agreed by the arbitration result (Parties in response to the clause (b) requirement above) by the required relevant dateswriting, then BioMarin may terminate the Agreement pursuant to Section 8.2. All efforts of AVROBIO’s Affiliates, Third Party contractors and sublicensees such Patent Rights will be considered efforts of AVROBIO for MedCo Patent Rights, and if such Patent Rights are licensed to MedCo or its Affiliate by a Third Party, such sublicense shall be subject to the purpose of determining AVROBIO’s compliance with relevant license agreement to MedCo or its obligations under this Section 3.3Affiliate from such Third Party and such agreement shall be designated a MedCo In-License.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Medicines Co /De), License and Collaboration Agreement (Medicines Co /De)
Diligence. AVROBIO will 3.2.1 EPIZYME shall use Commercially Reasonable Efforts (itself or through an Affiliate or Sublicensee) to Develop Develop, obtain Regulatory Approval for and Commercialize one or more Licensed Products at least [**] in each of the United States and in the Major European EU Countries. In additionFor clarity, and without limiting the generality of the foregoing, AVROBIO EPIZYME shall initiate an IND-enabling pharmacology/toxicology study of a Licensed Product within [***] of the Effective Date. In the event that BioMarin believes AVROBIO is in material breach of its not have any obligation to use Commercially Reasonable Efforts under this Section 3.3to Develop, then BioMarin may so notify AVROBIO in writing, which notice shall provide available details regarding the basis obtain Regulatory Approval 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 or Commercialize more than [***] after receipt of such noticein any country outside the United States and the Major EU Countries.
3.2.2 EISAI shall use Commercially Reasonable Efforts (itself or through an Affiliate or Sublicensee) to conduct Japan-Specific Development Activities for, 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 obtain Regulatory Approval for and Commercialize at least [**] in Japan; provided that, if EPIZYME does not conduct such global Development activities (excluding Japan-Specific Development Activities) as are necessary to submit an application for Regulatory Approval for at least [**] after delivery in Japan or if EPIZYME does not comply with its obligations under Section 3.3 and the supply agreement(s) contemplated thereby, then EISAI shall, for the duration of such a written report EPIZYME’s noncompliance, be excused 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 3.2.2 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 extent the conduct of such global Development activities or such compliance by AVROBIO of its diligence obligation, and (b) if it EPIZYME is determined that there was an uncured material breach, specify what additional efforts AVROBIO must undertake reasonably necessary for EISAI 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 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 satisfy its obligations under this Section 3.33.2.2. For clarity, EISAI shall not have any obligation to use Commercially Reasonable Efforts to conduct Japan-Specific Development Activities for, obtain Regulatory Approval for or Commercialize, more than [**] in Japan.
3.2.3 Subject to the foregoing obligations to use Commercially Reasonable Efforts, neither Party provides any representation, warranty or guarantee that the Collaboration will be successful or that any particular results will be achieved with respect to the Collaboration, EZH2, or any Compound, Licensed Compound or Licensed Product hereunder.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Epizyme, Inc.), Collaboration and License Agreement
Diligence. AVROBIO will AbbVie shall use Commercially Reasonable Efforts to Develop and Commercialize one or more Licensed Products in the United States and in the Major European Countries. In addition, and without limiting the generality of the foregoing, AVROBIO shall initiate an IND-enabling pharmacology/toxicology study of a Licensed Product within [***] ]; provided that (a) such obligation is expressly conditioned upon Licensor’s and 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 addition to the foregoing, (a) the Commercialization of Licensed Product may be delayed, suspended or otherwise modified by AbbVie in response to circumstances outside the Effective Datereasonable 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 (c) nothing in this Section 4.3 is intended, or shall be construed, to require AbbVie to Develop or Commercialize a specific Licensed Antibody or Licensed Product. In If AbbVie decides to discontinue the event 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 time Licensor has a reasonable basis to believe that BioMarin believes AVROBIO AbbVie is in material breach of its obligation to use Commercially Reasonable Efforts material obligations under this Section 3.34.3, then BioMarin Licensor may so notify AVROBIO in writingAbbVie, which notice shall provide available details regarding specifying the basis for its belief 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 meet within [***] after delivery of such a written report from AVROBIO notice to discuss in good faith Licensor’s concerns and AbbVie’s Commercialization plans with respect to Licensed Product. *** Certain information in this agreement has been omitted and filed separately with the concerns raised by BioMarin Securities 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 Exchange Commission. [***] after such initial meeting. If after such [***] period following indicates that text has been omitted and is the initial meeting, the Parties cannot reach agreement then, upon request subject 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 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 3.3confidential treatment request.
Appears in 2 contracts
Samples: Co Development and Option Agreement (Alector, Inc.), Co Development and Option Agreement (Alector, Inc.)
Diligence. AVROBIO will (a) During the Research Term, Aventis shall use Commercially Reasonable Efforts * to perform its Research obligations in accordance with the Research Plan. During the Term, Aventis agrees to use * to Develop and Commercialize Collaboration Products.
(b) The Parties agree that any Target presented by Avalon to the Research Committee in accordance with Section 3.4 which is not accepted by the Research Committee as a DRG within * shall not become a DRG or be included in the Research Program, and all rights to such Target shall remain with Avalon.
(c) The Parties agree that a DRG shall become a Reversion Target in the event of one or more Licensed Products of the following:
(i) if within * after a Target that is identified by Avalon during the Research Term is accepted by the Research Committee for inclusion in the United States Research Program as a DRG, such DRG is not selected as a SQT; or
(ii) if within * after a Target is selected as a DRG, (and assuming that Aventis subsequently selects it as an SQT), such DRG is not selected as an Advanced SQT; or
(iii) if Aventis determines not to Develop or to continue to Develop a Collaboration Product for an Advanced SQT; or * The asterisk denotes the confidential portions of this exhibit have been omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential portions have been submitted separately to the Securities Exchange Commission.
(iv) if Aventis does not use * to Develop and Commercialize Collaboration Products with respect to a selected Advanced SQT; or
(v) if, for any reason, Aventis determines not to Develop or to discontinue Development of a DRG.
(d) All rights to Reversion Targets shall revert to Avalon and Avalon may use any such Reversion Targets for any purpose, and may license Reversion Targets to Third Parties or collaborate with Third Parties with respect to Reversion Targets.
(e) With respect to each SQT and each Advanced SQT that becomes a Reversion Target, Aventis shall provide Avalon with the pre-clinical information and data (“Aventis Target Technology”) in the Major European Countries. In addition, Control of Aventis at the time such Target becomes a Reversion Target with respect to such Reversion Target that is useful for identifying Reversion Products by use of such Reversion Targets and without limiting the generality of the foregoing, AVROBIO shall initiate an INDnon-enabling pharmacology/toxicology study of a Licensed Product within [***] of the Effective Date. In the event that BioMarin believes AVROBIO is in material breach of its obligation exclusive right and license to use Commercially Reasonable Efforts under this Section 3.3and to sublicense such Aventis Target Technology with respect to Reversion Targets, then BioMarin may so notify AVROBIO provided that in writingno event shall Aventis Target Technology include any information or data relating to compounds, 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 molecules 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 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 3.3antibodies.
Appears in 1 contract
Samples: Collaboration and License Agreement (Avalon Pharmaceuticals Inc)
Diligence. AVROBIO will 3.1 Licensee shall use Commercially Reasonable Efforts its commercially reasonable efforts consistent with other opportunities of similar scope to Develop establish the commercial feasibility of bringing Pyridorin Products and Commercialize one or more Licensed AGE-Inhibitor Products in (to the United States extent Licensee receives rights under the AGE-Inhibitor Patent Rights hereunder) into commercial sale and in the Major European Countries. In additionuse, and without limiting upon establishing such feasibility, to bring such products into commercial sale and use as quickly as is reasonably possible. This Agreement and the generality licenses granted herein shall be subject to, and Licensee shall comply with, all applicable terms, requirements, and obligations of the KUMCRI Agreement and USC Agreement, including but not limited to the diligence requirements included therein.
3.2 As evidence of its reasonable efforts to effect the introduction of Pyridorin Products and AGE-Inhibitor Products, Licensee agrees to maintain an active commercialization effort defined as meeting any one of the following criteria:
(1) Funding research or product development programs that directly contribute to the commercialization of the Pyridorin Products and AGE-Inhibitor Products at the Licensee or through sponsored research/development agreements with research institutions or contract research organizations directed to the development and commercialization of a product that incorporates Pyridorin or an AGE-Inhibitor;
(2) Assigning or sublicensing (each in accordance with the terms of this Agreement) the product rights licensed or assigned hereunder to another company directed to the development and commercialization of a product that incorporates Pyridorin or an AGE- Inhibitor.
3.3 Subject to the cure period discussed below, BioStratum shall have the right to terminate this Agreement effective upon written notice if Licensee does not close a Qualified Series A Financing on or before June 30, 2006. Notwithstanding the foregoing, AVROBIO if BioStratum enters into a strategic partnership pursuant to which BioStratum receives nonrefundable proceeds of at least $2,000,000 by June 30, 2006, then the period of time for Licensee to close a Qualified Series A Financing shall initiate an IND-enabling pharmacology/toxicology study of a Licensed Product within [***] of the Effective Datebe extended to December 31, 2006. In the event that BioMarin believes AVROBIO is Licensee has not closed a Qualified Series A Financing nor entered into a strategic partnership (as described in material breach the preceding sentence) by June 30, 2006, the receipt of its obligation to use Commercially Reasonable Efforts under the written termination notice described in the first sentence of this Section 3.33.3 shall trigger a forty-five (45) day cure period (the “Cure Period”), during which time (i) Licensee may continue to work towards either closing a Qualified Series A Financing or entering into such a strategic partnership and (ii) BioStratum shall be free to enter into discussions regarding a transaction or transactions involving AGE-Inhibitors, AGE-Inhibitor Know- How, AGE-Inhibitor Patent Rights, AGE-Inhibitor Products, Pyridorin, Pyridorin Know-How, Pyridorin Patent Rights and/or Pyridorin Products, including but not limited to a sale, license or strategic partnership, provided, however, that in no event shall BioStratum enter into such discussions during such cure period with a venture capital investment fund. If Licensee closes a Qualified Series A Financing during such Cure Period, BioStratum shall withdraw its written termination notice and this Agreement shall continue in full force and effect. If Licensee does not close a Qualified Series A Financing during such Cure Period, then BioMarin may so notify AVROBIO in writingthis Agreement shall terminate upon the expiration of the Cure Period. For purposes of clarification, which notice Licensee 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 only be permitted to take advantage of one Cure Period, unless otherwise consented by BioStratum.
3.4 BioStratum shall have the right to terminate this Agreement pursuant effective upon written notice if Licensee does not, within 18 months of the closing of the Qualified Series A Financing, accomplish at least one of the following: (i) initiate a new Phase II clinical trial of Pyridorin Product as a treatment for diabetic nephropathy, (ii) enter into a contract with a strategic partner for which provides funding reasonably sufficient to Section 8.2support the development of a Pyridorin Product as a treatment for diabetic nephropathy, or (iii) close a Qualified Series B Financing. If AVROBIO provides a responseUpon Licensee's request, BioStratum may provide Licensee with an additional 90 day period to meet the Parties shall then conduct an initial meeting within [***] after delivery foregoing requirement. Approval of such a written report from AVROBIO to discuss in good faith the concerns raised by BioMarin and request shall conduct such additional meetings as are reasonably necessary to reach agreement as to whether not be unreasonably withheld, conditioned 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 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 3.3delayed.
Appears in 1 contract
Diligence. AVROBIO will use Commercially Reasonable Efforts to Develop and Commercialize one or more Licensed Products in the United States and in the Major European Countries. In addition, and without limiting the generality of the foregoing, AVROBIO shall initiate an IND-enabling pharmacology/toxicology study of a Licensed Product within [***] of the Effective Date. In the event that BioMarin believes AVROBIO is in material breach of its obligation to use Commercially Reasonable Efforts under this Section 3.3, 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 1 contract
Samples: License Agreement
Diligence. AVROBIO will (a) ZENYAKU shall use Commercially Reasonable Efforts to Develop develop, seek Regulatory Approval for and Commercialize one or more Licensed Products commercialize the Product for the Initial Indication and for SLE in the United States ZENYAKU Territory; provided that ANTHERA shall be responsible for activities within the Joint Development Plan with respect to clinical trials for the Initial Indication and CHABLIS-SC2 Study contained therein, as well as to conduct the CHABLIS-SC1 Study. It is understood and agreed that ZENYAKU’s regulatory package to seek approval for the Initial Indication and SLE will include, and approval in the Major European Countries. In additionZENYAKU Territory for the Initial Indication and SLE will depend upon, respectively (x) the data for the Initial Indication that will be generated by ANTHERA for this indication under the Joint Development Plan, and without limiting (y) the generality data for SLE that will be generated by ANTHERA in conducting the CHABLIS-SC1 Study and the CHABLIS-SC2 Study in the Joint Development Plan. Accordingly, if ANTHERA fails to conduct the activities within the Joint Development Plan necessary to generate the data for the Initial Indication, or fails to conduct the CHABLIS-SC1 Study or the activities within the Joint Development Plan necessary to generate the data for SLE, then ZENYAKU’s ability to develop and seek Regulatory Approval in the ZENYAKU Territory may be harmed and ZENYAKU shall not to be deemed in breach of its diligence obligation set forth in the foregoingfirst sentence of this Section. *** Confidential Information, AVROBIO shall initiate an IND-enabling pharmacology/toxicology study of a Licensed Product within indicated by [***] ], has been omitted from this filing and filed separately with the Securities and Exchange Commission.
(b) Should ZENYAKU choose to develop the Product for any other Indication, it must so notify ANTHERA in writing (e.g., through the process described above for updating the ZENYAKU Development Plan). If ANTHERA has any concerns, the parties shall convene a meeting of the Effective DateJDC to discuss the matter, and ZENYAKU shall reasonably consider ANTHERA’s concerns. In the event that BioMarin believes AVROBIO is in material breach of its ZENYAKU shall not have any obligation to use devote Commercially Reasonable Efforts under this Section 3.3for any Indication other than the Initial Indication (express or implied, then BioMarin may so notify AVROBIO at law or in writingequity), which notice shall provide available details regarding and its Commercially Reasonable Efforts obligations for 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 Initial Indication 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 subject to the dispute resolution procedure outlined under limitations and conditions above in 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 reasonable4.5(a). If such procedure determines that there was a material 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 1 contract
Samples: Collaboration and License Agreement (Anthera Pharmaceuticals Inc)
Diligence. AVROBIO will use Commercially Reasonable Efforts AlgoRx shall exercise commercially reasonable efforts to Develop and Commercialize one develop, or more Licensed to license to a Third Party to develop, each of the AlgoRx Named Products in the United States and in the Major European Countries. In additionorder to retain such product as an AlgoRx Named Product, and without limiting the generality of the foregoing, AVROBIO shall initiate an IND-enabling pharmacology/toxicology study of a Licensed Product within [expend (or its licensee shall expend) at least ***] of the Effective Date. In the event that BioMarin believes AVROBIO is in material breach of its obligation to use Commercially Reasonable Efforts under this Section 3.3, 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 * per **** in research and development to support such efforts per AlgoRx Named Product until Regulatory Approval is achieved; provided that the foregoing shall apply to only one AlgoRx Named Product in a closely-related class of such notice, provide a written report to BioMarin to justify why AVROBIO believes it is not in such material breach AlgoRx Named Products that are established by agreement of such diligence obligation. If no such report is the Parties as provided by AVROBIO by at the end of Section 2.3(a). PRL shall exercise commercially reasonable efforts to develop, or to license to a Third Party to develop, each of the PowderJect Named Products in order to retain such time periodproduct as an PowderJect Named Product, BioMarin and shall be permitted to terminate this Agreement pursuant to Section 8.2. If AVROBIO provides a response, the Parties expend (or its licensee shall then conduct an initial meeting within [expend) at least ***] **** per **** in research and development to support such efforts per PowderJect Named Product until Regulatory Approval is achieved; provided that the foregoing shall apply to only one PowderJect Named Product in a closely-related class of PowderJect Named Products that are established by agreement of the Parties as provided at the end of Section 2.3(b). Twelve (12) months after delivery designation of such an Selectable Product as either an AlgoRx Named Product or a written report from AVROBIO PowderJect Named Product (and once every subsequent twelve-month period), the designating Party shall provide 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 other Party an annual summary of its diligence with respect to such product. If, with respect to a particular Named Product, the designating Party (or its Affiliate or sublicensee) has, during the applicable twelve-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 3.3 for an additional [***] after 2.4(c) with respect to such initial meetingNamed Product. If after such [***] period following the initial meetingdesignating Party (or its Affiliate or sublicensee) has not expended the required amount of development funding on, the Parties canor is not reach agreement then, upon request of either Party, the matter shall be referred otherwise continuing to the dispute resolution procedure outlined under Section 11.3, which procedure shall be required to: (a) determine whether there was, in factuse commercially reasonable efforts to develop, a material breach by AVROBIO of its diligence obligationparticular Named Product, and (b) if it is determined that there was an uncured material breach, specify what additional efforts AVROBIO must undertake then such Named Product shall cease to cure such breachbe the designating Party's Named Product, and the time period during which non-designating Party shall have the co-exclusive rights to pursue such efforts must product and shall also be commenced and completed (which time period shall be commercially reasonable). If free to designate such procedure determines that there was a material breach product as its own Named Product under the above terms 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 3.32.3.
Appears in 1 contract
Diligence. AVROBIO Calithera will use Commercially Reasonable Efforts to Develop and Commercialize to obtain Marketing Approvals for at least one or more Licensed Products Product in the United States Field [*], as soon as reasonably practicable. Calithera shall provide notice to Symbioscience if at any time during the Term it decides to abandon the further Development and in the Major European CountriesCommercialization of all Licensed Compounds and Licensed Products. In additionAny such notice shall constitute notice by Calithera to terminate, and without limiting will result in termination of, the generality of the foregoing, AVROBIO shall initiate an IND-enabling pharmacology/toxicology study of a Licensed Product within [***] of the Effective DateAgreement pursuant to Section 10.3. In the event that BioMarin Symbioscience believes AVROBIO Calithera is in material breach of its obligation to use Commercially Reasonable Efforts under this Section 3.33.4, then BioMarin Symbioscience may so notify AVROBIO Calithera 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 Symbioscience pursuant to this Section 3.33.4. If a Diligence Breach Notice is provided to AVROBIOCalithera, AVROBIO Calithera may, within a further period of [***] days after its receipt of such notice, provide a written report to BioMarin Symbioscience to justify why AVROBIO Calithera believes it is not in such material breach of such diligence obligation. If no such report is provided by AVROBIO Calithera by the end of such time period, BioMarin Symbioscience shall be permitted to terminate this Agreement pursuant to Section 8.29.3. If AVROBIO Calithera provides a response, the Parties shall then conduct an initial meeting within [***] days after delivery of such a written report from AVROBIO Calithera to discuss in good faith the concerns raised by BioMarin Symbioscience and shall conduct such additional meetings as are reasonably necessary to reach agreement as to whether or not AVROBIO Calithera is in material breach of its obligations under this Section 3.3 3.4 for an additional [***] days after such initial meeting. If after such [***] day 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 11.313.3, which procedure shall be required to: (a) determine whether there was, in fact, a material breach by AVROBIO Calithera of its diligence obligation, and (b) if it is determined that there was an uncured material breach, specify what additional efforts AVROBIO Calithera 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 breach of the diligence obligation hereunder, and AVROBIO Calithera 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 Symbioscience may terminate the Agreement pursuant to Section 8.29.3. All efforts of AVROBIOCalithera’s Affiliates, Third Party contractors and sublicensees Sublicensees will be considered efforts of AVROBIO Calithera for the purpose of determining AVROBIOCalithera’s compliance with its obligations under this Section 3.33.4.
Appears in 1 contract
Samples: Collaboration and License Agreement (Calithera Biosciences, Inc.)
Diligence. AVROBIO will From the Closing Date and until the later of (x) the payment of all Contingent Payments due hereunder and (y) the expiration of the Royalty Term, the Purchaser shall (A) operate the Business in the ordinary course of business consistent with its conduct of its business prior to the Closing Date and the Purchaser shall take all actions reasonably necessary or advisable to maximize the Contingent Payments, (B) use Commercially Reasonable Efforts to Develop maximize the Contingent Payments hereunder, (C) refrain from intentionally or knowingly taking any action that would reasonably be expected to impair or prevent the Purchaser in any material respect from achieving Milestone Events and Commercialize one or more Licensed Products taking Commercially Reasonable Efforts to maximize Contingent Payments, and (D) use reasonable efforts in collecting the Receivables during the Royalty Term taking into account the issues attendant to collecting receivables owed to the estate of a chapter 11 debtor; provided, however, that the Purchaser shall not be required in connection with such efforts to pursue legal remedies in respect of any Receivable. If the Purchaser determines not to pursue further collection efforts with respect to a Receivable, it shall include in the United States next Quarterly Report the identity and in amount of such Receivable and, upon the Major European Countrieswritten request from Sellers, shall transfer ownership of such receivable to the Indenture Trustee. In addition, and without limiting the generality of Notwithstanding the foregoing, AVROBIO shall initiate an INDSellers acknowledge and agree that (1) continued development, Commercialization and Exploitation of Purchaser’s long-enabling pharmacology/toxicology study acting injectable testosterone product by or on behalf of Purchaser or any of its Affiliates, and (2) the acquisition, in-licensing, development, Commercialization or Exploitation by or on behalf of Purchaser or any of its Affiliates of any other non-oral testosterone product, in each case, will not constitute a Licensed Product within [***] of the Effective Date. In the event that BioMarin believes AVROBIO is in material breach of its obligation subsection (C) of this Section 2.5(c)(viii). Notwithstanding anything to the contrary in this Section 2.5(c)(viii), the Purchaser hereby agrees and covenants that it shall use Commercially Reasonable Efforts under this Section 3.3, then BioMarin may so notify AVROBIO in writing, which notice shall provide available details regarding to initiate Commercialization of the basis for its belief and specifying that such notice Products within thirty (a “Diligence Breach Notice”30) 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 days following the initial meetingClosing Date, including dedicating, committing, or assigning no less than seventy-five (75) individual field employees for the Parties cannot reach agreement thenCommercialization, 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, marketing 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 breach sales 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 3.3Product.
Appears in 1 contract
Samples: Asset Purchase Agreement (Clarus Therapeutics Holdings, Inc.)
Diligence. AVROBIO After the Closing Date, InterMune has sole responsibility for all aspects of developing, obtaining Regulatory Approval for, manufacturing and commercializing the Initial Product throughout the Territory. InterMune will use devote Commercially Reasonable Efforts to Develop and Commercialize one or more Licensed Products (as defined in the United States following sentence) to obtain and maintain Regulatory Approval for the Initial Product in a specific country consistent with the Major European CountriesDevelopment Plan or to commercialize Initial Product in a specific country consistent with the Commercialization Plan. In additionFor purposes of this section only, "Commercially Reasonable Efforts" means the level of effort, expertise and resources required to commercialize Product that a similarly situated biopharmaceutical company would typically devote to a product of similar marketing potential, profit potential or strategic value, based on conditions then prevailing. If Lilly believes that InterMune is not devoting Commercially Reasonable Efforts for the Initial Product in any country, Lilly will notify InterMune in writing detailing its specific concerns and recommendations, and without limiting the generality of the foregoing, AVROBIO shall initiate an IND-enabling pharmacology/toxicology study of a Licensed Product Parties will meet within [**] of such written notice to discuss such concerns and recommendations. After the last of such meeting(s), InterMune will have [*] of the Effective Date. In the event that BioMarin believes AVROBIO is in material breach of to devote its obligation to use Commercially Reasonable Efforts under this Section 3.3, 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 3.3as set forth above. If a Diligence Breach Notice is provided to AVROBIOInterMune subsequently defaults and does not devote Commercially Reasonable Efforts for the Initial Product in any country, 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 Lilly will have the end of such time period, BioMarin shall be permitted right to terminate the licenses granted in this Agreement to InterMune for such specific country pursuant to Section 8.2. If AVROBIO provides a response9.1(c), the Parties shall then conduct an initial meeting within below, [**] and InterMune will grant to Lilly an exclusive license to all rights, InterMune Technology and data that are useful and necessary for Lilly to obtain (or maintain) Regulatory Approval to commercialize the Initial Product in such country. [*] 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 meetingCERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. 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 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 3.3CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Appears in 1 contract
Samples: Asset Purchase and License Agreement (Intermune Inc)
Diligence. AVROBIO will (a) ArQule shall use Commercially Reasonable Efforts to Develop Diligence in proceeding with the development of the Optioned Compounds in the Field, except that ArQule's obligation hereunder shall expire upon the earlier of the Option Exercise, if any, and Commercialize the expiration of the Option Term. From and after the Option Exercise, Roche shall use Reasonable Diligence in proceeding with the development of at least one Product, including obtaining required Regulatory Approvals, and manufacturing, marketing and selling such Product or more Licensed Products in the United States Major Market Countries.
(b) If either Party believes in good faith that the other Party has failed to utilize Reasonable Diligence as required by this Section 3.1, then such Party may give the other Party written notice of such alleged failure, identifying the Optioned Compounds or Product (if known) and giving specific detailed reasons supporting such allegation. Within * following the other Party's receipt of any such notice ("Response Period"), the other Party shall have the right to provide such Party with a written response specifying, in reasonable detail, how it has used Reasonable Diligence as required hereby.
(c) If the Major European Countries. In additionother Party has failed to provide within the Response Period a written response, and without limiting in reasonable detail, indicating the generality of the foregoing, AVROBIO shall initiate an IND-enabling pharmacology/toxicology study of a Licensed Product within [***] of the Effective Date. In the event that BioMarin believes AVROBIO manner in which it is in material breach of compliance with its obligation to use Commercially Reasonable Efforts obligations under this Section 3.33.1 or in which it has remedied any breach thereof, then BioMarin may so notify AVROBIO in writing, which notice shall provide available details regarding or the basis for its belief and specifying that such notice (a “Diligence Breach Notice”) is being provided by BioMarin pursuant other Party has failed within the Response Period 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 remedy any breach of its obligations under this Section 3.3 for an additional [***] after 3.1, then the Party alleging failure of Reasonable Diligence shall have the right to terminate this Agreement upon written notice to such initial meeting. If after Party effective as of the end of the Response Period, in addition to any other rights it may have under this Agreement as a result of such [***] period following breach.
(d) In the initial meeting, event of a dispute between the Parties cannot reach agreement thenwith respect to whether either Party has complied with its obligation under this Section 3.1, upon request of either Party, the matter then such dispute shall be referred to the dispute resolution procedure outlined resolved in accordance with Article 18. The consequences of any termination under this Section 11.3, which procedure shall be required to: 3.1 are set forth in Section 17.6.
(ae) determine whether there was, in fact, a material breach by AVROBIO of its diligence obligationRoche acknowledges that ArQule may subcontract, and (b) if it is determined that there was an uncured material breachpermitted to subcontract, 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 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 ArQule's obligations under this Section 3.3Agreement. However, prior to entering into any material subcontracts, ArQule shall first solicit the advice and input of Roche with respect to such subcontract.
Appears in 1 contract
Diligence. AVROBIO 7.1 The Parties acknowledge that failure to use their respective Diligent Efforts in Development and/or Commercialization of a Collaboration Product will diminish the value of this Agreement to both HGS and GSK. Accordingly, HGS and GSK shall each use Commercially Reasonable its respective Diligent Efforts to Develop perform the obligations assigned to each Party under the Agreement.
7.2 Each Party shall perform, or cause to be performed, any and Commercialize one or more Licensed Products all of its obligations as set forth in the United States this Agreement, including, without limitation, those obligations identified in this Article 7, in good scientific manner and in compliance in all material respects with all applicable laws.
7.3 The Parties will work together, through either the Major European Countries. In additionJDC, the RJMC, the GMJC or the JMC, as applicable, to reduce costs associated with the Development, Manufacturing, and without limiting the generality of the foregoing, AVROBIO shall initiate an IND-enabling pharmacology/toxicology study Commercialization of a Licensed Product within Collaboration Product, where possible, consistent with the terms of this Agreement and applicable Law, in order to maximize Net Profits. [***] of the Effective DateINDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. In the event that BioMarin believes AVROBIO is in 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.
7.4 Should a Party materially fail to apply its respective Diligent Efforts as required under this Section 7, then such failure to use Diligent Efforts shall be considered a material breach of its obligation this Agreement and the non-breaching Party shall have the right to terminate the rights granted to the breaching Party under Article 2 in accordance with Article 12.
7.5 In addition to other diligence requirements in this Article 7, a Party shall use Commercially Reasonable Diligent Efforts under this Section 3.3, then BioMarin may so notify AVROBIO to Commercialize the Collaboration Product 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 the extent the Collaboration Product is not being Commercialized by both Parties in such material breach of such diligence obligationcountry. 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 Should 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 Party not AVROBIO is in material breach of exercise its obligations under this Section 3.3 for an additional 7.5 with respect to [***] after such initial meeting. If after such [***] period following the initial meeting], the Parties cannot reach agreement then, upon request of either other Party shall have the right to terminate the other Party, the matter shall be referred ’s rights with respect to the dispute resolution procedure outlined Collaboration Product under Section 11.3this Agreement in that respective country or in the case of the country in the European Union, which procedure shall be required to: (a) determine whether there wasthat Region, 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)accordance with Section 12.3. If such procedure determines that there was a material 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.ARTICLE 8 REGULATORY MATTERS
Appears in 1 contract
Samples: Co Development and Commercialization Agreement (Human Genome Sciences Inc)
Diligence. AVROBIO will (a) During the Research Term, Aventis shall use Commercially Reasonable Efforts * to perform its Research obligations in accordance with the Research Plan. During the Term, Aventis agrees to use * to Develop and Commercialize Collaboration Products.
(b) The Parties agree that any Target presented by Avalon to the Research Committee in accordance with Section 3.4 which is not accepted by the Research Committee as a DRG within * shall not become a DRG or be included in the Research Program, and all rights to such Target shall remain with Avalon.
(c) The Parties agree that a DRG shall become a Reversion Target in the event of one or more Licensed Products of the following:
(i) if within * after a Target that is identified by Avalon during the Research Term is accepted by the Research Committee for inclusion in the United States Research Program as a DRG, such DRG is not selected as a SQT; or * The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(ii) if within * after a Target is selected as a DRG, (and assuming that Aventis subsequently selects it as an SQT), such DRG is not selected as an Advanced SQT; or
(iii) if Aventis determines not to Develop or to continue to Develop a Collaboration Product for an Advanced SQT; or
(iv) if Aventis does not use * to Develop and Commercialize Collaboration Products with respect to a selected Advanced SQT; or
(v) if, for any reason, Aventis determines not to Develop or to discontinue Development of a DRG.
(d) All rights to Reversion Targets shall revert to Avalon and Avalon may use any such Reversion Targets for any purpose, and may license Reversion Targets to Third Parties or collaborate with Third Parties with respect to Reversion Targets.
(e) With respect to each SQT and each Advanced SQT that becomes a Reversion Target, Aventis shall provide Avalon with the pre-clinical information and data (“Aventis Target Technology”) in the Major European CountriesControl of Aventis at the time such Target becomes a Reversion Target with respect to such Reversion Target that is useful for identifying Reversion Products by use of such Reversion Targets and the non-exclusive right and license to use and to sublicense such Aventis Target Technology with respect to Reversion Targets, provided that in no event shall Aventis Target Technology include any information or data relating to compounds, molecules or antibodies. In addition, * The asterisk denotes the confidential portions of this document that have been omitted and without limiting filed separately with the generality Securities and Exchange Commission pursuant to Rule 406 of the foregoingSecurities Act of 1933, AVROBIO shall initiate an IND-enabling pharmacology/toxicology study of a Licensed Product within [***] of the Effective Date. In the event that BioMarin believes AVROBIO is in material breach of its obligation to use Commercially Reasonable Efforts under this Section 3.3, 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 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 3.3amended.
Appears in 1 contract
Samples: Collaboration and License Agreement (Avalon Pharmaceuticals Inc)
Diligence. AVROBIO Subject to Chiesi’s compliance with Section 5.3, Protalix will use Commercially Reasonable Efforts to carry out the Development Plan in order to Develop and Commercialize one or more the Licensed Products Product in the United States and Field in the Major European CountriesTerritory (subject to Section 3.2(d)). In additionSubject to Protalix’s compliance with Section 3.6(c), and without limiting the generality of the foregoing, AVROBIO shall initiate an IND-enabling pharmacology/toxicology study of a Licensed Product within [***] of the Effective Date. In the event that BioMarin believes AVROBIO is in material breach of its obligation to Chiesi will use Commercially Reasonable Efforts under 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 Licensed Product 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 3.33.5: (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, then BioMarin may so notify AVROBIO conditioned or delayed) to provide its legal opinion as to whether a judge or jury would be highly unlikely to conclude, in writingexercising 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 notice shall provide available details regarding the basis law firm concludes could reasonably be issued within eighteen (18) months of the anticipated Regulatory Approval for its belief and specifying that 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. The Parties acknowledge and agree that (x) all communications with such law firm with respect to the foregoing, such law firm’s related work product, and such opinion (the “Diligence Breach NoticePrivileged Materials”) 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 privileged and confidential and shall not be disclosed to terminate anyone other than the 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 pursuant Agreement; provided that such Party seeks the highest level of confidential treatment for such Privileged Materials and limits the disclosure to Section 8.2. If AVROBIO provides a responsethe portion of the Privileged Material reasonably necessary to enforce its rights under this Agreement, and (y) prior to engaging the law firm, the Parties shall then conduct an initial meeting within [***] after delivery enter into a reasonable and customary joint defense agreement or common interest agreement; provided that, for the avoidance of doubt, the failure of the Parties to enter into such a written report from AVROBIO to discuss in good faith joint defense agreement or common interest agreement shall not be construed or deemed as evidence of any waiver by any of the concerns raised by BioMarin and shall conduct such additional meetings as are reasonably necessary to reach agreement as to whether Parties of any applicable legal privilege or not AVROBIO is in material breach any of its obligations under or their rights in this Section 3.3 for Agreement, or as an additional [***] after such initial meeting. If after such [***] period following the initial meeting, the Parties canindication that an applicable legal privilege has not reach agreement then, upon request of either Party, the matter shall be referred attached 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 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 3.3any Privileged Materials.
Appears in 1 contract
Samples: Exclusive License and Supply Agreement (Protalix BioTherapeutics, Inc.)
Diligence. AVROBIO will use Commercially Reasonable Efforts AlgoRx shall exercise commercially reasonable efforts to Develop and Commercialize one develop, or more Licensed to license to a Third Party to develop, each of the AlgoRx Named Products in the United States and in the Major European Countries. In additionorder to retain such product as an AlgoRx Named Product, and without limiting the generality of the foregoing, AVROBIO shall initiate an IND-enabling pharmacology/toxicology study of a Licensed Product within [expend (or its licensee shall expend) at least ***] of the Effective Date. In the event that BioMarin believes AVROBIO is in material breach of its obligation to use Commercially Reasonable Efforts under this Section 3.3, 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 [* per ***] after receipt * in research and development to support such efforts per AlgoRx Named Product until Regulatory Approval is achieved; provided that the foregoing shall apply to only one AlgoRx Named Product in a closely-related class of such notice, provide a written report to BioMarin to justify why AVROBIO believes it is not in such material breach AlgoRx Named Products that are established by agreement of such diligence obligation. If no such report is the Parties as provided by AVROBIO by at the end of Section 2.3(a). PRL shall exercise commercially reasonable efforts to develop, or to license to a Third Party to develop, each of the PowderJect Named Products in order to retain such time periodproduct as an PowderJect Named Product, BioMarin and shall be permitted to terminate this Agreement pursuant to Section 8.2. If AVROBIO provides a response, the Parties expend (or its licensee shall then conduct an initial meeting within [expend) at least ***] * per **** in research and development to support such efforts per PowderJect Named Product until Regulatory Approval is achieved; provided that the foregoing shall apply to only one PowderJect Named Product in a closely-related class of PowderJect Named Products that are established by agreement of the Parties as provided at the end of Section 2.3(b). Twelve (12) months after delivery designation of such an Selectable Product as either an AlgoRx Named Product or a written report from AVROBIO PowderJect Named Product (and once every subsequent twelve-month period), the designating Party shall provide 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 other Party an annual summary of its diligence with respect to such product. If, with respect to a particular Named Product, the designating Party (or its Affiliate or sublicensee) has, during the applicable twelve-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 3.3 for an additional [***] after 2.4(c) with respect to such initial meetingNamed Product. If after such [***] period following the initial meetingdesignating Party (or its Affiliate or sublicensee) has not expended the required amount of development funding on, the Parties canor is not reach agreement then, upon request of either Party, the matter shall be referred otherwise continuing to the dispute resolution procedure outlined under Section 11.3, which procedure shall be required to: (a) determine whether there was, in factuse commercially reasonable efforts to develop, a material breach by AVROBIO of its diligence obligationparticular Named Product, and (b) if it is determined that there was an uncured material breach, specify what additional efforts AVROBIO must undertake then such Named Product shall cease to cure such breachbe the designating Party's Named Product, and the time period during which non-designating Party shall have the co-exclusive rights to pursue such efforts must product and shall also be commenced and completed (which time period shall be commercially reasonable). If free to designate such procedure determines that there was a material breach product as its own Named Product under the above terms 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 3.32.3.
Appears in 1 contract