Common use of Backup Compounds Clause in Contracts

Backup Compounds. If, at any time prior to obtaining Regulatory Approval for a Licensed Product that contains the Lead Compound, Anteris determines to discontinue all further Development of the Lead Compound based on any technical or scientific reason (such as, by way of example only and not limitation, unsatisfactory results related to formulation, pharmacokinetics, safety, or tolerability or issues relating to length of market exclusivity), Anteris shall have the right to substitute a Backup Compound for the Lead Compound in accordance with this Section 4.5. (a) If Anteris makes such a determination, it shall give written notice of such determination to vTv (which notice may be given to vTv’s JAC members) and the Parties shall meet within thirty (30) days after vTv’s receipt of such notice, or such later date as may be agreed by the Parties. If requested by Anteris, the Parties will meet through the JAC at a specially convened meeting of the JAC. Prior to such meeting, vTv shall provide to Anteris information relating to all Backup Compounds that are identified by vTv as Controlled by vTv and not licensed to a Third Party or the subject of an active vTv Development program (and thus available for licensing to Anteris hereunder), including data and reports from non-clinical studies and Clinical Trials (if any), CMC data and other technical data and information relating to such Backup Compounds, that Anteris or vTv considers to be reasonably necessary for Anteris to assess such Backup Compounds and make an informed decision about substituting a Backup Compound for the Lead Compound. All such information provided to Anteris shall be the Confidential Information of vTv and subject to the terms of Article 11. At their meeting, the Parties shall review and discuss such information and the potential Backup Compounds and shall agree upon a Backup Compound to replace the Lead Compound, such agreement not to be unreasonably withheld, conditioned, or delayed. (b) The Backup Compound that is agreed by the Parties to replace the Lead Compound shall automatically be deemed to be a Licensed Compound under this Agreement and the Lead Compound shall automatically cease to be included as a Licensed Compound under this Agreement. Upon replacement of the Lead Compound with such Backup Compound, Anteris’ license under Section 2.1 with respect to the Lead Compound shall terminate without any further action by the Parties and, subject to the terms and conditions of this Agreement, including Section 2.6, all rights to the Lead Compound shall revert to vTv, and Anteris shall transfer and assign to vTv ownership of (i) any data and Regulatory Filings relating to the Lead Compound, and (ii) any quantities of the Lead Compound that Anteris has on hand at such time, in each case ((i) and (ii)) that are owned by Anteris at such time. Notwithstanding the foregoing, Anteris shall retain the right to use, access and reference such data and Regulatory Filings for purposes of and in connection with the Development, manufacture, Commercialization and other Exploitation of the Backup Compound and Licensed Products. (c) Within thirty (30) days following the Parties’ agreement on a Backup Compound, vTv shall (i) conduct a technology transfer to Anteris of complete and accurate copies, in electronic form where possible, of all vTv Know-How in existence at such time, including 15. preclinical and clinical data, regulatory data and communications, CMC data, and manufacturing processes and relationships (including Know-How pertaining to ongoing formulation development) relating to such Backup Compound or otherwise necessary for the research, Development, manufacture, Commercialization and other Exploitation of the Licensed Compound and Licensed Products, and (ii) provide to Anteris [***]. In connection with such transfer, vTv shall reasonably assist Anteris and its designee(s) in the use and understanding of such vTv Know-How and shall provide reasonable technical assistance, and make its technical personnel reasonably available to Anteris. vTv will bear all internal and out-of-pocket costs of providing such technical assistance for up to [***] hours of assistance, and Anteris will reimburse vTv any internal costs (at an hourly rate of $[***]) and out-of-pocket costs incurred in providing such technical assistance in excess of [***] hours. Following the initial technology transfer, if vTv develops or otherwise comes to Control any Know-How specifically relating to such Backup Compound or necessary for the research, Development, manufacture, Commercialization and other Exploitation of the Licensed Compound and Licensed Products, vTv will, upon Anteris’ request (which request Anteris may make no more than [***] every twelve (12) months), provide a summary of such Know-How to Anteris (through the JAC or otherwise) and, at Anteris’ request, vTv will transfer or otherwise make available to Anteris all such Know-How requested by Anteris; provided that Anteris reimburses vTv any internal costs (at an hourly rate of $[***]) and out-of-pocket costs incurred in transferring or otherwise making available such Know-How.

Backup Compounds. If, at (a) At any time prior and from time to obtaining Regulatory Approval time during the [***] period after the exercise of an Option, if the JSC determines in good faith that there is a bona fide scientific reason to do so, the JSC may direct Molecular Partners (i) to identify replacement DARPin Domains for any AGN DARPin Domain for the applicable Licensed Target Combination, or (ii) to optimize any AGN DARPin Domain or Product Candidate for such Licensed Target Combination, by modifying the nucleic or amino acid sequence (through the replacement, insertion or deletion of one or more nucleotides or amino acids, respectively, of such sequence) of an AGN DARPin Domain. Any resulting DARPin Compound generated by Molecular Partners that Binds each Collaboration Target of the Licensed Target Combination shall be deemed a “Backup Compound”, and Allergan may select [***] such Backup Compounds as Licensed Compounds (“Designated Backup Compounds”). Following identification and production of a Backup Compound, Molecular Partners shall promptly deliver such Backup Compound and a reasonably detailed summary of Information related thereto to Allergan. The DARPin Domains in such Designated Backup Compounds will be considered AGN DARPin Domains. (b) Backup Compounds will not include any MP DARPin Domains, or any DARPin Domains that Molecular Partners is researching or developing in an internal program or in collaboration with or for a Licensed Product that contains Third Party at the Lead Compound, Anteris determines to discontinue all further Development time of the Lead Compound based on any technical or scientific reason JSC’s request. (such as, by way of example only and not limitation, unsatisfactory results related to formulation, pharmacokinetics, safety, or tolerability or issues relating to length of market exclusivityc) Notwithstanding Section 5.7(a), Anteris if the JSC directs Molecular Partners to modify an AGN DARPin Domain or Product Candidate under Section 5.7(a)(ii), Molecular Partners shall have the right either (i) to substitute a Backup Compound for conduct such modification or (ii) to decline to conduct such activities and to grant Allergan the Lead Compound right to do so in strict accordance with this Section 4.5. (a) If Anteris makes such a determination, it shall give written notice of such determination to vTv (which notice may be given to vTv’s JAC members) and the Parties shall meet within thirty (30) days after vTv’s receipt of such notice, or such later date as may be plan agreed by the Parties. If requested by AnterisIn case (ii), Allergan shall promptly conduct such activities, solely as set forth in the Parties will meet through the JAC at a specially convened meeting of the JAC. Prior to such meetingplan, vTv and shall provide to Anteris information relating to Molecular Partners with all Backup Compounds that are identified by vTv as Controlled by vTv and not licensed to a Third Party or the subject of an active vTv Development program (and thus available for licensing to Anteris hereunder), including data and reports Information resulting from non-clinical studies and Clinical Trials (if any), CMC data and other technical data and information relating to such Backup Compounds, that Anteris or vTv considers to be reasonably necessary for Anteris to assess such Backup Compounds and make an informed decision about substituting a Backup Compound for the Lead Compoundactivities promptly after completion thereof. All such information provided to Anteris Information shall be deemed MP Core Inventions, and any DARPin Compound generated by Allergan that Binds each Collaboration Target of the Confidential Information of vTv and subject to the terms of Article 11. At their meeting, the Parties shall review and discuss such information and the potential Backup Compounds and shall agree upon Licensed Target Combination will be deemed a Backup Compound to replace the Lead Compound, such agreement not to be unreasonably withheld, conditioned, or delayed. (bd) The Backup Compound that is agreed by the Parties Molecular Partners shall not be obligated to replace the Lead Compound shall automatically be deemed to be a Licensed Compound under this Agreement and the Lead Compound shall automatically cease to be included as a Licensed Compound under this Agreement. Upon replacement of the Lead Compound with such Backup Compound, Anteris’ license under Section 2.1 with respect to the Lead Compound shall terminate without any further action by the Parties and, subject to the terms and conditions of this Agreement, including Section 2.6, all rights to the Lead Compound shall revert to vTv, and Anteris shall transfer and assign to vTv ownership of (i) any data and Regulatory Filings relating to the Lead Compound, and (ii) any quantities of the Lead Compound that Anteris has on hand at such time, in each case ((i) and (ii)) that are owned by Anteris at such time. Notwithstanding the foregoing, Anteris shall retain the right to use, access and reference such data and Regulatory Filings for purposes of and in connection with the Development, manufacture, Commercialization and other Exploitation of the Backup Compound and Licensed Products. (c) Within thirty (30) days following the Parties’ agreement on a Backup Compound, vTv shall (i) conduct a technology transfer to Anteris of complete and accurate copies, in electronic form where possible, of all vTv Know-How in existence at such time, including 15. preclinical and clinical data, regulatory data and communications, CMC data, and manufacturing processes and relationships (including Know-How pertaining to ongoing formulation development) relating to such Backup Compound or otherwise necessary for the research, Development, manufacture, Commercialization and other Exploitation of the Licensed Compound and Licensed Products, and (ii) provide to Anteris [***]. In connection with such transfer, vTv shall reasonably assist Anteris and its designee(s) in the use and understanding of such vTv Know-How and shall provide reasonable technical assistance, and make its technical personnel reasonably available to Anteris. vTv will bear all internal and out-of-pocket costs of providing such technical assistance for up to [***] hours of assistance, and Anteris will reimburse vTv any internal costs (at an hourly rate of $[***]) and out-of-pocket costs incurred in providing such technical assistance in excess of [***] hours. Following the initial technology transfer, if vTv develops or otherwise comes to Control any Know-How specifically relating to such Backup Compound or necessary for the research, Development, manufacture, Commercialization and other Exploitation of the Licensed Compound and Licensed Products, vTv will, upon Anteris’ request (which request Anteris may make no devote more than [***] every twelve FTE per year to conduct activities under this Section 5.7 for each Licensed Target Combination. Allergan shall reimburse Molecular Partners’ expenses to conduct such activities, at the FTE Rate, pursuant to Section 9.3. (12e) monthsIn addition to the sequence modification rights described in Section 5.7(a), provide a summary of such Know-How (i) the JSC may direct Allergan to Anteris (through the JAC perform Modifications to any AGN DARPin Domain or otherwise) Product Candidate and, if so directed, Allergan shall perform such Modifications subject to the oversight of the JSC and (ii) Allergan may, in its sole discretion, not subject to oversight by the JSC, and at Anteris’ requestany time during the Term, vTv will transfer Modify any AGN DARPin Domain or otherwise make available to Anteris all such Know-How requested by AnterisProduct Candidate; provided that Anteris reimburses vTv any internal costs (Allergan shall update Molecular Partners, during the JSC Term, at an hourly rate its next regularly scheduled meeting following the completion of $such Modification, and after the JSC Term, via the [***]) and out-of-pocket costs incurred ] development reports under Section 5.2(d), regarding such Modification (unless Allergan has a compelling business justification to delay such update, in transferring or otherwise making available such Know-How.which case it

Backup Compounds. If2.5.3.1. Alnylam will periodically provide to the JSC updates regarding the status of potential Backup Products, if any, for discussion pursuant to Section 5.4.1(a). 2.5.3.2. In the event that Alnylam determines, following discussion pursuant to Section 5.4.1(a) and subject to its diligence obligations under Section 2.4.2, to discontinue Development of ALN-TTR02 or ALN-TTRsc prior to receipt of Regulatory Approval therefor in the Alnylam Territory, Alnylam will provide written notice thereof to Genzyme within [**] days following such determination. 2.5.3.3. In the event that Alnylam, at its election following discussion pursuant to Section 5.4.1(a), intends to bring forward a Backup Compound as a substitute Licensed Product for a product that has been discontinued under Section 2.5.3.2, Alnylam will provide Genzyme with written notice thereof, together with a statement detailing the results and data of any pre-clinical or Clinical Studies for such proposed Backup Compound. Genzyme will have [**] days following the receipt of such notice and statement to review the proposed Backup Compound and to decide whether to include such Backup Compound as a Licensed Product under this Agreement. In the event that Genzyme notifies Alnylam within such [**] day period that it desires to include such proposed Backup Compound as a Licensed Product under this Agreement, such proposed Backup Compound will thereafter become a Licensed Product for all purposes of this Agreement. Notwithstanding the foregoing, if Alnylam brings forward a Backup Compound as a substitute Licensed Product for a product that has been discontinued under Section 2.5.3.2, without providing Genzyme with the written notice and information required by this Section 2.5.3.3, such Backup Compound shall automatically become a Licensed Product for all purposes of this Agreement until such time as Genzyme notifies Alnylam in writing that it does not wish such Backup Compound to be a Licensed Product, in which case such Backup Compound shall cease to be a Licensed Product for all purposes of this Agreement from the date of such notice. If a Backup Compound becomes a Licensed Product pursuant to this Section 2.5.3, the Licensed Product for which Development has been discontinued that is being replaced by such Backup Compound shall cease to be a Licensed Product for the purposes of this Agreement. 2.5.3.4. In the event that Genzyme determines, subject to its obligations under Section 2.4.1, to discontinue Development of ALN-TTR02 prior to obtaining receipt of Regulatory Approval for a Licensed Product that contains ALN-TTR02 in the Lead CompoundGenzyme Territory, Anteris determines to discontinue all further but Alnylam has not discontinued Development of ALN-TTR02 in the Lead Compound based on any technical or scientific reason (such asAlnylam Territory prior to receipt of Regulatory Approval for ALN-TTR02 in the Alnylam Territory, by way of example only and not limitation, unsatisfactory results related to formulation, pharmacokinetics, safety, or tolerability or issues relating to length of market exclusivity), Anteris shall have the right to substitute a Backup Compound for the Lead Compound in accordance Genzyme may provide Alnylam with this Section 4.5. (a) If Anteris makes such a determination, it shall give written notice of such determination its desire to vTv (which notice may be given abandon Development of ALN-TTR02 in the Genzyme Territory and to vTv’s JAC members) and pursue an alternative siRNA Product that is an siRNA targeting the Parties shall meet within thirty (30) days after vTvhuman TTR gene formulated in an ▇▇▇▇ ▇▇▇▇▇ Nanoparticle Formulation. After Alnylam’s receipt of such notice, or Alnylam will provide Genzyme with any information in Alnylam’s possession that Genzyme may reasonably request regarding such later siRNA Products. After its evaluation of such information, Genzyme may, by providing written notice to Alnylam, cause any one of such siRNA Products to become a Licensed Product for all purposes of this Agreement from the date as of such notice, and may be agreed by Develop such siRNA Product for the PartiesGenzyme Territory; provided, however, that if Genzyme causes such an siRNA Product to become a Licensed Product, Alnylam shall have no obligation to Develop such siRNA Product in the Alnylam Territory pursuant to this Agreement. If requested such an siRNA Product becomes a Licensed Product pursuant to this Section 2.5.3.4, then (a) the licenses granted by Anteris, the Parties will meet through the JAC at a specially convened meeting of the JAC. Prior Alnylam to such meeting, vTv Genzyme with respect to ALN-TTR02 under this Agreement shall provide to Anteris information relating to all Backup Compounds that are identified by vTv as Controlled by vTv and not licensed to a Third Party or the subject of an active vTv Development program (and thus available for licensing to Anteris hereunder), including data and reports from non-clinical studies and Clinical Trials (if any), CMC data and other technical data and information relating to such Backup Compounds, that Anteris or vTv considers to be reasonably necessary for Anteris to assess such Backup Compounds and make an informed decision about substituting a Backup Compound for the Lead Compound. All such information provided to Anteris shall be the Confidential Information of vTv and subject to the terms of Article 11. At their meeting, the Parties shall review and discuss such information and the potential Backup Compounds and shall agree upon a Backup Compound to replace the Lead Compound, such agreement not to be unreasonably withheld, conditioned, or delayed. terminate; (b) The Backup Compound that is agreed by without limiting Genzyme’s obligations under Sections 2.4.1 and 4.1.1 as to the Parties Development and Commercialization of Licensed Products generally, Genzyme’s obligations to replace the Lead Compound Develop and Commercialize ALN-TTR02 shall automatically be deemed to be a Licensed Compound under this Agreement and the Lead Compound shall automatically cease to be included as a Licensed Compound under this Agreement. Upon replacement of the Lead Compound with such Backup Compoundterminate, Anteris’ license including all obligations under Section 2.1 2, Section 3, and Section 4 with respect to ALN-TTR02; (c) the Lead Compound development milestone payment under Section 8.2(iv) shall terminate without any not be payable by Genzyme with respect to Alnylam’s or its Related Parties’ development of ALN-TTR02 if such development milestone payment has not become payable prior to Genzyme’s discontinuation of development of ALN-TTR02; (d) the JSC shall have no further action by the Parties and, subject responsibilities with respect to the terms and conditions of this Agreement, including Section 2.6, all rights to the Lead Compound shall revert to vTv, and Anteris shall transfer and assign to vTv ownership of (i) any data and Regulatory Filings decision making or governance relating to the Lead CompoundDevelopment or Commercialization of ALN-TTR02, but Alnylam shall continue to provide informational updates to Genzyme regarding ALN-TTR02 to the extent such information is reasonably useful or necessary to Genzyme with regard to the Development or Commercialization of Licensed Products in the Genzyme Territory; (e) Alnylam’s continued Development of ALN-TTR02 shall continue to count toward the satisfaction of Alnylam’s obligations under Section 2.4.2; and (iif) any quantities Alnylam’s obligations set forth in Section 5.7.1 shall cease to apply with respect to Alnylam’s licensing of the Lead Compound that Anteris has on hand at such time, in each case ((i) and (ii)) that are owned by Anteris at such time. Notwithstanding the foregoing, Anteris shall retain the right to use, access and reference such data and Regulatory Filings for purposes of and in connection with the Development, manufacture, Commercialization and other Exploitation of the Backup Compound and Licensed ProductsALN-TTR02. (c) Within thirty (30) days following the Parties’ agreement on a Backup Compound, vTv shall (i) conduct a technology transfer to Anteris of complete and accurate copies, in electronic form where possible, of all vTv Know-How in existence at such time, including 15. preclinical and clinical data, regulatory data and communications, CMC data, and manufacturing processes and relationships (including Know-How pertaining to ongoing formulation development) relating to such Backup Compound or otherwise necessary for the research, Development, manufacture, Commercialization and other Exploitation of the Licensed Compound and Licensed Products, and (ii) provide to Anteris [***]. In connection with such transfer, vTv shall reasonably assist Anteris and its designee(s) in the use and understanding of such vTv Know-How and shall provide reasonable technical assistance, and make its technical personnel reasonably available to Anteris. vTv will bear all internal and out-of-pocket costs of providing such technical assistance for up to [***] hours of assistance, and Anteris will reimburse vTv any internal costs (at an hourly rate of $[***]) and out-of-pocket costs incurred in providing such technical assistance in excess of [***] hours. Following the initial technology transfer, if vTv develops or otherwise comes to Control any Know-How specifically relating to such Backup Compound or necessary for the research, Development, manufacture, Commercialization and other Exploitation of the Licensed Compound and Licensed Products, vTv will, upon Anteris’ request (which request Anteris may make no more than [***] every twelve (12) months), provide a summary of such Know-How to Anteris (through the JAC or otherwise) and, at Anteris’ request, vTv will transfer or otherwise make available to Anteris all such Know-How requested by Anteris; provided that Anteris reimburses vTv any internal costs (at an hourly rate of $[***]) and out-of-pocket costs incurred in transferring or otherwise making available such Know-How.