Contract
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Exhibit 10.2
RESTRICTED
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Contents
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Collaboration and Licence Agreement (the "Agreement")
Dated May 4,2023 (the "Execution Date")
Between:
BicycleTx and Bayer are referred to herein individually as a "Party" and collectively as the "Parties".
Recitals:
Now, therefore, in consideration of the mutual promises and conditions set out in this Agreement, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
1 | Definitions |
1.1 | "Accounting Standards" means, with respect to a Party and its Affiliates, either: |
(a) | the International Financial Reporting Standards (IFRS) in respect of Bayer; or |
(b) | the United States Generally Accepted Accounting Principles (US GAAP) in respect of BicycleTx, |
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in either case ((a) or (b)) that are used by the relevant Party at the applicable time, and as consistently applied by such Party or any of its Affiliates;
1.2 | "Acquisition" means with respect to Bayer: |
(c) | that Bayer or any of its Affiliates consolidates or combines with or merges or reorganises into another corporation or entity not being an Affiliate of Bayer, or any corporation or entity not being an Affiliate of Bayer, consolidates or combines with or merges or reorganised into Bayer or any of its Affiliates, or there is a share exchange or other similar transaction, in each event pursuant to a transaction in which more than fifty percent (50%) of the total voting power of the outstanding voting securities of the surviving, purchasing or continuing entity (or, if applicable, the ultimate parent of such entity) is held by the Persons which held at least fifty percent (50%) of the outstanding voting securities of Bayer or its respective Affiliate (or, if applicable, the ultimate parent of such entity) preceding such consolidation, combination, reorganisation or merger; or |
1.3 | "Active Internal Program" means [***]; |
1.4 | "Acquired Principal Assets" has the meaning set forth in Clause 1.2(d); |
1.5 | "Additional Nominated Target" has the meaning set forth in Clause 2.4; |
1.6 | "Additional Nominated Target Availability Notice" has the meaning set forth in Clause 2.4; |
1.7 | "Additional Nominated Target Research Plan" has the meaning set forth in Clause 2.4; |
1.8 | "Additional Target Nomination Effective Date" has the meaning set forth in Clause 2.4; |
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1.10 | "Agreement" has the meaning set forth in the preamble hereto; |
1.11 | "Alliance Manager" has the meaning set forth in Clause 3.6; |
1.14 | "Bayer Background Patents" means Patents which Cover Bayer Background IP, including [***] and any Patent claiming priority, issued or granted from such Patents; |
1.15 | "Bayer Competitive Activities" has the meaning given to it in Clause 5.3.5; |
1.16 | "Bayer Exclusivity Obligations" has the meaning set forth in Clause 5.3.3; |
1.17 | "Bayer Indemnitees" has the meaning set forth in Clause 11.2; |
1.18 | "Bayer In-Licence Agreement" has the meaning set forth in Clause 7.6.3(c) |
1.19 | "Bayer Linker" means a Linker in which [***]; |
1.20 | "Bayer Linker Know-How" means any Know-How Controlled by Bayer that relates to a Linker; |
1.21 | "Bayer Linker Patents" means Patents which Cover Bayer Linker Know-How; |
1.22 | "Bayer New Affiliates" has the meaning given to it in Clause 5.3.3; |
1.23 | "Bayer Non-RLT Collaboration Program Fee" has the meaning set forth in Clause 7.3.2; |
1.24 | "Bayer Non-RLT Option" has the meaning set forth in Clause 4.2.1; |
1.25 | "Bayer Non-RLT Option Fee" has the meaning set forth in 7.3.1; |
1.26 | "Bayer Non-RLT Program" has the meaning set forth in Clause 4.2.1; |
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1.27 | "Bayer Sole IP" has the meaning set forth in Clause 8.1.2(e); |
1.28 | "Bayer Sole Patents" means Patents which Cover the Bayer Sole IP; |
1.29 | "Bayer Specific Collaboration IP" has the meaning set forth in Clause 8.1.2(b); |
1.30 | "Bayer Specific Collaboration Patents" means Patents which Cover the Bayer Specific Collaboration IP; |
1.31 | "BCC" means a compound that has been generated or optimised under the Research Activities of the Research Plan comprising [***]; |
1.32 | "Bicycle" means a monomeric peptide or peptide derivative crosslinked via a central scaffold to form a conformationally constrained structure with more than one cyclic component; |
1.33 | "BicycleTx" has the meaning set forth in the preamble hereto; |
1.35 | "BicycleTx Background Patents" means Patents which Cover BicycleTx Background IP, including [***] and any Patent claiming priority, issued or granted from such Patents; |
1.36 | "BicycleTx Competitive Activities" has the meaning given to it in Clause 5.3.2; |
1.37 | "BicycleTx Bicycle IP" has the meaning set forth in Clause 8.1.2(a); |
1.38 | "BicycleTx Bicycle Patents" means Patents which Cover BicycleTx Bicycle IP; |
1.39 | "BicycleTx Exclusivity Obligations" has the meaning set forth in Clause 5.3.1; |
1.40 | "BicycleTx Indemnitees" has the meaning set forth in Clause 11.1; |
1.41 | "BicycleTx New Affiliates" has the meaning given to it in Clause 5.3.2; |
1.42 | "BicycleTx Sole IP" has the meaning set forth in Clause 8.1.2(e); |
1.43 | "BicycleTx Sole Patents" means Patents which Cover BicycleTx Sole IP; |
1.44 | "BicycleTx Specific Collaboration IP" has the meaning set forth in Clause 8.1.2(a); |
1.45 | "BicycleTx Specific Collaboration Patents" means Patents which Cover BicycleTx Specific Collaboration IP; |
1.46 | "BicycleTx Trademarks" means the Trademarks listed in Schedule 3; |
1.47 | "BRC" means a compound that has been generated or optimised under the Research Activities of the Research Plan comprising [***]; |
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1.48 | "Breach Notice" has the meaning set forth in Clause 12.2.1; |
1.49 | "Business Day" means a day other than a Saturday or Sunday on which banking institutions in London, England, in Berlin, Germany and Basel, Switzerland are open for business; |
1.52 | "Change of Control" means with respect to a Party: |
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1.54 | "Clinical Trial" means a human clinical study: |
(a) | in which a Licensed Product is administered to human subjects; and |
(b) | that is designed to: |
1.55 | "Co-Chair(s)" has the meaning set forth in Clause 3.1.1; |
1.57 | "Collaboration Phage Display Platform IP" has the meaning set forth in Clause 8.1.2(a); |
1.58 | "Collaboration Program" has the meaning set forth in Clause 2.1; |
1.61 | "Company Core Data Sheet" means the global reference labelling document used to direct the content of country-specific labelling for Licensed Products; |
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1.65 | "DC Preparation Period" has the meaning set forth in Clause 4.1.4; |
1.67 | "Development Candidate" means a BRC or Non-BRC (as applicable) that has been elected for further Development as a Licensed Product pursuant to Clause 4.1.6; |
1.68 | "Development Candidate Election" has the meaning set forth in Clause 4.1.6; |
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1.69 | "Development Candidate IP" has the meaning set forth in Clause 8.1.2(b); |
1.70 | "Development Candidate Patents" means Patents which Cover Development Candidate IP; |
1.71 | "Development Milestone Event" has the meaning set forth in Clause 7.4.1; |
1.72 | "Development Milestone Payment" has the meaning set forth in Clause 7.4.1; |
1.73 | "Disclosing Party" has the meaning set forth in Clause 9.1; |
1.74 | "Dispute" has the meaning set forth in Clause 13.5; |
1.75 | "Dollars" or "$" means United States Dollars; |
1.77 | "Effective Date" has the meaning set forth in paragraph 1(a) of Schedule 6 hereto; |
1.78 | "EMA" means the European Medicines Agency and any successor agency(ies) or authority having substantially the same function; |
1.79 | "European Major Market" means each of the [***]; |
1.80 | “Execution Date” has the meaning set forth in the preamble hereto; |
1.82 | "Extended Development Term" has the meaning set forth in Clause 4.1.3; |
1.83 | "Extended PCC Research Term" has the meaning set forth in Clause 4.1.3; |
1.84 | "Extended Research Term" has the meaning set forth in Clause 2.6.2; |
1.85 | "FDA" means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function; |
1.87 | "Field" means all therapeutic (including the treatment or prevention of any disease) and diagnostic uses for humans or animals; |
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1.89 | "FPFD" means, with respect to a Licensed Product and a Clinical Trial, the first dosing of the first patient with such Licensed Product in such Clinical Trial; |
1.91 | "Futility Decision" means a decision that a compound or product is unlikely to achieve the [***]; |
1.92 | "Gatekeeper" has the meaning set forth in Clause 2.5.4; |
1.94 | "Hit Bicycle" means a Bicycle that binds to the applicable Target of the respective Collaboration Program; |
1.95 | "IND" means an application filed with a Regulatory Authority for authorization to commence Clinical Trials, including: |
1.96 | "Indemnification Claim Notice" has the meaning set forth in Clause 11.3; |
1.97 | "Indemnified Party" has the meaning set forth in Clause 11.3; |
1.98 | "Indemnifying Party" has the meaning set forth in Clause 11.3; |
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1.99 | "Indication" means [***]. For clarity, [***]: |
1.100 | "Initial Research Term" has the meaning set forth in Clause 2.6.1; |
1.101 | "Initial Target(s)" means each of the targets set forth in Schedule 1; |
1.102 | "Initial Target Substitute" has the meaning set forth in Clause 2.5.1; |
1.103 | "Initial Target Substitution Notice" has the meaning set forth in Clause 2.5.1; |
1.104 | "Insolvency Event" has the meaning set forth in Clause 12.4; |
1.107 | "IP Challenge" has the meaning set forth in Clause 12.2.2; |
1.108 | "Joint Collaboration IP" has the meaning set forth in Clause 8.1.2(e); |
1.109 | "Joint Collaboration Patents" means Patents which Cover Joint Collaboration IP; |
1.110 | "JPC" has the meaning set forth in Clause 3.8; |
1.111 | "JRC" has the meaning set forth in Clause 3.1.1; |
1.112 | "JRC Member" has the meaning set forth in Clause 3.1.1; |
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1.114 | [***]; |
1.116 | "Licensed IP" means the BicycleTx Background IP, BicycleTx Sole IP and the BicycleTx Specific Collaboration IP, excluding [***]; |
1.117 | "Licensed Non-RLT Product" means a product that contains or incorporates (i) a Licensed Compound, or (ii) a [***], that is a Non-BRC; |
1.118 | "Licensed Product" means a Licensed RLT-Product or a Licensed Non-RLT Product, as applicable; |
1.119 | "Licensed RLT-Product" means a product that contains or incorporates (i) a Licensed Compound, or (ii) a [***], that is a BRC whether in its radioactive or non-radioactive state; |
1.120 | "Linker" means any chemical matter bridging or capable of acting as a bridging moiety between the Bicycle and any other moiety; |
1.121 | "Linker Specific Collaboration IP" has the meaning set forth in Clause 8.1.2(c); |
1.122 | "Losses" has the meaning set forth in Clause 11.1; |
1.123 | "MAA" has the meaning set forth in Clause 1.76; |
1.124 | "Macrocyclic Peptide" means peptide or peptidomimetic structures comprising one or more rings spanning multiple amino acid residues; |
1.125 | "Major Market" means each of the [***]; |
1.128 | "Materials" has the meaning set forth in Clause 2.8.2; |
1.129 | [***]; |
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any Regulatory Authority, including all documents, data, and other information concerning Licensed Products, which are necessary for gaining Regulatory Approval to market and sell Licensed Product in the relevant jurisdiction; |
1.132.1 | [***]; |
1.132.2 | [***]; |
1.132.3 | [***]; |
1.132.4 | [***]; |
1.132.5 | [***]; and |
1.132.6 | [***]. |
[***]:
1.132.7 | [***]; |
1.132.8 | [***]; |
1.132.9 | [***]; |
1.132.10 | [***]; |
[***].
1.133 | "Nomination Fee" has the meaning set forth in Clause 7.2; |
1.134 | "Non-BRC" means a compound (i) comprising of one or more Bicycles that bind to a Target that (ii) does not contain a radionuclide [***]; |
1.135 | "Non-RLT Collaboration Program" has the meaning set forth in Clause 4.2.1; |
1.136 | "Non-RLT Option Period" has the meaning set forth in Clause 4.2.2; |
1.137 | "Non-Specific Collaboration IP" has the meaning set forth in Clause 8.1.2(d); |
1.138 | "Optimised Bicycle" means a Hit Bicycle that has [***]; |
1.139 | [***]; |
1.140 | "Party" and "Parties" has the meaning set forth in the preamble hereto; |
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1.143 | [***]; |
1.145 | "Phage Display Platform IP" means [***]; |
1.146 | "Phage Platform" means (a) [***], (b) [***], and (c) any improvements or enhancements to (a) and (b); |
1.149 | "Phase II Clinical Trial" means a Clinical Trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(b) or any of its foreign equivalents; |
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1.151 | "Pounds" or "GBP" or "£" means British pounds sterling; |
1.152 | "Product Labelling" means, with respect to a Licensed Product in a country or other jurisdiction in the Territory: |
1.154 | "Progress Report" has the meaning set forth in Clause 2.3.6; |
1.155 | "Publishing Notice" has the meaning set forth in Clause 9.5; |
1.156 | "Publishing Party" has the meaning set forth in Clause 9.59.5; |
1.157 | "Receiving Party" has the meaning set forth in Clause 9.1; |
1.158 | "Redacted Agreement" has the meaning set forth in Clause 9.2.29.2.2; |
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1.162 | "Research Activities" has the meaning set forth in Clause 2.2.1; |
1.163 | "Research Plan" has the meaning set forth in Clause 2.2.12.2.1; |
1.164 | "Research Term" means, in respect of each Collaboration Program, the Initial Research Term and any Extended Research Term or Extended PCC Research Term, as applicable; |
1.165 | "Royalty Patent" means [***]; |
1.166 | "Royalty Payment" has the meaning set forth in Clause 7.6.1(a); |
1.167 | "Royalty Term" has the meaning set forth in Clause 7.6.2; |
1.168 | "Rules" has the meaning set forth in Clause 13.6.2; |
1.169 | "Sales Milestone Event" has the meaning set forth in Clause 7.5.1; |
1.170 | "Sales Milestone Payment" has the meaning set forth in Clause 7.5.1; |
1.171 | "Scientific Program Lead" has the meaning set forth in Clause 3.5; |
1.173 | "Sold Principal Assets" has the meaning set forth in Clause 1.52; |
1.174 | "Sublicensee" means a Person, other than a Third Party Service Provider, who has been granted a sublicence by Bayer under the licence grants in Clause 6.1 as provided in Clause 6.5; |
1.175 | "Substitute Nominated Target" has the meaning set forth in Clause 2.5.2; |
1.176 | "Substitute Nominated Target Fee" has the meaning set forth in Clause 7.2.2; |
1.177 | "Substitute Target" means an Initial Target Substitute or a Substitute Nominated Target, as applicable; |
1.178 | "Substitute Target Availability Notice" has the meaning set forth in Clause 2.5.3; |
1.179 | "Substitute Target Research Plan" has the meaning set forth in Clause 2.5.3; |
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1.180 | "Target" means the Initial Targets, the Additional Nominated Target, and the Substitute Targets, in each case as applicable; |
1.181 | "target" means a protein identified by its gene name, UniProt ID and its amino acid sequence, or other similar information; |
1.182 | "Target Substitute Fee" has the meaning set forth in Clause 7.2.3; |
1.183 | "Term" has the meaning set forth in Clause 12.1; |
1.184 | "Terminated Asset" means, on a Collaboration Program-by-Collaboration Program basis, with respect to a Collaboration Program that is terminated by [***] under Clause 12 or expires pursuant to Clause 12.1.2, each Licensed Compound, Development Candidate and Licensed Product, that is the subject of such Collaboration Program; |
1.185 | "Terminated Target" means a Target that (i) is the subject of a Collaboration Program or, as applicable, a Bayer Non-RLT Program that has expired pursuant to Clause 12.1.2; (ii) is the subject of a Collaboration Program that has been terminated pursuant to Clause 12 where all other Collaboration Programs in respect of such Target have expired or been terminated pursuant to Clause 12; (iii)12.1.2 to which a Licensed Product is directed that has been terminated pursuant to Clause 12 where all other Licensed Products directed to such Target have expired or been terminated pursuant to Clause 12; (iv) has been terminated for any reason pursuant to Clause 12; or (v) has been substituted pursuant to Clause 2.5; |
1.186 | "Territory" means the entire world; |
1.187 | "Third Party" means any Person other than BicycleTx, Bayer and their respective Affiliates; |
1.188 | "Third Party Claims" has the meaning set forth in Clause 11.1; |
1.189 | "Third Party Infringement" has the meaning set forth in Clause 8.4.1; |
1.190 | "Third Party Service Provider" has the meaning set forth in Clause 6.6; |
1.193 | "United States" or "U.S.A." means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico); |
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1.194 | "Upfront Fee" has the meaning set forth in Clause 7.1; |
1.196 | "VAT" means: |
(a) | any tax imposed in compliance with the Value Added Tax Act 1994 or Directive 2006/112/EC; and |
(b) | any tax of a similar nature, wherever imposed); and |
1.197 | "Withholding Tax Action" has the meaning set forth in Clause 7.10.3. |
| |
2 | Collaboration Program and Research Activities |
2.1 | Collaboration Overview |
The Parties agree that, during the Research Term, each Party shall perform the applicable Research Activities for the purpose of developing Licensed Compounds and Licensed Products in respect of each Target for use in the Field. The Research Activities in respect of a Target shall each be a collaboration program between the Parties pursuant to a Research Plan (each a "Collaboration Program"). [***]. The Parties shall commence after the Effective Date two Collaboration Programs each directed against a different Initial Target. Subject to the provisions of this Agreement, Bayer may exercise its right to commence a third Collaboration Program directed against an Additional Nominated Target or to commence an additional Collaboration Program or Bayer Non-RLT Program per Target for the Development of Licensed Non-RLT Products.
2.2 | Research Plan |
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Target Substitute Fee (as applicable), each Party, as applicable, shall commence the Research Activities allocated to it under the Research Plan at Schedule 2 within [***] after the Effective Date and shall commence the Research Activities under any Additional Nominated Target Research Plan or Substitute Target Research Plan within [***] of the relevant Research Plan being mutually agreed. |
2.2.3 | During the Research Term, the Parties may amend the Research Plan in accordance with Clause 3.1.2(a). [***], this Clause 2.2.3 prevails and [***] |
2.2.5 | In no event shall BicycleTx be required to work on [***] Collaboration Programs at the same time during the Research Term, except where the JRC decides by unanimous vote that BicycleTx shall work on more than [***] Collaborations Programs at the same time. |
2.3 | Research Diligence Efforts and Reporting |
2.3.1 | The Parties shall perform the Research Activities in good scientific manner, in accordance with the terms of this Agreement, and in compliance with all Applicable Law. |
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any substantial difficulties or delays), results and next steps of such Research Activities at such JRC meetings. |
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2.4 | Additional Target Nomination Right |
2.5 | Target Substitution Rights |
For the avoidance of doubt, Bayer may only propose [***] Initial Substitute Target at a time.
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2.5.4 | Gatekeeper mechanism |
If either Party desires, at any time following the Effective Date, to make confidential inquiries regarding the availability of an Additional Nominated Target or a Substitute Target (i.e. through the process set forth in Clauses 2.4.1, 2.5.1, 2.5.2 and 2.5.3), such Party shall notify the other Party in writing thereof. As soon as reasonably practicable following receipt of such notice, and in any case within [***] following receipt of such notice, [***] shall engage an independent Third Party mutually agreeable to the Parties (the "Gatekeeper") for the purposes of performing the applicable functions set forth in Clauses 2.4.1 and 2.5.3, including (a) maintaining a list of Unavailable Targets, and (b) issuing the Substitute Target Availability Notice or the Additional Nominated Target Availability Notice. The costs of the Gatekeeper shall be [***]. Such engagement shall be on terms consistent with this Agreement and mutually agreeable to the Parties, including provisions relating to confidentiality. The identity of the Unavailable Targets shall be deemed the Confidential Information of BicycleTx, and the identity of the proposed Additional Nominated Target, Initial Target Substitute, and Substitute Nominated Target shall be deemed the Confidential Information of Bayer. Following the appointment of a Gatekeeper, (i) all references in Clauses 2.4.1, 2.5.1, 2.5.2 and 2.5.3 regarding disclosure by one Party to the other Party shall instead be deemed to refer to disclosure to or by the Gatekeeper by or to the applicable Party, mutatis mutandis, and (ii) BicycleTx shall notify the Gatekeeper of the Unavailable Targets promptly, but in no event later than [***] after any target becomes an Unavailable Target. Upon
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receipt of such notification, the Gatekeeper shall update the list of Unavailable Targets accordingly.
2.6 | Research Term |
2.6.1 | Subject to Clauses 2.6.2, 4.1.3, 4.1.4 and 12, each Collaboration Program in respect of: |
(in each case an "Initial Research Term").
2.7 | Supply of Bicycles |
2.7.2 | BicycleTx shall be permitted to use contract development and manufacturing organisations pursuant to Clause 6.6 for the purpose of its Manufacturing pursuant to Clause 2.7.1. |
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2.7.4 | For clarity, Bayer shall not use the Bicycles provided by or on behalf of BicycleTx to Bayer for purposes outside of this Agreement or in contravention of Applicable Law. |
2.8 | Supply of chemical chelates and radionuclide material |
2.8.3 | Each Party acknowledges that all Materials exchanged hereunder are experimental and their properties are not completely known. The receiving Party shall use, store and handle such Materials with prudence and appropriate caution and in accordance with the Applicable Law relating thereto. Unless agreed otherwise, any unused portion of the Materials shall be, at the providing Party's option, either returned to the providing Party at its cost or destroyed, provided, however, that such obligation shall not apply to the extent rights to the relevant Materials are obtained or retained by either Party pursuant to the express provisions of this Agreement. |
2.8.4 | Both Parties agree that animal welfare is considered important for ethical reasons as well as for the sake of quality of studies. If the Research Activities comprise in vivo testing, the Parties agree to apply high standards of animal care and shall in any event comply with the Applicable Law in that regard. |
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3 | Collaboration Management |
3.1 | Joint Research Committee |
3.1.1 | Formation |
Within [***] after the Effective Date, the Parties shall establish a joint research committee (the "JRC"). The JRC shall be comprised of an equal number of representatives from each of Bayer and BicycleTx. The JRC shall consist of up to [***] representatives from each of the Parties (a "JRC Member"). Each JRC Member shall have the requisite experience and seniority to enable such person to make decisions on behalf of the applicable Party with respect to the issues falling within the decision-making authority of the JRC. From time to time, each Party may substitute [***] or more of its JRC Members on written notice to the other Party. Each Party shall select from its JRC Members a representative who will chair the JRC jointly with the selected representative from the other Party (the "Co-Chairs"). Each Party may replace its Co-Chair from time to time by informing the other Party in writing. The Co-Chairs of the JRC shall not have any greater authority than any other JRC Members.
3.1.2 | Specific Responsibilities |
The JRC shall oversee the Research Activities undertaken in accordance with the applicable Research Plan for each Collaboration Program and serve as a consultative and information-exchange for the ongoing Collaboration Programs. In particular, the JRC shall:
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3.2 | General Provisions Applicable to the JRC |
3.2.1 | Meetings and Minutes |
The JRC shall hold meetings at such time as agreed between the Co-Chairs, but in no event less frequently than [***], approximately [***] every [***] during the Research Term. Subject to Clause 3.11, the JRC shall meet either in person or by tele-/videoconference with the venue of the in person meetings alternating between locations designated by BicycleTx and locations designated by Bayer. At least [***] the JRC Members shall meet in person, unless otherwise agreed by the Co-Chairs. The Alliance Manager shall be permitted to attend any such JRC meetings. The Co-Chairs of the JRC shall be responsible for calling meetings on no less than [***] notice, unless the JRC Members agree to convene on shorter notice. Each Party shall make all proposals for agenda items and shall provide all appropriate information with respect to such proposed items at least [***] in advance of the applicable meeting; provided that under exigent circumstances requiring input by the JRC, a Party may provide its agenda items to the other Party within a shorter period of time in advance of the meeting, and provided that the other Party will endeavour to prepare for such agenda item on short notice but will not be expected to provide its conclusive input or final opinion thereon. The Co-Chairs of the JRC (or their designee) shall prepare and circulate minutes of each meeting within [***] after the meeting for the Parties' review and approval. The Parties shall agree on the minutes of each meeting promptly, but in no event later than within [***] following circulation of the draft minutes.
3.2.2 | Procedural Rules |
The JRC shall have the right to adopt such standing rules as shall be necessary for its work, so long as such rules are not inconsistent with this Agreement. A quorum of the JRC shall exist whenever there is present at a meeting at least [***] JRC Members appointed by each Party. Representation by proxy shall be allowed. The JRC shall take action by unanimous decision at a meeting at which a quorum exists, with each Party having a single vote irrespective of the number of representatives of such Party in attendance as JRC Members, or by a written resolution signed by at least [***] JRC Member appointed by each Party.
3.2.3 | Non-Member Attendance |
Each Party may from time to time invite a reasonable number of participants, in addition to the JRC Members, to attend JRC meetings in a non-voting capacity; provided that:
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3.3 | Decisions |
3.3.1 | Decision Making Authority |
The JRC shall decide matters within its responsibilities pursuant to Clause 3.1.2.
3.3.2 | Consensus; Good Faith |
The JRC Members shall in good faith cooperate with one another and shall endeavour to seek agreement with respect to issues to be decided by the JRC.
3.3.3 | Final Decision Right; Dispute Resolution |
If the JRC cannot, or does not, reach consensus on an issue within its purview, then Bayer shall have final say on [***] provided that in exercising such final decision making authority, Bayer may not (a) [***] shall be mutually agreed between the Parties and not subject to [***] (b) amend the [***], the [***] or the [***] and in such event the status quo shall persist unless and until the Parties' mutually agree in writing, (c) require BicycleTx to work on more than [***] at the same time during the Research Term, (d) have final decision making authority on any matter which is [***], or (e) impose any requirement on BicycleTx to undertake obligations beyond those for which it is responsible or to forgo any of its rights under this Agreement, or require BicycleTx to violate any Applicable Law, ethical requirement, or any agreement it may have with any Third Party, or amend the terms and conditions of this Agreement.
3.4 | Limitations on Authority |
Each Party shall retain the rights, powers, and discretion granted to it under this Agreement and no such rights, powers, or discretion shall be delegated to or vested in the JRC unless such delegation or vesting of rights is expressly provided for in this Agreement. The JRC shall not have the power to amend, modify, or waive compliance with this Agreement, which may only be amended or modified as provided in Clause 13.8 or compliance with which may only be waived as provided in Clause 13.10.
3.5 | Scientific Program Lead |
Each Party shall appoint a project leader for each Collaboration Program who shall be responsible for the day-to-day dealings under the applicable Collaboration Program and shall be the primary point of contact for the other Party for the exchange of information relating to the operation and scientific matters with respect to the Research Activities of the applicable Collaboration Program (the "Scientific Program Lead"). The Scientific Program Leads shall report on the progress of the Collaboration
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Program for which they are the project leader to the JRC during the Research Term. Further, BicycleTx shall provide the Progress Reports as set forth in Clause 2.3.6. For the avoidance of doubt, irrespective of the reports to the JRC or the written Progress Reports, the Scientific Program Leads shall exchange information relating to the operational and scientific matters with respect to the Research Activities of the applicable Collaboration Program as reasonably necessary to coordinate and conduct the Research Activities assigned to the Parties under the Research Plan.
3.6 | Alliance Manager |
Each Party shall appoint a person who shall act as the primary point of contact for general matters concerning the Collaboration Programs and this Agreement to assure a successful relationship between the Parties and shall have such other responsibilities as the Parties may agree in the JRC and as documented in the respective JRC minutes after the Effective Date (each, an "Alliance Manager"). The Alliance Managers shall be permitted to attend JRC meetings as appropriate but shall not become voting members of such committee during their role as Alliance Managers. Each Party may replace its Alliance Manager at any time by notice in writing to the other Party.
3.7 | Discontinuation of the JRC |
The JRC shall subsist until, on a Collaboration Program-by-Collaboration Program basis, the earlier of (i) [***], (ii) [***] or the early termination of the Collaboration Program or the discontinuation of the Research Activities, each in accordance with the provisions of this Agreement, or (iii) [***]. Thereafter, each Party shall designate, to the extent necessary, a contact person for the exchange of information under this Agreement or such exchange of information shall be made through the Alliance Managers.
3.8 | Joint Patent Committee |
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3.9 | Expenses |
[***].
3.10 | Future Collaboration |
The Parties shall discuss, no earlier than [***] after the Effective Date, if the Parties are interested in the Development of radioligand compounds directed to further targets outside the scope of the Collaboration Programs.
3.11 | Location of Meetings |
Generally, the regular meetings of the JRC according to Clause 3.2.1 and the JPC according to Clause 3.8.2 shall [***].
4 | Development and Regulatory Matters |
4.1 | Production and Selection of Development Candidate |
4.1.1 | The Parties shall use Commercially Reasonable Efforts to produce a BRC that meets the [***] during the Initial Research Term of the applicable Collaboration Program. |
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required to use Commercially Reasonable Efforts to produce a Non-BRC that meets the [***] in respect of a Bayer Non-RLT Program). |
4.2 | Non-RLT Option |
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on its own outside of a Collaboration Program (the "Bayer Non-RLT Program") ((i) and (ii) collectively referred to as the "Bayer Non-RLT Option"). |
4.2.2 | Bayer may exercise the Bayer Non-RLT Option on a Target-by-Target basis by providing written notice to BicycleTx: |
collectively referred to as the "Non-RLT Option Period".
4.2.6 | On a Target-by-Target basis, any exercise by Bayer of the Bayer Non-RLT Option in respect of a Bayer Non-RLT Program shall not be subject to an option exercise fee. |
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4.3 | Development of Licensed Products |
4.3.1 | For each Target for which Bayer made a Development Candidate Election pursuant to Clause 4.1.5, with respect to such Target, Bayer shall: |
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4.4 | Regulatory Matters |
4.4.1 | Regulatory Activities |
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4.4.2 | Recalls |
Bayer shall notify BicycleTx without undue delay following its determination that any event, incident, or circumstance has occurred that will result in the need for a recall, market suspension, or market withdrawal of a Licensed Product in the Territory and shall include in such notice the reasoning behind such determination. Bayer (or its Affiliate or Sublicensee) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the Territory. If such recall, market suspension, or market withdrawal is mandated by a Regulatory Authority in the Territory and is to be mandatorily implemented without suspensory effect irrespective of any legal remedies or appeals that are pursued by Bayer against the Regulatory Authority's decision, Bayer (or its Affiliate or Sublicensee) shall initiate such recall, market suspension, or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Clause 4.4.24.4.2, Bayer (or its Affiliate or Sublicensee) shall be solely responsible for the execution thereof. Bayer shall inform BicycleTx with regards to the progress of any such recalls, market suspensions or market withdrawals.
4.5 | Records |
Bayer shall maintain records in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, and in compliance with Applicable Law, which shall [***]. Such records shall be retained by Bayer, as the case may be, for at least [***] after the termination or expiry of this Agreement for the respective Licensed Product, or [***].
5 | Commercialisation |
5.1 | In General |
Bayer (itself or through its Affiliates or Sublicensees) shall have the sole right, control and responsibility to Commercialise the Licensed Products in the Territory at its own cost and expense.
5.2 | Commercialisation Diligence |
For each Target for which Bayer made a Development Candidate Election pursuant to Clause 4.1.6, with respect to such Target, Bayer shall use Commercially Reasonable Efforts to Commercialise [***] for therapeutic purposes directed to the applicable Target for humans and in each [***] following receipt of Regulatory Approval thereof in such [***].
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5.3 | Exclusivity |
5.3.2 | [***]. |
5.3.5 | [***]. |
6 | Grant of Rights |
6.1 | Grants to Bayer |
6.1.2 | BicycleTx hereby grants to Bayer a non-exclusive, fully-paid-up, royalty-free, sublicensable only in conjunction with a sublicence under Clause 6.1.1, licence |
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under the BicycleTx Trademarks for use only as an element of a Product Trademark. |
6.2 | Grants to BicycleTx |
Bayer hereby grants to BicycleTx a non-exclusive, fully-paid-up, royalty-free, non-sublicensable (except to its Affiliates or Third Party Service Providers acting on its behalf and approved in accordance with Clause 6.6) licence under the Bayer Background IP, Bayer Sole IP and Bayer Specific Collaboration IP in the Territory and in the Field solely as and to the extent necessary for BicycleTx to carry out its Research Activities as set out in the Research Plan during the Research Term.
6.3 | [***] |
[***].
6.4 | General Knowledge and Public Domain Information |
Nothing in this Agreement will preclude or limit either Party from utilising the non-patented general knowledge gained by it (other than through disclosure to it by the other Party) during the course of the Research Plan to conduct development or commercialisation activities outside the scope of this Agreement.
6.4.1 | For the avoidance of doubt, nothing in this Agreement shall prevent either Party or its Affiliates from using for any purpose any Know-How or other Confidential Information that falls under any of the exceptions for Confidential Information set forth in Clause 9.1. |
6.5 | Sublicences |
6.5.1 | Bayer shall have the right to grant sublicences, through multiple tiers of sublicensees, under the licences granted in Clause 6.1 6.1to its Affiliates and Third Parties, provided that: |
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6.6 | Third Party Service Providers |
Without limiting Clause 6.1 and Clause 6.2, each Party (and their Affiliates) shall have the right to appoint a Third Party [***] to provide research, Development, Manufacturing and Commercialisation services to that Party in connection with the Research Activities assigned to it or such other activities assigned to it with respect to the Licensed Compound or Licensed Products, including contract research organisations, contract manufacturers, academic institutions, service providers and distributors (a "Third Party Service Provider"). Where a Party appoints a Third Party Service Provider during the Research Term of the respective Collaboration Program, such Party shall inform the other Party in writing (for which an email suffices) [***]. For the avoidance of doubt, after the Research Term of a Collaboration Program for which Bayer made a Development Candidate Election, Bayer shall have no obligation to inform BicycleTx of any Third Party Service Providers contracted by or on behalf of Bayer or its Affiliates. Each Party shall enter into a written agreement with each Third Party Service Provider it appoints on terms and conditions that ensure that the subcontracting Party complies with its obligations of this Agreement including its confidentiality obligations and non-use restrictions in Clause 9, the Intellectual Property provisions in Clause 8 and licence grants in this Clause 6 and each Party shall be responsible for the acts and omissions of their Third Party Service Providers.
6.7 | BicycleTx Retention of Rights |
Notwithstanding the exclusive licence granted to Bayer pursuant to Clause 6.1.1, BicycleTx shall retain all rights under the Licensed IP and BicycleTx's share in the Joint Collaboration IP:
6.7.1 | to perform, and to subcontract pursuant to Clause 6.6 its obligations under this Agreement; and |
6.7.2 | for any purpose outside the scope of the licences and rights granted under Clause 6.1, including to develop, manufacture, commercialise and otherwise |
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exploit any products or services other than the Licensed Products, subject to Clause 5.3. |
6.8 | Bayer Retention of Rights |
Subject to Clause 5.3.3 and the licence granted to BicycleTx pursuant to Clause 6.2, Bayer shall retain all rights under Bayer Background IP, Bayer Sole IP, Bayer Specific Collaboration IP and its share in the Joint Collaboration IP.
6.9 | No Implied Licences |
Except as expressly provided herein, BicycleTx grants no other right or licence to Bayer hereunder, including any rights or licences under the Licensed IP and BicycleTx's share in the Joint Collaboration IP or any other Intellectual Property rights not otherwise expressly granted herein. Except as expressly provided herein, Bayer grants no other right or licence to BicycleTx hereunder, including any rights or licences to Bayer Background IP, any Bayer Sole IP, Bayer Specific Collaboration IP and Bayer’s share in the Joint Collaboration IP or any other Intellectual Property rights not otherwise expressly granted herein. Bayer shall not Exploit the Licensed IP and BicycleTx's share in the Joint Collaboration IP or any other Intellectual Property of BicycleTx except as expressly authorised under the terms of this Agreement and BicycleTx shall not Exploit the Bayer Background IP, Bayer Sole IP or Bayer Specific Collaboration IP and Bayer’s share in the Joint Collaboration IP or any other Intellectual Property of Bayer except as expressly authorised under the terms of this Agreement.
7 | Payments, Taxes and Records |
7.1 | Upfront Payment |
In partial consideration of the rights granted to Bayer under this Agreement during the Research Term, within [***] of Bayer's receipt of the relevant invoice from BicycleTx sent on or after the Effective Date, Bayer shall pay BicycleTx a one-time[***] payment in the amount of forty-five million Dollars ($45,000,000) (the "Upfront Fee").
7.2 | Nomination Fee, Substitute Nominated Target Fee and Target Substitute Fee |
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Program within [***] of its receipt of the relevant invoice from BicycleTx sent on or after the agreement of the Research Plan for that Collaboration Program. From, and including the [***] of such Collaboration Program, Bayer shall pay the amount due to BicycleTx within [***] of Bayer's receipt of the corresponding invoice from BicycleTx, but not before the [***] Business Day of such [***]. If Bayer’s payments pursuant to this Clause 7.2.2 have reached in aggregate the maximum amount for the Substitute Nominated Target Fee prior to BicycleTx having completed the Research Activities allocated to it under the applicable Research Plan, BicycleTx shall complete such remaining Research Activities without further payments being due pursuant to this Clause 7.2.2 for the remainder of the Initial Research Term with regard to such Substitute Target as set out in Clause 2.6.1(c). |
7.3 | Bayer Non-RLT Option Fee and Bayer Non-RLT Collaboration Program Fee |
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receipt of the corresponding invoice from BicycleTx, but not before the [***] Business Day of such [***]. |
7.4 | Development Milestones |
7.4.1 | Development Milestone Payments |
In partial consideration of the rights granted by BicycleTx to Bayer hereunder, Bayer shall make a one-time, [***] payment to BicycleTx in the amount corresponding to such Development Milestone Event (each a "Development Milestone Payment") on the first achievement by Bayer, its Affiliates, or their Sublicensees, of each of the milestone events set out in the table below for each Target and for up to two Indications per Target, where applicable (each, a "Development Milestone Event"):
| | Development Milestone Payment | |
---|---|---|---|
| Development Milestone Event (per Target) | [***] Amount | [***] Amount |
1. | [***]4.1.5 | [***] | - |
2. | [***] | [***] | - |
3. | [***] | [***] | - |
4. | [***] | [***] | - |
5. | [***] | [***] | [***] |
6. | [***] | [***] | [***] |
7. | [***] | [***] | [***] |
8. | [***] | [***] | [***] |
7.4.2 | [***]. |
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7.5 | Sales-Based Milestones |
| Sales Milestones Event | Sales Milestone Payment Amount |
---|---|---|
1. | [***] | [***] |
2. | [***] | [***] |
3. | [***] | [***] |
4. | [***] | [***] |
| | TOTAL = £194,494,000 per Target |
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#1 in respect of a Target then Sales Milestone Payment #1 shall be payable at the same time as Sales Milestone #2. |
For the avoidance of doubt, each Sales Milestone may be achieved on a Target-by-Target basis once in respect of a therapeutic Licensed Product and once in respect of a diagnostic Licensed Product. By way of non-exhaustive example, upon the aggregated Net Sales in the Territory of a diagnostic Licensed Product in respect of a Target in a given Calendar Year exceeding [***], Bayer shall pay to BicycleTx [***]. By way of further non-exhaustive example, if Bayer, its Affiliates, or their Sublicensees hits aggregated Net Sales in a Calendar Year in excess of [***] in respect of a therapeutic Licensed Product for the purpose of such Target, Bayer shall also pay to BicycleTx [***].
7.6 | Royalties |
7.6.1 | Royalty Rates |
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Net Sales in the Territory of a Licensed Product in a Calendar Year | Royalty Rate |
---|---|
[***] | [***] |
[***] | [***] |
[***] | [***] |
For the avoidance of doubt, royalties on Net Sales of therapeutic Licensed Products shall be calculated separately from royalties on diagnostic Licensed Products. By way of non-exhaustive example, if the aggregated Net Sales in the Territory of a diagnostic Licensed Product in respect of a Target in a given Calendar Year are [***], Bayer shall pay to BicycleTx a Royalty Rate on those Net Sales of [***], i.e. [***]. By way of further non-exhaustive example, if Bayer, its Affiliates, or their Sublicensees hits aggregated Net Sales in a Calendar Year of [***] in respect of a therapeutic Licensed Product for the purpose of such Target, Bayer shall also pay to BicycleTx a Royalty Rate on those Net Sales of [***] i.e. [***].
7.6.2 | Royalty Term |
The Parties agree that royalties will be payable by Bayer on a Licensed Product-by-Licensed Product and country-by-country basis, commencing on the First Commercial Sale of such Licensed Product in such country and ending on the latest to occur of: (a) the expiration of the last Valid Claim of [***] such Licensed Product in such country; (b) [***] after First Commercial Sale of such Licensed Product for use in humans in such country; or (c) the expiration of Market Exclusivity for such Licensed Product in such country (the "Royalty Term"). For the avoidance of doubt, the expiry of the Royalty Term with respect to a particular country for a given Licensed Product shall not result in the termination of the Royalty Term in any other country or for any other Licensed Product with respect to that country or any other country.
7.6.3 | Royalty Reductions |
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With respect to the rest of the world excluding the United States, on a country-by-country basis, following the first market entry of a Generic Product of a Licensed Product in the applicable country, during the Royalty Term for such Licensed Product in such country, except as set forth in Clause 7.6.4 below, the applicable royalty rate on the Net Sales of such Licensed Product in such country shall be reduced by [***] for such Licensed Product in such country.
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7.6.4 | Royalty Floor |
In no event shall any deduction to Royalty Payments described in one of the subsections in Clause 7.6.37.6.3 (whether alone or in aggregate) reduce the Royalty Payments owed by Bayer to BicycleTx under Clause 7.6.1 by more than [***] in any Calendar Quarter.
7.7 | Royalty Payments and Reports |
Bayer shall calculate all amounts payable to BicycleTx pursuant to Clause 7.6 7.6following the end of each Calendar Quarter. Within [***] after the end of each Calendar Quarter, Bayer shall provide BicycleTx with a statement showing [***].
Bayer shall pay to BicycleTx the royalty amounts due with respect to a given Calendar Quarter within [***] after receipt of a respective invoice.
7.8 | Payment Details |
All payments due to BicycleTx under this Agreement shall be paid upon the receipt of a respective invoice in [***], in accordance with Clause 7.9, except for the Upfront Fee which shall be paid in [***]. All such payments shall be made by wire transfer to the following bank account, or to such other bank account specified in writing by BicycleTx to Bayer at least [***] prior to the due date for payment:
Payment of [***]:
[***]
Payment of [***]:
[***]
Each invoice for payments shall be sent by email only to the below email address and be addressed to:
[***]
mentioning such other information reasonably required and as may be reasonably amended or provided by Bayer to BicycleTx from time to time.
Each invoice for payments mentioning the aforementioned address and reference shall be sent electronically in portable document format (pdf) via email without electronic signature ("pdf-invoicing") to:
[xxxxxxx.xxx.xx.xx@xxxxx.xxx]
thus, replacing a corresponding paper form.
7.9 | Currency Conversion |
All payments under this Agreement will be made in Pounds except the Up-Front Fee which shall be paid in Dollars. Where the payments due under this Agreement are calculated based on a currency other than [***], the amount due will be converted to [***] using the average quarter to date exchange rate for the applicable Calendar Quarter as consistently applied per Bayer’s internal accounting and reporting process
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in accordance with IFRS and being part of the regular review of a certified public auditing company.
7.10 | Taxes |
7.10.1 | VAT |
All sums payable under this Agreement are exclusive of any amount in respect of VAT. If, in respect of any sum payable under this Agreement, the Party receiving the payment (the "Payee") (or a member of its VAT group) is or will be required to account to any tax authority for VAT, the Party making the payment (the "Paying Party") shall, in addition to any other amounts payable under this Agreement, pay to the Payee, against delivery of a valid VAT invoice, an amount equal to such VAT.
7.10.2 | Withholding Tax |
When a Party is required to make a payment to the other Party pursuant to this Agreement, the Paying Party shall be entitled to deduct and withhold from the amount payable any tax which the Paying Party is required by law to withhold or deduct ("Withholding Tax").
BicycleTx herewith confirms as of the Effective Date that any Intellectual Property licensed by BicycleTx to Bayer under this Agreement, in particular the Licensed IP, is not for tax purposes allocated to or held by a permanent establishment of BicycleTx in Germany. BicycleTx will inform Bayer reasonably in advance in case such Intellectual Property is for tax purposes to be allocated to or held by a permanent establishment of BicycleTx in Germany.
If the applicable tax rate for Withholding Tax is actually reduced according to the regulations in an applicable double tax treaty or under local law, no withholding or deduction shall be made or shall be made at a reduced amount, as the case may be, only if the Paying Party is timely furnished with the necessary documents by the Payee. These documents issued by the competent tax authority must certify that the payment is exempt from tax or subject to a reduced tax rate and allow the Paying Party to refrain from making any withholding or deduction or to make the withholding or deduction at a reduced tax rate. The Payee will inform the Paying Party at least [***] before the payment due date if the requirements for an exemption from Withholding Tax or an application of a reduced tax rate for Withholding Tax are no longer satisfied, and not having received such information from the Payee within such time shall be deemed as confirmation by the Payee that such requirements are still satisfied.
Any Withholding Tax deducted by the Paying Party shall be treated as having been paid by the Paying Party to the Payee for all purposes of this Agreement. The Paying Party shall timely forward the receipts certifying the payments of Withholding Tax to the Payee. If and to the extent the Paying Party has not deducted Withholding Tax but is still required by law to pay Withholding Tax to the tax authorities, the Paying Party shall inform the Payee immediately after becoming aware of such obligation and the Payee shall reasonably assist
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the Paying Party with regard to all reasonable procedures required in order to achieve an exemption / release from such payment obligation. In case the Paying Party must pay or is held liable for Withholding Tax and an exemption or release from such payment obligation or liability is not possible after the Parties have made reasonable efforts and cooperated (see Clause 7.10.4), the Payee will pay an amount equal to the amount of Withholding Tax to the Paying Party separately and timely in advance of any payment due date of such Withholding Tax if the Paying Party has given written notice to the Payee of the amount of Withholding Tax that is due at least [***] before any payment due date. If the notification by the Paying Party has not been made at least [***] prior to any payment due date the Payee will pay an amount equal to the amount of Withholding Tax to the Paying Party [***] after the notification by the Paying Party. The Payee shall indemnify and hold the Paying Party harmless from any associated costs if, but only to the extent, they are caused by the Payee's actions (in particular, but not limited to, caused by the Payee's late payment, or the Payee's missing information).
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7.10.3 | Withholding Tax Actions |
Notwithstanding the foregoing, the Parties acknowledge and agree that if Bayer (or its assignee pursuant to Clause 13.313.3) is required by Applicable Law to withhold taxes in respect of any amount payable under this Agreement ("Withholding Obligation"), then if, but only to the extent that: (i) such Withholding Obligation arises as a result of an action of Bayer, including any assignment of this Agreement by Bayer as permitted under Clause 13.313.3, a change in tax residency of Bayer or payments arise or are deemed to arise through a branch of Bayer, and (ii) the amount of such Withholding Tax exceeds the amount of Withholding Tax that would have been applicable if such action of Bayer had not occurred (a "Withholding Tax Action"), then, notwithstanding anything to the contrary herein, any such amount payable by Bayer under this Agreement shall be increased to take into account such Withholding Tax as may be necessary so that, after making all required withholdings, BicycleTx (or its assignee pursuant to Clause 13.313.3) receives an amount equal to the sum it would have received had no such Withholding Tax Action occurred (the "Gross-Up Mechanism"). For the avoidance of doubt, the Parties acknowledge and agree that any Withholding Obligation for Bayer which arises only as a result of any change in any applicable tax law by any competent tax legislator is not to be considered a Withholding Tax Action. However, if the Gross-Up Mechanism applies and BicycleTx has received a credit or refund for the full or partial amount of the applicable payable Withholding Tax, BicycleTx shall pay to Bayer an amount equal to the amount BicycleTx assesses (acting reasonably) which would leave it, after such payment, in the same position as it would have been in the absence of the Withholding Tax and the credit or refund of such payment to be made by BicycleTx within [***] after receiving the tax credit or refund.
7.10.4 | Cooperation |
BicycleTx and Bayer shall use their reasonable efforts and cooperate to avoid any Withholding Tax and failing that to obtain the maximum exemption, credit or refund (as applicable) available in relation to any Withholding Tax in either case to the extent practicable and reasonable under Applicable Law.
7.11 | Interest on Late Payments |
All payments not made by the respective payment date set out in this Agreement, with the exception of payments not paid within [***] of the respective payment date for technical reasons that are outside of the paying party's control, shall be subject to late payment interest thereon [***].
7.12 | Records |
Bayer shall retain, and shall procure that all Sublicensees retain, true and accurate records and books of account containing all data necessary for the calculation of the amounts payable by it to BicycleTx pursuant to the Agreement. Those records and books of account shall be kept for [***] following the end of the period to which they relate.
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7.13 | Audits |
To validate Bayer's, or any of its Affiliates or Sublicensees compliance with its obligations under or in connection with this Agreement, BicycleTx may, during the course of this Agreement and for [***] after expiry or termination of this Agreement, appoint auditors, at BicycleTx's [***] (except as otherwise contemplated below), to carry out an audit of Bayer's records from time to time on behalf of BicycleTx. The auditors selected by BicycleTx shall be subject to acceptance by Bayer, such acceptance not to be unreasonably withheld. Audits may be undertaken subject to the following conditions:
7.13.1 | any such audits shall be undertaken by an independent certified public accountant; |
7.13.3 | the auditor may inspect records for up to [***] after the end of the period to which they pertain; |
7.13.4 | audits may not take place more than [***] per [***] and no period may be audited more than once; |
7.13.7 | the auditor shall not be permitted to include any extrapolation calculations (based on sampling of the underlying data) in the calculation of amounts underpaid to BicycleTx; |
7.13.8 | if an audit reveals that Bayer has underpaid royalties due, BicycleTx may invoice Bayer for the underpaid amount and Bayer shall pay such invoice within [***] of receiving the invoice; |
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8 | Intellectual Property |
8.1 | Ownership of lntellectual Property |
8.1.1 | Ownership of Background IP |
As between the Parties:
8.1.2 | Ownership of Collaboration IP |
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8.2 | Assignment of IP |
8.3 | Patent Prosecution and Maintenance |
8.3.1 | BicycleTx Responsibility |
Subject to Clause 8.3.4(b), BicycleTx shall have the right, but not the obligation, [***], to file, prosecute and maintain worldwide any [***]. With respect to any BicycleTx Bicycle Patents, BicycleTx:
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8.3.2 | Bayer Responsibility |
Subject to Clause 8.3.4(b), Bayer shall have the right, but not the obligation, [***], to prosecute and maintain worldwide any [***]. With respect to the [***], Bayer:
If during the Term, Bayer no longer wishes to file, prosecute or maintain a [***] Bayer shall notify BicycleTx of such intention at least [***] prior to any final deadline with respect to such Patent to enable BicycleTx to decide whether it wishes to obtain ownership of the [***] and, if it does, Bayer shall assign its right, title and interest in and to such [***] to BicycleTx and BicycleTx shall have the right, but not the obligation, to assume responsibility for the prosecution and maintenance thereof at [***] with counsel of its choice.
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8.3.3 | Joint Collaboration Patents |
Any Joint Collaboration Patents shall be filed in the joint names of the Parties and the Parties shall be responsible for sharing the costs (on a fifty/fifty basis) of the filing, prosecution and maintenance of the Joint Collaboration Patents. The Parties shall, through the JPC, cooperate in the filing, prosecution and maintenance of the Joint Collaboration Patents and Bayer, acting through patent counsel of Xxxxx'x choice, shall take the responsibility for implementing the actions decided by the JPC and:
If during the Term, either Party no longer wishes to file, prosecute or maintain a Joint Collaboration Patent, it shall notify the other Party of such intention at least [***] prior to any final deadline with respect to such Patent to enable the other Party to decide whether it wishes to obtain ownership of the first Party's share in the Joint Collaboration Patent and, if it does, the first Party shall assign its right, title and interest in and to such Joint Collaboration Patent to the other Party and the other Party shall have the right, but not the obligation, to assume responsibility for the filing, prosecution and maintenance thereof at [***] with counsel of its choice.
8.3.4 | Cooperation |
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8.4 | Patent Enforcement |
8.4.1 | Collaboration Patents |
8.4.2 | Joint Collaboration Patents |
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8.5 | Cooperation |
8.5.1 | At the request and expense of the Party bringing a claim in respect of a Third Party Infringement action pursuant to Clause 8.4 the other Party shall provide assistance in connection therewith, including by executing reasonably appropriate documents, providing access to the other Party's employees, cooperating reasonably in discovery and joining as a party to the action if |
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required. The Party commencing the litigation shall provide the other Party with copies of all pleadings and other documents filed with the court and shall consider reasonable input from the other Party during the course of the proceedings. Unless otherwise set forth herein, the Party entitled to bring a claim in respect of a Third Party Infringement in accordance with Clause 8.4 shall have the right to settle such claim; provided that neither Party shall have the right to settle any claim in respect of the Third Party Infringement under Clause 8.4 in a manner that diminishes or has an adverse effect on the rights or interest of the other Party, or in a manner that imposes any costs or liability on, or involves any admission by, the other Party, without the express written consent of such other Party. |
8.5.2 | Any recoveries resulting from such an action relating to a claim of Third Party Infringement described in Clause 8.4 shall be [***]. Any [***]; provided, however, that [***]. |
8.6 | Patent Extensions |
8.6.2 | Bayer shall in [***] determine which, if any, [***] it will apply to extend. |
8.7 | Product Trademarks |
As between the Parties, Bayer shall own all right, title, and interest to the Product Trademarks in the Territory, and shall be responsible for the development, selection, registration, prosecution, maintenance and enforcement thereof. [***]. BicycleTx shall [***]. Subject to Clauses 6.1.2 and 6.1.3, Bayer shall ensure that the Product Trademarks do not include any Trademarks that are the same as or confusingly similar to the BicycleTx Trademarks.
8.8 | Inventor's Remuneration |
Each Party shall be solely responsible for any remuneration that may be due such Party's inventors under any applicable inventor remuneration laws.
8.9 | Common Interest |
All information exchanged between the Parties regarding the prosecution, maintenance, enforcement and defence of Patents under this Clause 8 will be deemed to be Confidential Information of the Disclosing Party. In addition, the Parties acknowledge and agree that, [***]. The Parties agree and acknowledge [***]. Notwithstanding anything to the contrary in this Agreement, to the extent a Party has a good faith belief that any information required to be disclosed by such Party to the other Party under this Clause 8 is protected by attorney-client privilege or any other applicable legal privilege or immunity, such Party shall not be required to disclose such information and the Parties shall in good faith cooperate to agree upon a procedure (including entering into a specific common interest agreement or disclosing such
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information on a "for counsel eyes only" basis or similar procedure) under which such information may be disclosed without waiving or breaching such privilege or immunity.
9 | Confidentiality and Non-Disclosure |
9.1 | Confidentiality Obligations |
Each Party (the "Receiving Party") shall, and shall cause its officers, directors, employees and agents to, keep confidential and not publish or otherwise disclose to a Third Party and not use, directly or indirectly, for any purpose, any Confidential Information disclosed to it or otherwise made known to it, directly or indirectly, by the other Party (the "Disclosing Party"), except to the extent such disclosure or use is expressly permitted by the terms of this Agreement or is necessary for the performance of its obligations, or the exercise of such Receiving Party's rights under, this Agreement. Each Party will use at least the same standard of care as it uses to protect its own proprietary or Confidential Information (but no less than reasonable care) to ensure that its employees, agents, consultants, contractors, and other representatives do not disclose or make any unauthorised use of the other Party's Confidential Information. Each Party will promptly notify the other upon discovery of any loss or unauthorised use or disclosure of the other Party's Confidential Information. Notwithstanding the foregoing, to the extent the Receiving Party can demonstrate by documentation or other competent proof, the confidentiality and non-use obligations under this Clause 9.1 with respect to any Confidential Information shall not include any information that:
9.1.4 | is generally made available to Third Parties by the Disclosing Party without restriction on disclosure; or |
9.1.5 | has been independently developed by or for the Receiving Party without reference to, or use or disclosure of, the Disclosing Party's Confidential Information. |
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the Receiving Party merely because the
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Confidential Information is embraced by more general information in the public domain or in the possession of the Receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the Receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the Receiving Party unless the combination and its principles are in the public domain or in the possession of the Receiving Party.
9.2 | Permitted Use or Disclosures |
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9.3 | Use of Name |
Except as expressly provided herein, neither Party shall mention or otherwise use the name, logo, or trademark of the other Party or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity without the prior written approval of such other Party in each instance. The restrictions imposed by this Clause 9.39.3 shall not prohibit either Party from making any disclosure identifying the other Party that is required by Applicable Law.
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9.4 | Press Releases |
The Parties may, on or following the Execution Date, issue a joint press release in the form provided in Schedule 4 to this Agreement. Either Party may desire or be required to issue further press releases concerning this Agreement. The Parties agree to consult with each other reasonably and in good faith with respect to the text and timing of any such press releases prior to the issuance thereof. Notwithstanding the foregoing, neither Party may unreasonably withhold, condition, or delay consent to such releases by more than [***], and either Party may issue such press releases as it determines, based on advice of counsel, is reasonably necessary to comply with Applicable Laws or for appropriate market disclosure. Notwithstanding the previous sentence, neither Party shall disclose the Confidential Information of the other Party in a press release without the other Party's prior written consent (for which an email suffices) or unless otherwise permitted under Clause 9.2 (Permitted Use or Disclosures). Each Party shall provide the other Party with advance notice of legally required disclosures to the extent reasonably practicable, and to the extent possible, at least [***] prior to such disclosure. To the extent that a press release requires the approval of the other Party and to the extent that such approval was obtained, after such approved press release has been issued by a Party, the precise or substantially similar wording may be re-issued by either Party unless (i) the content of such press release becomes misleading, outdated or otherwise inadequate as to subsequent developments; or (ii) the Parties have expressly agreed that a certain press release should exclusively be issued on one or more defined occasions.
9.5 | Publications |
The disclosure by either Party relating to any Licensed Compound or Licensed Product in any publication or presentation shall be in accordance with the procedure set forth in this Clause 9.59.5. A Party ("Publishing Party") shall provide the other Party with a copy of: (i) any proposed publication at least [***] prior to submission for publication, and (ii) any proposed presentation at least [***] prior to the date of that presentation, so as to provide such other Party with an opportunity to recommend any changes to the Publishing Party that it reasonably believes are necessary to continue to maintain that other Party's Confidential Information in accordance with the requirements of this Agreement. The incorporation of such recommended changes shall not be unreasonably refused; and if such other Party notifies ("Publishing Notice") the Publishing Party in writing, within the applicable time period as stated above, that such publication or presentation in its reasonable judgment (a) contains an Invention, solely or jointly owned by the other Party, for which the other Party desires to obtain patent protection, or (b) contains any Confidential Information of the other Party, the Publishing Party shall prevent such publication or delay such publication for a mutually agreed period of time. In the case of Inventions, a delay shall be for a period reasonably sufficient to permit the timely preparation and filing of a patent application(s) on such Invention, and in no event less than [***] from the date of the Publishing Notice. Further, BicycleTx agrees not to make publications without Xxxxx'x prior written consent (not to be unreasonably withheld, conditioned or delayed), by which it would disclose the Know-How which relates exclusively to Licensed Products that it has exclusively licensed to Bayer pursuant to Clause 6.1.1 such that it would undermine Bayer's exclusivity under such licence. After the expiry of the Research Term and for the duration of the licence granted to Bayer under Xxxxxx
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6.1, Bayer shall be permitted, without consulting with and without the consent of BicycleTx, to make publications relating to a Development Candidate or Licensed Product in pursuance of its efforts to Develop and Commercialise Licensed Products, provided that Bayer does not disclose Confidential Information of BicycleTx therein, including any Confidential Information covered by [***].
9.6 | Destruction of Confidential Information |
Upon the effective date of the termination or expiry of this Agreement, on a Target by Target basis, for any reason, the Receiving Party shall, with respect to Confidential Information of the Disclosing Party (in the event of termination or expiry of this Agreement with respect to one (1) terminated Collaboration Program but not in its entirety, solely to the extent relating specifically and exclusively to such terminated Collaboration Programs or Terminated Targets, as applicable) to which the Receiving Party does not retain rights under the surviving provisions of this Agreement, as soon as reasonably practicable, destroy all copies of such Confidential Information in the possession of the Receiving Party and confirm such destruction in writing to the Disclosing Party, provided, that the Receiving Party shall be permitted to retain [***] copy of such Confidential Information for the sole purpose of performing any continuing obligations hereunder, as required by Applicable Law, or for archival purposes. Notwithstanding the foregoing, the Receiving Party also shall be permitted to retain such additional copies of or any computer records or files containing such Confidential Information that have been created solely by the Receiving Party's automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with the Receiving Party's standard archiving and back-up procedures, but not for any other use or purpose. If the termination or expiry of this Agreement is with respect to one or more Terminated Targets or the termination of a Collaboration Program but not in its entirety, to the extent that such Confidential Information cannot be separated from information that relates to Targets and Licensed Products and Licensed Compounds other than the Terminated Targets and terminated Collaboration Programs, the Receiving Party shall have no rights to use or disclose (but will not be required to destroy) such Confidential Information in connection with Terminated Targets or terminated Collaboration Programs following the effective date of termination.
10 | Representations and Warranties |
10.1 | Mutual Representations and Warranties |
BicycleTx and Bayer each represents and warrants to the other, as of the Execution Date as follows:
10.1.1 | Organisation |
It is a corporation duly incorporated, validly existing, and in good standing under the laws of the jurisdiction of its incorporation, and has all requisite corporate power and authority, to execute, deliver, and perform this Agreement.
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10.1.2 | Authorisation |
The execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorised by all necessary corporate action and do not violate (a) such Party's charter documents, bylaws, or other organisational documents, (b) any agreement, instrument, or contractual obligation to which such Party is bound, (c) any requirement of any Applicable Law, or (d) any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect and applicable to such Party.
10.1.3 | Binding Agreement |
This Agreement is a legal, valid, and binding obligation of such Party enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance, and general principles of equity (whether enforceability is considered a proceeding at law or equity).
10.1.4 | No Inconsistent Obligation |
It is not under any obligation, contractual or otherwise, to any Person that conflicts with the terms of this Agreement or that would impede the diligent and complete fulfilment of its obligations hereunder.
10.2 | Additional Representations and Warranties of BicycleTx |
BicycleTx further represents and warrants to Bayer, as of the Execution Date (unless explicitly stated otherwise) as follows:
10.2.1 | BicycleTx has the right to grant the licences to Bayer specified herein; |
10.2.2 | other than the Patents with numbers [***], [***]; |
10.2.3 | to BicycleTx's actual knowledge, there are no judgments against BicycleTx or any of its Affiliates relating to BicycleTx Background IP; |
10.2.5 | to BicycleTx's actual knowledge, no claim or litigation has been brought or threatened in writing by any Person alleging that any BicycleTx Background Patent is invalid or unenforceable; |
10.2.6 | to BicycleTx's actual knowledge, no Person is infringing or threatening to infringe or misappropriating or threatening to misappropriate BicycleTx Background IP; |
10.2.7 | BicycleTx or its Affiliates, as applicable, have obtained [***]; |
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10.2.8 | [***] |
10.2.9 | [***] |
10.2.11 | BicycleTx is resident for tax purposes [***]. |
10.3 | Additional Representations and Warranties of Bayer |
Bayer further represents and warrants to BicycleTx, as of the Execution Date (unless explicitly stated otherwise) as follows:
10.3.1 | other than the Patents with numbers [***], [***]; |
10.3.2 | to Bayer's actual knowledge, there are no judgments against Bayer or any of its Affiliates relating to the Bayer Background IP; |
10.3.4 | to Bayer's actual knowledge, no claim or litigation has been brought or threatened in writing by any Person alleging that any Bayer Background Patent is invalid or unenforceable; |
10.3.5 | to Bayer's actual knowledge, no Person is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Bayer Background IP; |
10.3.6 | Bayer has the right to grant the licences to BicycleTx as specified herein; |
10.3.7 | Bayer or its Affiliates, as applicable, have obtained [***]; |
10.3.8 | [***]; |
10.3.9 | [***]; |
10.3.10 | to Bayer's actual knowledge, neither Bayer nor any of its employees, have ever been, or are currently the subject of a proceeding that could lead to it or |
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10.3.11 | Bayer is resident for tax purposes [***]. |
10.4 | Disclaimer Of Warranties |
Except for the express warranties, representations and covenants set forth herein, neither Party makes any representations or grants any warranties, representations or covenants, express or implied, either in fact or by operation of law, by statute or otherwise, and each Party specifically disclaims any other warranties, representations and covenants, whether written or oral, or express or implied, including any warranty, representations or covenants of quality, merchantability, or fitness for a particular use or purpose or any warranty as to the validity of any Patents or the noninfringement of any Intellectual Property rights of Third Parties. Nothing in this Clause 10.4 limits or excludes any liability for fraud or wilful misconduct.
11 | Indemnification; Insurance |
11.1 | Indemnification of BicycleTx |
Bayer shall indemnify, defend and hold harmless BicycleTx, its Affiliates and [***] (the "BicycleTx Indemnitees") from and against any and all losses, damages, liabilities, penalties, settlements, costs, taxes (including penalties and interest) and expenses (including reasonable attorneys' fees and other expenses of litigation) (collectively, "Losses") in connection with any and all suits, investigations, claims, or demands of Third Parties (collectively, "Third Party Claims") incurred by or rendered against the BicycleTx Indemnitees arising from or occurring as a result of: (a) the breach by Bayer or its Affiliates or Sublicensees of this Agreement; (b) the negligence or wilful misconduct on the part of Bayer or its Affiliates or [***] in performing its or their obligations under this Agreement; or (c) the Exploitation of any Licensed Compounds or Licensed Products by Bayer or its Affiliates or [***]; except, in the case of Clauses (a) through (c) above, to the extent BicycleTx has an obligation to indemnify Bayer pursuant to Clause 11.211.2.
11.2 | Indemnification of Bayer |
BicycleTx shall indemnify, defend and hold harmless Bayer, its Affiliates and [***] (the "Bayer lndemnitees") from and against any and all Losses in connection with any and all Third Party Claims incurred by or rendered against the Bayer Indemnitees arising from or occurring as a result of: (a) the breach by BicycleTx or its Affiliates of this Agreement; or (b) the negligence or wilful misconduct on the part of BicycleTx or its Affiliates or [***] in performing its or their obligations under this Agreement;
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except, in the case of Clauses (a) through (b) above, to the extent Bayer has an obligation to indemnify BicycleTx pursuant to Clause 11.111.1.
11.3 | Notice of Claim |
All indemnification claims in respect of BicycleTx Indemnitees or Bayer Indemnitees shall be made solely by BicycleTx or Bayer respectively (the "Indemnified Party"). The Indemnified Party shall give the indemnifying Party (the "Indemnifying Party") prompt written notice (an "Indemnification Claim Notice") of any Losses or discovery of fact upon which such Indemnified Party intends to base a request for indemnification under this Clause 1111 but in no event shall the Indemnifying Party be liable for any Losses that result from any delay by the Indemnified Party in providing such notice. Each Indemnification Claim Notice must contain a description of the claim and the nature and amount of such Loss (to the extent that the nature and amount of such Loss is known at such time). The Indemnified Party shall furnish promptly to the Indemnifying Party copies of all papers and official documents received in respect of any Losses and Third Party Claims.
11.4 | Control of Defence |
The Indemnifying Party shall have the right, but not the obligation, to conduct and control, through counsel of its choosing, any action for which indemnification is sought, and if the Indemnifying Party elects to assume the defence thereof, the Indemnifying Party shall not be liable to the Indemnified Party for any legal expenses of other legal counsel, or any other expenses subsequently incurred by such Indemnified Party in connection with the defence thereof. The Indemnifying Party may settle any action, claim or suit for which the Indemnified Party is seeking indemnification; provided that the Indemnifying Party shall first give the Indemnified Party advance written notice of any proposed compromise or settlement and such Indemnified Party provides prior written approval, such approval not to be unreasonably withheld, conditioned or delayed. The Parties and their employees shall cooperate fully with each other and their legal representatives in the investigation, defence, prosecution, negotiation, or settlement of any such claim or suit. Each Party's indemnification obligations under this Clause 1111 shall not apply to amounts paid by an Indemnified Party in settlement of any action with respect to a Third Party claim, if such settlement is effected without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld, conditioned or delayed. In no event shall the Indemnifying Party settle or xxxxx any Third Party Claim in a manner that would diminish the rights or interests of the Indemnified Party, admit any liability, fault or guilt by the Indemnified Party or obligate the Indemnified Party to make any payment, take any action, or refrain from taking any action, without the prior written approval of the Indemnified Party.
11.5 | Limitation of Liability |
Except for [***] or required to be paid pursuant to [***] and except in cases of [***], neither Party nor any of its Affiliates shall be liable for indirect, incidental, special, exemplary, punitive or consequential damages including loss of profits or business interruption, however caused, whether in contract, tort, negligence, breach of statutory duty or otherwise in connection with this Agreement or the exercise of any licence granted hereunder, even if advised of the possibility of such damages.
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11.6 | Insurance |
Each Party shall, during the term of this Agreement, at [***], obtain, carry and keep in force liability insurance and other appropriate insurance covering such risks as are appropriate in accordance with sound business practice and the Parties' obligations under this Agreement. In lieu of such insurance coverage, Bayer shall have the right to undertake self-insurance to cover its obligations hereunder, with financial protection comparable to that arranged by it for its own protection with regard to other products in its portfolio. It is understood that no insurance or self-insurance shall be construed to create any limit of either Party's obligations or liabilities with respect to its indemnification obligations under this Agreement.
12 | Term and Termination |
12.1 | Term |
From the Execution Date or the Effective Date, as applicable, the terms of this Agreement shall, subject to Clause 12.1.2, continue in full force and effect, unless earlier terminated in accordance herewith, until the expiration of the Royalty Term for all Licensed Products in the Territory (such period, the "Term"). On the expiration of the Royalty Term 12.1.1 for a particular Licensed Product, on a country-by-country basis, the licences granted to Bayer in Clauses 6.1.1 and 6.1.2 shall become non-exclusive, fully-paid, royalty-free and irrevocable with respect to such Licensed Product in such country.
12.1.2 | This Agreement shall expire, on a Target-by-Target basis, in respect of: |
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12.2 | BicycleTx's Termination Rights |
12.2.2 | BicycleTx shall have the right to terminate this Agreement in its entirety if Bayer or any of its Affiliates or Sublicensees challenges, opposes or otherwise |
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12.3 | Bayer Termination Rights |
12.4 | Termination for Insolvency |
If either Party (a) files for protection under bankruptcy or insolvency laws, (b) makes an assignment for the benefit of creditors, (c) appoints or suffers appointment of a receiver or trustee over substantially all of its property that is not discharged within [***] after such filing, (d) is a party to any dissolution or liquidation (other than for
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the purpose of a solvent amalgamation or reconstruction), (e) files a petition under any bankruptcy or insolvency act or has any such petition filed against it that is not discharged within [***] of the filing thereof, or (f) admits in writing its inability generally to meet its obligations as they fall due in the general course (each a "Insolvency Event"), then the other Party may terminate this Agreement in its entirety immediately on written notice to such Party.
12.5 | Effects of Termination |
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12.5.3 | Upon termination or expiry of this Agreement for any reason in its entirety or partially with respect to, as applicable, any Target, Collaboration Program or Licensed Product: |
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12.5.4 | Upon termination pursuant to Clause 12.2 or 12.3.2, if the termination occurs with respect to a Terminated Asset [***]. |
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13 | Miscellaneous |
13.1 | Force Majeure |
Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement, other than [***], when such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, epidemics, pandemics, quarantines, war, terrorist acts, insurrections, strikes, lockouts, acts of God, or acts or delays in acting by any governmental authority and which it has been unable to overcome by the exercise of its due diligence, provided that the Party unable to perform its obligations shall (i) promptly notify the other Party within [***] of such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimise its effect; (ii) use reasonable efforts to avoid or remove such causes of non-performance; (iii) suspend performance only for such period of time as is necessary as a result of such force majeure event; and (iv) resume performance as quickly as possible.
13.2 | Export Control |
This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries that may be imposed on the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export licence or other governmental approval, without first obtaining the written consent to do so from the appropriate agency or other governmental entity in accordance with Applicable Law.
13.3 | Assignment |
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13.4 | Severability |
If any provision or part provision of this Agreement is held to be or becomes illegal, invalid, or unenforceable under any current applicable law, it is the intention of the Parties that it shall be deemed deleted, but the remainder of this Agreement shall not be affected thereby. If any provision or part-provision of this Agreement is deemed deleted under Clause 13.4, the Parties shall negotiate in good faith to agree a replacement provision that, to the greatest extent possible, achieves the intended result of the original provision.
13.5 | Dispute Resolution |
Any dispute or claim (including non-contractual disputes or claims) arising out of or relating to this Agreement that has not been resolved at the JRC or otherwise under the terms of this Agreement (a "Dispute"), shall be resolved pursuant to this Clause 13.5.
13.5.1 | Referral to Senior Officers |
In the event of a Dispute, the Parties will refer the Dispute to the Alliance Managers for discussion and resolution. If the Alliance Managers are unable to resolve such a Dispute within [***] of the Dispute being referred to them, either Party may refer the Dispute to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resolution of any such Dispute within [***] (or such other period of time as mutually agreed in writing by the Senior Officers) after such Dispute was first referred to them, then either Party shall have the right to refer the Dispute to be settled as set forth in Clause 13.6.2 or Clause 13.6.3 (as applicable).
13.5.2 | Adverse Ruling |
Any determination pursuant to this Clause 13.5 that a Party is in material breach of its material obligations hereunder shall specify a (non-exclusive) set of actions to be taken to cure such material breach, if feasible.
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13.5.3 | Interim Relief |
Notwithstanding anything herein to the contrary in this Clause 13.5, in the event that a Party reasonably requires relief on a more expedited basis than would be possible pursuant to the procedure set forth in this Clause 13, such Party may seek interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute, if necessary to protect the interests of such Party. This Clause 13.5.3 shall be specifically enforceable.
13.5.4 | Pending Dispute, Good Faith Performance of Activities |
During a pending Dispute, where this Agreement has not yet been terminated, each Party shall continue to perform in good faith its obligations under this Agreement.
13.6 | Governing Law, Arbitration and Service |
13.6.1 | Governing Law |
This Agreement and any Dispute shall be governed by and construed in accordance with [***].
13.6.2 | Arbitration |
Subject to Clause 13.5, any Dispute shall be referred to and finally resolved by arbitration under the then-current Rules of Arbitration of the International Chamber of Commerce (the "Rules"), which Rules are deemed to be incorporated by reference into this Clause 13.6.2. The number of arbitrators shall be three. The arbitrators shall be appointed in accordance with the Rules, save that the third arbitrator, who will act as president of the arbitral tribunal, shall not be appointed by the International Court of Arbitration, but by the two arbitrators which have been appointed by either of the Parties in accordance with Article 12 paragraph 4 of the Rules. The legal place of arbitration pursuant to Article 18 paragraph 1 of the Rules shall be [***]. Any meetings and hearings of the arbitral tribunal related to the arbitration pursuant to Article 18 paragraph 2 of the Rules shall be conducted in [***]. The language to be used in the arbitral proceedings (and for all testimony, evidence and written documentation) shall be English. The IBA Rules on the Taking of Evidence in International Arbitration shall apply on any evidence to be taken up in the arbitration.
13.6.3 | Disputes Related to Patent Rights |
Without prejudice to the generality of Clause 13.6.2, if a Dispute arises in respect to the validity, construction, scope, enforceability or infringement, of any Patents, and such Dispute cannot be resolved in accordance with Clause 13.5.1 then, unless otherwise agreed by the Parties in writing, such Dispute shall not be subject to an arbitration proceeding pursuant to Clause13.6.2 and instead either Party may bring an action in any court or administrative agency of competent jurisdiction in which such rights apply, to resolve such Dispute.
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13.6.4 | Service |
Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Clause 13.7.2 shall be effective service of process for any action, suit, or proceeding brought against it under this Agreement in any such court.
13.7 | Notices |
13.7.1 | Notice Requirements |
Unless otherwise agreed by the Parties or specified in this Agreement, all notices, requests and communications between the Parties, and all written documentation to be prepared and provided under, this Agreement shall be in writing in the English language and shall be (a) personally delivered; (b) sent by registered or certified mail; (c) sent by international express courier service providing evidence of receipt (e.g., Federal Express), or (d) by email (with confirmation by registered mail or courier, unless expressly indicated hereunder that written documentation, consent or notification by email suffices) where applicable to the following addresses of the Parties, or such other address for a Party as may be specified in writing pursuant to this Clause 13.7.
13.7.2 | Address for Notice |
[***]
with a copy (which shall not constitute notice) to:
and
[***]
[***]
with a copy (which shall not constitute notice) to:
[***]
13.8 | Entire Agreement; Amendments |
This Agreement, together with the Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises, and representations, whether written or oral, with respect thereto are superseded hereby. Each Party acknowledges that, in agreeing to enter into this Agreement, it has not
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relied on any express or implied representation, warranty, collateral contract or other assurance except those set out in this Agreement. Nothing in this Clause 13.8 limits or excludes any liability for fraud. No amendment, modification, release, or discharge with respect to this Agreement shall be binding upon the Parties unless in writing and duly executed by authorised representatives of both Parties.
13.9 | English Language |
This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control.
13.10 | Waiver and Non-Exclusion of Remedies |
Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein.
13.11 | No Benefit to Third Parties |
Except as provided in Clause 11, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns, and they shall not be construed as conferring any rights on any other Persons.
13.12 | Further Assurance |
Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done all such other acts as may be necessary or appropriate to carry out and give full effect to this Agreement.
13.13 | Relationship of the Parties |
It is expressly agreed that the relationship of the Parties is that of independent contractors, and nothing in this Agreement shall be construed to create a partnership, joint venture, franchise, employment, or agency relationship including for all tax purposes, between the Parties. Neither Party shall be considered the agent of the other Party for any purpose whatsoever and neither Party shall have the authority to enter into any contract or assume any obligation for the other Party or to make any statements, representations or warranty, or commitments of any kind, or to take any action, on behalf of the other Party. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party. The Parties (and any successor, assignee, transferee, or Affiliate of a Party) shall (a) use reasonable efforts to structure the arrangement and activities
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contemplated by this Agreement to avoid the arrangement contemplated by this Agreement being treated as a partnership that is engaged in a "United States trade or business" for United States tax purposes and (b) not treat or report the relationship between the Parties arising under this Agreement as a partnership for United States tax purposes, without the prior written consent of the other Party unless required by a final "determination" as defined in Section 1313 of the United States Internal Revenue Code of 1986, as amended.
13.14 | Performance by Affiliates |
Each Party may use one (1) or more of its Affiliates to perform its obligations and duties hereunder and such Affiliates are expressly granted certain rights herein to perform such obligations and duties; provided that each Party shall procure that each such Affiliate shall be bound by the corresponding obligations of such Party; and provided further that the assigning Party, subject to an assignment to such Affiliate pursuant to Clause 13.3, shall remain liable hereunder for the prompt payment and performance of its obligations hereunder.
13.15 | Non-Solicitation |
Neither Party may, during the Term and for [***] thereafter, directly or indirectly approach or induce with offers of employment, a contract of service or for services or engagement, any of the employees of the other Party that it comes into contact with in performing this Agreement, without first obtaining the prior written approval of the other Party. This Clause 13.15 shall not apply to recruitment achieved through specific local or national placed advertisements where there has been no direct or targeted contact with the individual in question.
13.16 | Counterparts; Electronic Execution |
This Agreement may be executed in one (1) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one (1) and the same instrument. This Agreement including any amendments hereto may be executed by electronically transmitted signatures and such signatures shall be deemed to bind each Party hereto as if they were original signatures.
13.17 | References |
Unless otherwise specified, (a) references in this Agreement to any Clause or Schedule shall mean references to such Clause or Schedule of this Agreement, and (b) references to any agreement, instrument, or other document in this Agreement refer to such agreement, instrument, or other document as originally executed or, if subsequently amended, replaced, or supplemented from time to time, as so amended, replaced, or supplemented and in effect at the relevant time of reference thereto.
13.18 | Order of Precedence |
The Schedules to this Agreement form part of this Agreement. In the event of a conflict or inconsistency between the terms set forth in the body of this Agreement and any schedules or other attachments hereto, the terms of the body of this Agreement shall control.
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13.19 | Construction |
The terms of this Agreement represent the results of negotiations between the Parties and their representatives, each of which has been represented by counsel of its own choosing, and neither of which has acted under duress or compulsion, whether legal, economic, or otherwise. Accordingly, the terms of this Agreement will be interpreted and construed in accordance with their usual and customary meanings, and each Party hereby waives the application in connection with the interpretation and construction of this Agreement of any rule of law to the effect that ambiguous or conflicting terms contained in this Agreement will be interpreted or construed against the Party whose attorney prepared the executed draft or any earlier draft of this Agreement. Except as otherwise explicitly specified to the contrary, (a) the word "including" (in its various forms) means "including without limitation", (b) the words "will" and "shall" have the same meaning, (c) references to a particular statute or regulation include all rules and regulations thereunder and any predecessor or successor statute, rules or regulation, in each case as amended or otherwise modified from time to time, (d) words in the singular or plural form include the plural and singular form, respectively, (e) references to a particular Person include such Person's successors and assigns to the extent not prohibited by this Agreement, (f) the headings contained in this Agreement, in any exhibit, appendix, or schedule to this Agreement are for convenience only and will not in any way affect the construction of or be taken into consideration in interpreting this Agreement, (g) the word "or" means "and/or" unless the context dictates otherwise because the subjects of the conjunction are mutually exclusive, (h) the words "herein", "hereof", and "hereunder" and other words of similar import refer to this Agreement as a whole and not to any particular Clause or other subdivision, (i) all references to days mean calendar days, unless otherwise specified, and (j) all references to 'therapeutic', 'therapeutic use' or 'therapeutic purposes' shall include the treatment or prevention of any disease.
[SIGNATURE PAGE FOLLOWS]
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THIS COLLABORATION AND LICENCE AGREEMENT is executed by the authorised representatives of the Parties as of the Execution Date.
By: | /s/ Xxxxxx Xxxxxxx | |
Name: | Xxxxxx Xxxxxxx | |
Title: | Head of Law, Patents and Compliance Switzerland | |
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