Document:

​

Second Amendment to the
Discovery Collaboration and License Agreement
​
​
between
​
Genentech, Inc.
1 DNA Way, South San Francisco, California 94080, US
(“Genentech”)
​
on the one hand
​
​
​
and

​
​
BicycleTx Limited
B900 Babraham Research Campus, Cambridge, England CB22 3AT
("BicycleTx ")
​

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (I) not material and (II) would be competitively harmful if publicly disclosed.
​

​

​
​
Whereas, Genentech and BicycleTx entered into a certain discovery collaboration and license agreement effective February 21, 2020, as amended (the “Agreement”);
​
Whereas the Agreement was amended by the First Amendment effective 21 February 2020; and
​
Whereas, Genentech and BicycleTx now desire to amend the Agreement in accordance with this second amendment (the “Second Amendment”).
​
Now therefore, in consideration of the mutual covenants and promises contained in this Second Amendment and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound, do hereby agree as follows:
​
		1.	This Second Amendment is effective as of February 21, 2020.

​

		2.	All capitalised terms not defined in this Second Amendment shall have the meanings given to them in the Agreement.	

​
		3.	The following sentences in Section 2.4.1 of the Agreement shall be deleted:

​
“BicycleTx may agree from time to time to transfer materials, including any Bicycle Constructs or Discovery Constructs to Genentech, to enable Genentech to perform certain Discovery Research Activities. BicycleTx’s agreement for any such transfer shall not be unreasonably withheld, conditioned or delayed and shall be performed under the terms of a material transfer agreement (The “MTA”), which MTA shall provide that (a) such materials may only be used in connection with the Discovery Research Activities Genentech has agreed to perform, during the period set forth in such MTA, and (b) no modification or reverse engineering of any materials by or on behalf of Genentech will be permitted, except to the extent expressly set forth in such MTA. The Parties shall negotiate in good faith and agree upon the form of such MTA [ * ].”
​
		4.	The deleted sentences mentioned in Article 3 of this Second Amendment shall be replaced by the following:	

​
“BicycleTx may agree from time to time to transfer materials, including any Bicycle Constructs or Discovery Constructs, to Genentech to enable Genentech to perform certain Discovery Research Activities (collectively, “BicycleTx Materials”). BicycleTx's agreement for any such transfer shall not be unreasonably withheld, conditioned or delayed and, except as outlined in this Agreement, shall be subject to the following conditions:
		-	except as otherwise expressly set forth in this Agreement, all such BicycleTx Materials delivered to Genentech will remain the sole property of BicycleTx;	

		-	Genentech may only use the BicycleTx Materials as specified in the Discovery Research Plan or as outlined in this Agreement;	

		-	Genentech will ensure that the BicycleTx Materials are not used in human subjects or for primary diagnostic purposes;	

		-	Genentech will ensure that the BicycleTx Materials are not used, modified, or delivered to or for the benefit of any Third Party (including any sublicensee) without the prior written consent of BicycleTx (such consent not to be unreasonably withheld, conditioned, or delayed); and	

		-	Genentech will ensure that the BicycleTx Materials are not reverse engineered, and will be used in compliance with Applicable Law.	

​
Genentech will use the BicycleTx Materials supplied under this Agreement with 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (I) not material and (II) would be competitively harmful if publicly disclosed.
​

​

prudence and appropriate caution in any experimental work as not all of their characteristics may be known. BicycleTx will provide Genentech the most current material safety data sheet for the BicycleTx Materials upon transfer of any BicycleTx Materials, if available. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, THE BICYCLETX MATERIALS ARE PROVIDED “AS IS” AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE BICYCLE MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY.
​
BicycleTx will deliver BicycleTx Materials to Genentech [ * ] to a location specified by Genentech [ * ]. Genentech will provide to BicycleTx prior to BicycleTx Material deliveries all the necessary import documentation including but not limited to licenses and other permissions.
​
Genentech shall return to BicycleTx or, at BicycleTx’s discretion, destroy, at the end of the applicable Term, any unused amount of BicycleTx Materials provided by BicycleTx under this Agreement.
​
The transfer of BicycleTx Materials under this Agreement shall be a bailment and shall not constitute a sale of BicycleTx Materials or grant option or license of any patent or other rights owned or controlled by BicycleTx.”
​
		5.	The following sentences in Section 2.4.1 of the Agreement shall be deleted:

​
“In order to facilitate the activities contemplated under the Discovery Research Plan, Genentech may provide to BicycleTx certain Genentech materials, assays or chemical compounds (collectively, “Genentech Materials”). Except as otherwise expressly set forth in this Agreement, all such Genentech Materials delivered to
​

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (I) not material and (II) would be competitively harmful if publicly disclosed.
​

​

BicycleTx will remain the sole property of Genentech, will be used only as specified in the Discovery Research Plan, will not be used, modified, or delivered to or for the benefit of any Third Party (including any sublicensee) without the prior written consent of Genentech (except for subcontractors performing any activities under the Discovery Research Plan), will not be reverse engineered, and will be used in compliance with Applicable Law. BicycleTx will use the Genentech Materials supplied under this Agreement with prudence and appropriate caution in any experimental work as not all of their characteristics may be known. Genentech will provide BicycleTx the most current material safety data sheet for the Genentech Materials upon transfer of any Genentech Materials, if available. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, THE GENENTECH MATERIALS ARE PROVIDED “AS IS” AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE GENENTECH MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY.
​
Genentech will deliver Genentech Materials to BicycleTx [ * ] (to either Block A & B, Portway Building, Granta Park, Great Abingdon, Cambridge, CB21 6GP UK or 4 Hartwell Place, Lexington, MA, 02421-3122 as nominated by BicycleTx) [ * ]. BicycleTx will provide to Genentech prior to Genentech Material deliveries all the necessary import documentation including but not limited to licenses and other permissions.
​
BicycleTx shall return to Genentech or, at Genentech’s discretion, destroy, at the end of the applicable Term, any unused amount of Genentech Materials provided by Genentech under this Agreement.
​
The transfer of Genentech Materials under this Agreement shall be a bailment and shall not constitute a sale of Genentech Materials or grant option or license of any patent or other rights owned or controlled by Genentech.”
​
		6.	The deleted sentences mentioned in Article 5 of this Second Amendment shall be replaced by the following:	

​
“In order to facilitate the activities contemplated under the Discovery Research Plan, Genentech may provide to BicycleTx certain Genentech materials, assays or chemical compounds (collectively, “Genentech Materials”). Genentech’s agreement for any such transfer will not be unreasonably withheld, conditioned or delayed and shall be subject to the following conditions:
​
-except as otherwise expressly set forth in this Agreement, all such Genentech Materials delivered to BicycleTx will remain the sole property of Genentech;
​
-BicycleTx will use the Genentech Materials only as specified in the Discovery Research Plan;
​
-BicycleTx will ensure that the Genentech Materials are not used in human subjects or for primary diagnostic purposes;
​
-BicycleTx will ensure that the Genentech Materials are not used, modified, or delivered to or for the benefit of any Third Party (including any sublicensee) without the prior written consent of Genentech (except for subcontractors performing any activities under the Discovery Research Plan); and
​

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (I) not material and (II) would be competitively harmful if publicly disclosed.
​

​

-BicycleTx will ensure that the Genentech Materials are not reverse engineered, and will be used in compliance with Applicable Law.
​
​
BicycleTx will use the Genentech Materials supplied under this Agreement with prudence and appropriate caution in any experimental work as not all of their characteristics may be known. Genentech will provide BicycleTx the most current material safety data sheet for the Genentech Materials upon transfer of any Genentech Materials, if available. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, THE GENENTECH MATERIALS ARE PROVIDED “AS IS” AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE GENENTECH MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY.
​
Genentech will deliver Genentech Materials to BicycleTx [ * ] to a location specified by BicycleTx [ * ]. BicycleTx will provide to Genentech prior to Genentech Material deliveries all the necessary import documentation including but not limited to licenses and other permissions.
​
BicycleTx shall return to Genentech or, at Genentech’s discretion, destroy, at the end of the applicable Term, any unused amount of Genentech Materials provided by Genentech under this Agreement.
​
The transfer of Genentech Materials under this Agreement shall be a bailment and shall not constitute a sale of Genentech Materials or grant option or license of any patent or other rights owned or controlled by Genentech.”
​
		7.	Section 15.8.1 shall be deleted in its entirety and replaced with the following;

​
15.8.1 Notice Requirements. Any notice, request, demand, waiver, consent, approval, or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if (a) delivered by hand, (b) sent by e-mail to the then current Alliance Manager of the receiving Party and, in the case of BicycleTx, to [ * ] or facsimile transmission (with transmission confirmed), or (c) by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Section 15.8.2 or to such other address as the Party to whom notice is to be given may have provided to the other Party in accordance with this Section 15.8.1. Such notice shall be deemed to have been given as of the date delivered by hand, sent by e-mail or transmitted by facsimile (with transmission confirmed) or on the second Business Day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. This Section 15.8.1 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement.
​

		8.	A new Section 1.24a shall be inserted into the Agreement:

​
1.24a “BicycleTx Materials” has the meaning set forth in Section 2.4.1.
​

		9.	Except as amended herein, all other terms of the Agreement shall remain in full force and effect.	

​
		10.	The Parties agree that in order to fulfill the written form requirement of this Second Amendment, as alternative to handwritten signatures on a hardcopy, electronic	

​

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (I) not material and (II) would be competitively harmful if publicly disclosed.
​

​

signatures (“eSignature[s]”) of duly authorized representatives of the Parties may be used. eSignature shall mean a signature that consists of one or more letters, characters, numbers or other symbols in digital form incorporated in, attached to or associated with the electronic document, that (a) is unique to the person executing the signature; (b) the technology or process used to make the signature is under the sole control of the person making the signature; (c) the technology or process can be used to identify the person using the technology or process; and (d) the electronic signature can be linked with an electronic document in such a way that it can be used to determine whether the electronic document has been changed since the electronic signature was incorporated in, attached to or associated with the electronic document. This Second Amendment may be executed in two counterparts, each of which shall be deemed an original and which together shall constitute one instrument.
​
​
[remainder of page intentionally blank]
​

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (I) not material and (II) would be competitively harmful if publicly disclosed.
​

​

IN WITNESS WHEREOF, the Parties have entered into this Second Amendment as of the last date set forth below.
​
​
​
​
​
BicycleTx Limited
​
    /s/ Michael Skynner
Name: Michael Skynner
Title: Chief Technology Officer Date: 27-Jun-2022
​
​
​
Genentech, Inc.
​
/s/ Beth Odeh-Frikert
Name: Beth Odeh-Frikert
Title: Head Alliance & Asset Management, SSF Date: 25-Jun-2022

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (I) not material and (II) would be competitively harmful if publicly disclosed.
​Exhibit 10.1
​
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
​

FIRST AMENDMENT TO RESEARCH COLLABORATION AND EXCLUSIVE LICENSE AGREEMENT
This First Amendment (the “Amendment”) to that certain Research Collaboration and Exclusive License Agreement entered into as of April 2, 2018 (the “Agreement”) by and between Sigilon Therapeutics, Inc. (“Sigilon”), a Delaware corporation having a place of business at 100 Binney Street, Suite 600, Cambridge, MA 02142, and Eli Lilly and Company, an Indiana corporation having a place of business at Lilly Corporate Center, Indianapolis, Indiana 46285 (“Lilly”), is made effective as of May 5, 2022 (the “Amendment Effective Date”).  Each of Sigilon and Lilly is sometimes referred to individually herein as a “Party” and collectively as the “Parties”.  Capitalized terms used herein, but not otherwise defined, shall have the meanings given to them in the Agreement.
RECITALS
​
WHEREAS, Sigilon and Lilly entered into the Agreement, pursuant to which the Parties have agreed to collaborate in the development of products that are intended for use in the treatment or prevention of diabetes;
​
WHEREAS, the Parties now desire to amend the Agreement to allow for the utilization of Lilly’s expertise in Research Activities for the initial Licensed Product prior to the Research Completion Date; and
WHEREAS, Section 15.6 of the Agreement requires that any amendment of the Agreement be in writing expressly and stated for such purpose.  
NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the Parties hereto, intending to be legally bound, hereby agree as follows:
​
	1.	Lilly Research Plan Activities.  Section 3.6.1 of the Agreement is hereby deleted in its entirety and replaced with this following:

​
“3.6.1Prior to the Research Completion Date. 
​
(a)  Subject to Sections 3.6.1(b) and 3.6.3, if the Disputed Matter occurs prior to the Research Completion Date for the first Licensed Product (including proposed amendments to the Research Plan), and involves Sigilon Research Activities, then the Executive Officer of Sigilon shall have the right to make the final decision on such Disputed Matter, but shall only exercise such right in good faith after full consideration of the positions of both Parties.
​

​

Exhibit 10.1
​
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
​

(b)  Subject to Section 3.6.3, if the Disputed Matter occurs prior to the Research Completion Date for the initial Licensed Product and involves Lilly Research Plan Activities (including identifying and confirming discrete activities to become Lilly Research Plan Activities), then the Executive Officer of Lilly shall have the right to make the final decision on such Disputed Matter, but shall only exercise such right in good faith after full consideration of the positions of both Parties with respect to such Disputed Matter.”
​
	2.	Joint Decisions.  Section 3.6.3 of the Agreement is hereby deleted in its entirety and replaced with this following:

​
“3.6.3Certain Disputed Matters.  If the Disputed Matter involves (a) an amendment to the [****], (b) [****], (c) [****], (d) establishing a new committee or working group, or (e) any matter that is before the JSC that is not subject to either Section 3.6.1 or 3.6.3 (including approving any amendment to the Research Plan, other than with respect to defining Lilly Research Plan Activities), then, in each case of (a) through (e), inclusive, [****] shall have the final decision making authority, and no such proposed amendment shall be adopted unless and until the Parties mutually agree to such amendment; provided, that if the Executive Officers cannot reach agreement within [****] days of such Disputed Matter being referred to them than either Party can refer such Disputed Matter for resolution in accordance with Section 15.1.
​
	3.	Sigilon Responsibilities.  The first sentence of Section 4.1.2(a) of the Agreement is hereby deleted in its entirety and replaced with this following:

​
“Subject to Section 4.1.2(c), Sigilon will be responsible for [****] research activities and the day to day execution and decision making regarding the Research Plan up to IND Filing Readiness (the “Sigilon Research Activities” and the date of completion of all such activities and any Lilly Research Plan Activities, the “Research Completion Date”).”
​
	4.	Lilly Research Plan Activities.  Section 4.1.2(c) of the Agreement is hereby deleted in its entirety and replaced with this following:

​
“Prior to the Research Completion Date, Lilly will have the right, upon written notice to Sigilon, to take over Sigilon Research Activities, in whole or in part; provided, that, if Lilly takes over such activities, then Lilly shall conduct such activities at Lilly’s own cost and expense pursuant to the requirements of Section 4.1.2(b) and Lilly shall have the day to day execution and decision making regarding such activities as Lilly is taking over; provided, further that, if Lilly takes over all Sigilon Research Activities, then Lilly shall conduct such activities [****].  For clarity, Lilly may take over activities under this Section 4.1.2(c) at one time or at different times.  Notwithstanding Lilly taking over such activities, Lilly shall remain responsible for all milestones and royalties with respect to Licensed Products as provided for in this Agreement.  Any such portion(s) so taken over shall be 

​

Exhibit 10.1
​
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
​

deemed to be “Lilly Research Plan Activities” and the Parties shall promptly update the Research Plan in accordance with Section 4.1.1 to reflect the reallocation of responsibilities and submit such update to the JRC for review and approval.” 
​
	5.	Joint Decisions.  The first sentence of Section 4.1.2(d) of the Agreement is hereby deleted in its entirety and replaced with this following:

​
“Following IND Filing Readiness, and provided Lilly has not invoked its rights under Section 4.1.2(c) to take over all of the Sigilon Research Activities, Sigilon shall assemble and prepare the IND filing package (unless Lilly has invoked its right to take over such activities previously), with input from, and in a form consistent with that used by Lilly (“IND Filing Package”) and during such process will make available to Lilly all results, data, and information from the Sigilon Research Activities existing as of such time and that have not been previously provided to Lilly.”
​
	6.	Lilly Responsibilities.  The first sentence of Section 4.1.3(a) of the Agreement is hereby deleted in its entirety and replaced with this following:

​
“Subject to Sections 4.1.2(a), 4.1.2(c) and 5.6, after IND Filing Readiness, Lilly will be responsible for all further Development activities for the initial Licensed Product, including filing of the IND for such initial Licensed Product; and will also be responsible for all research and Development activities with respect to any second or subsequent Licensed Products (collectively, including Lilly Research Plan Activities, the “Lilly Research Activities”).”
​
	7.	Cost of Cell Line Agreements.  Section 7.1.1(d) of the Agreement is hereby amended by adding the following language after the last sentence of 7.1.1(d):

​
“Notwithstanding the foregoing, Lilly shall be responsible for the costs incurred in connection with any Cell Line Agreement upon the assignment of any such contractual arrangements to Lilly.”
​
	8.	Pre-IND Supply.  The first sentence of Section 7.2 of the Agreement is hereby deleted in its entirety and replaced with this following:

​
“Subject to Sections 4.1.2(a) and 4.1.2(c), prior to the Research Completion Date for the first Licensed Product, Sigilon will be responsible for supplying itself with sufficient quantities of Licensed Product (including [****]) for the conduct of the Sigilon Research Activities.”
​
	9.	Full Force and Effect.  Except as expressly stated in this Amendment, the Agreement shall remain unchanged and in full force and effect.  Upon execution, this Amendment shall be made a part of the Agreement and shall be incorporated by reference therein.

​

Exhibit 10.1
​
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
​

​
	10.	General.

​
		a.	Headings.  Section and subsection headings are inserted for convenience of reference only and do not form a part of this Amendment.

		b.	Governing Law.  This Amendment shall be governed by and construed in accordance with the laws of the State of New York (U.S.A.), without regard to the application of principles of conflicts of law.

c.Counterparts.  This Amendment may be executed simultaneously in two or more counterparts, each of which shall be deemed an original and both of which, together, shall constitute a single agreement.  Each Party may execute this Amendment by facsimile transmission or PDF sent by electronic mail.  In addition, facsimile or PDF signatures of authorized signatories of any Party will be deemed to be original signatures and will be valid and binding, and delivery of a facsimile or PDF signature by any Party will constitute due execution and delivery of this Amendment.

​
[SIGNATURE PAGE FOLLOWS]
​

​

Exhibit 10.1
​
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
​

IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed by their duly authorized representatives as of the Amendment Effective Date.
	SIGILON THERAPEUTICS, INC.
	ELI LILLY AND COMPANY

	​
	​

	By:  /s/ Rogerio Vivaldi Coelho​ ​
​
	By:  /s/ Ruth E. Gimeno​ ​
​

	Print Name:  Rogerio Vivaldi Coelho​ ​
​
	Print Name:  Ruth E. Gimeno​ ​
​

	Title:  President, CEO​ ​
​
	Title:  Vice President, Diabetes Research​ ​
​

	Date:  May 5, 2022​ ​
​
	Date:  May 5, 2022​ ​
​

​

​

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00347-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00347-of-00352.parquet"}]]