Acuitas: TECHNOLOGY EVALUATION AGREEMENT For mRNA collaborators
Acuitas is a company developing and commercializing its proprietary lipid nanoparticle (LNP) technology (the “Acuitas LNP”
TECHNOLOGY EVALUATION AGREEMENT
THIS TECHNOLOGY EVALUATION AGREEMENT (“Agreement”) is entered into effective as of [ ] (the “Effective Date”), by and between Acuitas Therapeutics Inc., with offices at 6190 Agronomy Road, Suite 405, Vancouver, British Columbia V6T 1Z3 Canada (“Acuitas”), and [ ], a corporation with offices at [ ], (“Collaborator”). Each a Party and collectively the Parties.
RECITALS
WHEREAS, Acuitas is a company developing and commercializing its proprietary lipid nanoparticle (LNP) technology (the “Acuitas LNP”);
WHEREAS, Collaborator is researching and developing cellular therapeutics and as part of this development employing [mRNA therapeutics] (the “Collaborator mRNA”); and
WHEREAS, Collaborator and Acuitas desire to conduct a feasibility study under this Agreement whereby Collaborator will provide to Acuitas Collaborator mRNA for Acuitas to formulate with the Acuitas LNP. Such Acuitas LNP formulated with Collaborator mRNA the “Formulated Drug”. The Formulated Drug will be used in studies conducted by Acuitas and also delivered to Collaborator for additional studies conducted by Collaborator as described in Schedule 1 (the “Evaluation”).
NOW, THEREFORE, in consideration of the mutual covenants and representations above and hereafter, the Parties agree as follows:
AGREEMENT
1. Evaluation. To avoid any conflicts with current Acuitas Agreements, Collaborator must submit a Protein Target Request Form located in Schedule 2 to the Escrow Agents (Chandra Eidt and Michelle LeCointe at Seed Intellectual Property Law Group LLP) to pre-clear their expected Targets for use in the Evaluation Study. Collaborator understands that this process does not represent a formal reservation of the Targets for Collaborator. Once the Targets are cleared by the Escrow Agents, Collaborator will provide Acuitas with a reasonable quantity of the Collaborator mRNA solely to enable Acuitas to produce the Formulated Drug. Acuitas will then endeavor to formulate the Collaborator mRNA with the Acuitas LNP and, once formulated, Acuitas will undertake the studies described in Schedule 1 and will also deliver the Formulated Drug to Collaborator solely for Collaborator to conduct its studies described in Schedule 1. Without the prior written approval of the other Party and except as specifically contemplated by this Agreement, neither Party will chemically, biologically or otherwise modify any tangible materials furnished by a Party hereunder or reverse engineer, deconstruct or in any way attempt to determine the structure, sequence or composition of any such materials furnished by a Party. Such evaluation (the “Evaluation”) shall consist of the study described in Schedule 1.
2. Evaluation Results. After the Evaluation is completed, each Party will share their respective results of the Evaluation with the other Party (collectively, the “Results”). All such Results are the Confidential Information of both Parties, shall be subject to the confidentiality and non-use provisions of Section 3 and the requirements for publicity and publications of section 7, and shall be used by the Parties solely for the purpose of the Evaluation, and for no other purpose without the prior written consent of both Parties, including for the purposes prohibited by Section 5(b) (New Inventions).
3. Confidentiality. (a). Any information (tangible or intangible and whether in oral, written or electronic form) disclosed by one Party (the “Disclosing Party”) to the other Party (the “Receiving Party”) or developed by a Party in the performance of this Agreement will be treated as confidential information (“Confidential Information”) of the Disclosing Party. The Receiving Party will not disclose any of the Disclosing Party’s Confidential Information to any third party, and will use such Confidential Information solely for purposes of performing the activities under this Agreement. The Receiving Party will return to the Disclosing Party any of the Disclosing Party’s Confidential Information in its possession at the expiration or any earlier termination of this Agreement. All of the Disclosing Party’s Confidential Information shall be and remain the sole and exclusive property of the Disclosing Party. The confidentiality and non-use obligations under this Section 3 will remain in effect during the term of this Agreement and for a period of five (5) years thereafter. Notwithstanding anything to the contrary in this Agreement, (x) the Acuitas LNP will be and remain the sole and exclusive property of Acuitas and is considered the Confidential Information of Acuitas, (y) the Collaborator mRNA will be and remain the sole and exclusive property of Collaborator and is considered the Confidential Information of Collaborator and (z) the Results are the Confidential Information of both Parties. . This Section 3 will survive the expiration or earlier termination of this Agreement. For the avoidance of doubt, the Receiving Party will not use the Disclosing Party’s Confidential Information to support any patent applications, including, without limitation, any patent applications related to the Receiving Party’s Separate IP or any New Invention.
(b) Exceptions . The obligations of confidentiality in this Section 3 shall not extend to any Confidential Information that either Party can demonstrate by written documentation: (w) is or comes into the public domain without breach of this Agreement, (x) is received by a Party from a third party without any obligation of confidentiality and without breach of this Agreement, (y) was already in its possession without any limitation on use or disclosure prior to the Effective Date, or is developed by a Party without use of the Confidential Information as evidenced by the contemporaneous written record.
(c) Disclosures Required by Law . If either Party receives a lawfully issued governmental order or legal requirement to produce or disclose any Confidential Information; it shall promptly notify the other Party to enable that Party to oppose the order or obtain a protective order and the Party shall cooperate fully with the other Party in any such proceeding. If a Party is thereafter still required to disclose Confidential Information, both Parties will endeavour to agree to a mutually satisfactory means to disclose such information.
4. Return of Confidential Information. Any and all Confidential Information in tangible, electronic, or other form received by the Receiving Party will, upon written request of the Disclosing Party, be immediately returned or destroyed, provided however, that each Party will be entitled to retain one copy of all such Confidential Information received from the other Party hereunder for record-keeping purposes, for the sole purpose of ensuring compliance with this Agreement. Notwithstanding the foregoing, the Receiving Party shall not be required to delete or destroy any electronic back-up files that have been created solely by the automatic or routine archiving and back-up procedures of the Receiving Party, to the extent created and retained in a manner consistent with its or their standard archiving and back-up procedures.
5. Separate Intellectual Property; New Inventions. (a) Separate Intellectual Property. It is recognized and understood that any Inventions existing as of the Effective Date, or arising after the Effective Date but separate and apart from the performance of this Agreement (collectively, “Separate IP”) owned or controlled by Acuitas (“Acuitas Separate IP”), or owned or controlled by Collaborator (“Collaborator Separate IP”) are each Party’s respective separate property and, except as otherwise expressly stated herein, are not affected by this Agreement. Except as otherwise expressly stated in this Agreement, neither Party grants to the other Party any right nor license to any of the Acuitas Separate IP or the Collaborator Separate IP, respectively, by virtue of this Agreement. For purposes of this Agreement, the term “Invention” means any technology, discoveries, innovations, improvements and associated intellectual property rights, including all trade secrets, patents, patent applications, invention disclosures, trademarks, trademark applications, trade names, service marks and service names, tangible material (including, without limitation, all biological and chemical materials) and any other form of intellectual property.
(b) New Inventions. Neither Party will file any patent application or otherwise seek to protect any technology, discoveries, innovations, improvements and associated intellectual property rights, including all trade secrets, patents, patent applications, invention disclosures, trademarks, trademark applications, trade names, service marks and service names, tangible material (including, without limitation, all biological and chemical materials) and any other form of intellectual property arising from the Results (“New Invention”).
(c) Survival. This Section 5 will survive the expiration or earlier termination of this Agreement.
6. Patent Rights and Licenses. It is understood that no license or any other right, title or interest in or to any patents, know-how or other intellectual property rights is hereby granted by or to either Party by this Agreement and that the disclosure of Confidential Information to the Receiving Party will not result in any obligation by the Disclosing Party to grant the Receiving Party any rights in and to such Confidential Information.
7. Publicity and Publications. Neither Party will publish the results of the Evaluation without the prior written approval of the other Party. Neither Party will use the name of the other Party or of any of the other Party’s personnel for promotional literature or advertising without the prior written approval of the other Party. The requirements of this Section 7 will be in addition to the obligations of confidentiality set forth in Section 3 hereinabove. This Section 7 will survive the expiration or earlier termination of this Agreement.
8. Additional Use Restrictions. Any materials (including the Collaborator mRNA, the Acuitas LNP, and the Formulated Drug) delivered pursuant to this Agreement (x) are understood to be experimental in nature and may have hazardous properties (and each Receiving Party agrees to handle such materials accordingly), (y) are supplied solely for the studies described in Schedule 1, and (z) are not to be used for in vivo testing in humans or primates.
Acuitas may not provide the Collaborator mRNA or the Formulated Drug to a third party without the prior written approval of Collaborator. Collaborator may not provide the Acuitas LNP or the Formulated Drug to a third party without the prior written approval of Acuitas, provided, however, Collaborator may provide the Acuitas LNP and/or the Formulated Drug to a third party to undertake the Studies on its behalf, if such third party has been identified to Acuitas in advance. Collaborator shall be responsible for ensuring compliance by such third party with the provisions of this Agreement.
9. Costs and Expenses. Each Party will be responsible for its own costs and expenses incurred in carrying out its activities hereunder, unless otherwise mutually agreed in writing. Costs associated with shipping of Formulated Drug by Acuitas to Collaborator will be borne by Collaborator.
10. Mutual Indemnification. Each Party (an “Indemnifying Party”) agrees to be solely responsible for, and to defend, indemnify and hold harmless the other Party and its officers, agents, employees and directors (collectively, the “Indemnitees”) against, any third party claims, including all resulting damages and reasonable attorneys fees (“Claims”), arising from its own negligence, intentional misconduct, breach of this Agreement, or violation of applicable laws. This Section 10 will survive the expiration or earlier termination of this Agreement.
11. Term; Termination. The term of the Agreement will be for a period of one (1) year from the Effective Date of this Agreement, unless extended by written agreement between the Parties or earlier terminated in accordance with this Section 11. Any rights or obligations set forth herein which of their nature are intended to extend beyond the term of this Agreement will survive the expiration or earlier termination of the Agreement. Either Party may terminate this Agreement at any time for any reason or no reason by providing the other Party with 30 days written notice.
12. Assignment. This Agreement will not be assigned by either Party, without the prior express written consent of the other Party provided however that either Party may, without such consent, assign this Agreement and its rights and obligations hereunder to an Affiliate or in connection with the transfer or sale of all or substantially all of its assets related to the subject matter of this Agreement, or in the event of its merger or consolidation or change in control or similar transaction.
13. Severability. In the event that any term of this Agreement is held to be invalid, illegal, or unenforceable, such invalidity, illegality, or unenforceability will not affect any other portion of this Agreement, and the Parties will consult and use good faith efforts to agree as to which term will most fully realize the intent of the Parties as expressed in this Agreement to the fullest extent permitted by applicable law, the Parties hereby declaring their intent that this Agreement be construed in such fashion as to maintain its existence, validity and enforceability to the greatest extent possible.
14. Warranty. Each Party warrants that (i) it is permitted to enter into this Agreement and that (ii) the terms of this Agreement are not inconsistent with other contractual obligations (express or implied) it may have. Each Party hereby acknowledges and agrees that all materials are provided “AS IS.” NEITHER COLLABORATOR NOR ACUITAS MAKE ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THEIR RESPECTIVE MATERIALS OR THE USE THEREOF, OR TO THE LIKELIHOOD OF SUCCESS OF THE EVALUATION. EACH PARTY DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, DURABILITY OR NONINFRINGEMENT. NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY FOR ANY CONSEQUENTIAL OR INDIRECT DAMAGES, REGARDLESS OF THE CAUSE OF ACTION OR THEORY OF LIABILITY OR WHETHER THE PARTY WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING ANYTHING HEREIN, NOTHING IN THIS SECTION 14 SHALL BE DEEMED TO LIMIT ANY OBLIGATION OF A PARTY PURSUANT TO SECTION 10 TO INDEMNIFY THE OTHER AGAINST ANY TYPES OF DAMAGES AWARDED TO A THIRD PARTY CLAIMANT.
15. Governing Law; Jurisdiction. This Agreement will be governed by and construed and enforced in accordance with the laws of the State of New York without reference to any rules of conflicts of laws. This Section 15 will survive the expiration or earlier termination of this Agreement.
16. Amendment; Waiver. None of the terms of this Agreement may be waived or modified except by an express agreement in writing signed by the Party against whom enforcement of such waiver or modification is sought. The failure or delay of either Party in enforcing any of its rights under this Agreement will not be deemed a continuing waiver or a modification by such Party of such right.
17. Entire Agreement. This Agreement sets forth the entire agreement between the Parties with respect to the subject matter hereof and all prior agreements, understanding, promises and representations, whether written or oral, with respect thereto are superseded hereby. The Parties further agree that the recitals set forth on the first page of this Agreement are an integral part hereof, and are therefore considered a part of this Agreement.
18. Counterparts. This Agreement may be executed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument. Facsimile signatures, including signatures transmitted by telecopier or electronically scanned and transmitted signatures in PDF or a similar format, will have the same effect as their originals.
IN WITNESS WHEREOF, the undersigned have by duly authorized persons executed this Agreement hereinbelow.
Acuitas Therapeutics Inc. ___________________
By: By:
Title: Title:
Schedule 1 – Evaluation Study
Schedule 2 – Target Request Form: Protein Target (non-Genome Editing Protein)
Each Target Notice submitted hereunder for a Protein Target that is a Human Protein shall include available information in the following table:
Transcript Identifier: NCBI Refseq transcript ID
Gene Identifier: NCBI Refseq Gene ID
Gene Name and Synonyms1
DNA Sequence coordinates or locus2
Protein Amino Acid Sequence: FASTA format
Notes 1 As determined by the HUGO Gene nomenclature committee.
2 Provide DNA sequence coordinates that encompass the entire protein coding elements of the gene. Provide Chromosome assignment, start, end and NCBI reference version. Where the chromosome for the gene locus is not assigned provide coordinates based on the DNA scaffold identifier or the DNA sequence (contigs) identifier.
Each Target Notice submitted for a Protein Target that is not a Human Protein shall include available information in the following table:
Organism naturally encoding Target (e.g. virus, bacterium)
Protein Name and any Synonyms
Transcript Identifier: NCBI Refseq transcript ID
Gene Identifier: NCBI Refseq Gene ID
Gene Name and Synonyms1
DNA Sequence coordinates or locus2
Protein Amino Acid Sequence: FASTA format
Notes 1 As determined by the HUGO Gene nomenclature committee.
2 Provide DNA sequence coordinates that encompass the entire protein coding elements of the gene. Provide Chromosome assignment, start, end and NCBI reference version. Where the chromosome for the gene locus is not assigned provide coordinates based on the DNA scaffold identifier or the DNA sequence (contigs) identifier.
In cases where the above information is not available, for example for a Protein Target which is not a naturally occurring protein, please provide the following information:
The common name for such Protein Target and any known synonyms, if applicable;
A reference amino acid sequence for the baseline protein (i.e., the protein from which variants are established); and
A description of the biological activity of interest of such Protein Target. Such description to include, for example, the primary biological activity, including enzymatic activity, hormonal or stimulatory activity, protein binding activity, etc. In the case of a Protein Target that is an antibody and binds to a human protein or antigen, the identity of the human protein or antigen should be provided including the information to be provided for a human protein above. In the case of Protein Targets that are antibodies and bind to a non-human protein or a non-human antigen the identity of the non-human protein or non-human antigen should be identified using the above Table where possible.
Target Request Form: Genome Editing Protein Target and associated Human Genome Target
Genome Editing Protein Target(s) to be defined including all available information in the following table:
Organism naturally encoding Target (e.g. human, virus, bacterium)
Protein Name and any Synonyms
Transcript Identifier: NCBI Refseq transcript ID (if available)
Gene Identifier:
NCBI Refseq Gene ID (if available)
Gene Name and Synonyms (if available1
DNA Sequence coordinates or locus2
Protein Amino Acid Sequence:
FASTA format
Notes 1 As determined by the HUGO Gene nomenclature committee.
2 Provide DNA sequence coordinates that encompass the entire protein coding elements of the gene. Provide Chromosome assignment, start, end and NCBI reference version. Where the chromosome for the gene locus is not assigned provide coordinates based on the DNA scaffold identifier or the DNA sequence (contigs) identifier.
Human Genome Target(s) to be defined include all available information in the following table:
Transcript Identifier: NCBI Refseq transcript ID or ENSEMBL transcript ID (include database version)
Gene Identifier:
NCBI Refseq Gene ID or ENSEMBL gene ID (include database version)
Gene Name and Synonyms1
DNA Sequence coordinates or locus2
Gene transcript nucleotide Sequence3
Notes 1 Official gene name as determined by the HUGO Gene nomenclature committee.
2 Provide DNA sequence coordinates that encompass the entire protein coding elements of the gene. Provide Chromosome assignment, start, end and NCBI reference version. Where the chromosome for the gene locus is not assigned provide coordinates based on the DNA scaffold identifier or the DNA sequence (contigs) identifier. DNA regulatory elements that control the transcription of this gene are included by this reservation even if they occur outside of this defined chromosomal region.
3 Encompasses all naturally occurring polymorphic and disease variants.
A Human Genome Target can only contain zero or one gene and cannot contain only a part of a gene.