Form S-4/A Environmental Impact

December 6, 2021 9:20 AM EST

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Exhibit 10.30

Certain identified information has been omitted from this exhibit because it is not material and of the type that the registrant treats as private or confidential. [***] indicates that information has been omitted.

LICENSE AND SPONSORED

RESEARCH AGREEMENT

THIS LICENSE AND SPONSORED RESEARCH AGREEMENT (this “Agreement”), effective as of April ___, 2010 is made and entered into by and between YISSUM RESEARCH DEVELOPMENT COMPANY OF THE HEBREW UNIVERSITY OF JERUSALEM LTD., of Hi Tech Park, Edmond J Safra Campus, Givat Ram, Jerusalem 91390, Israel (“Yissum”), and BEEOLOGICS, INC., a corporation organized and existing under the laws of the British Virgin Islands, having its principal place of business at 11800 SW 77 Ave, Miami, Fl. 3315, U.S (the “Company”). (Yissum and the Company may be sometimes referred to herein individually as, a “Party” and collectively as, the “Parties.”)

R E C I T A L S

A. The rights and title to all inventions and research results of scientists of the University (as defined below) vest solely with Yissum.

B. The Company has represented to Yissum that the Company has the knowledge and experience necessary to conduct research and develop products based on the inventions and research that are the subject of this Agreement; and that, either by itself or through third Parties, it has or will have the financial capacity and the strategic commitment to facilitate the research, development, production, marketing and distribution of products.

C. Yissum wishes to collaborate with the Company for research, development and commercial exploitation of certain inventions and research; and for that purpose has requested the Company to participate m the research and development activities pertaining to same.

D In order to implement said collaboration the Parties executed a memorandum of understanding on February 17, 2008 (the “MOU”), with this Agreement substituting and repealing such MOU for all intents and purposes.

E. The Parties agree to continue said collaboration upon the terms and conditions set forth herein.

NOW THEREFORE, in consideration of the foregoing and the obligations, undertakings and promises contained herein, and for good and valuable consideration the sufficiency of which is hereby acknowledged, the Parties agree as follows.


A G R E E M E N T

 

  1.

DEFINITIONS

1.1 As used herein, the following terms shall have the following meaning:

(a) ”Assigned Technology” has the meaning given to it in Section 4,2 hereof.

(b) ”Affiliate” means any person, organization or other legal entity which controls, or is controlled by, or is under common control with, the Company or Yissum, as applicable. “Control” shall mean the holding of more than fifty percent (50%) or more of (i) the voting rights of a given entity, and (ii) the right to elect or appoint directors of such entity.

(c) ”Combination Product” has the meaning given to it in Section 7 1(a) hereof.

(d) ”Committee” has the meaning given to it in Section 5 2 hereof.

(e) ”Company” has the meaning given to it in the preamble hereof.

(f) ”Company Cessation Event” has the meaning given to it in Section 14.2 hereof.

(g) ”Company Shareholders Option” has the meaning given to it in Section 14 2 hereof.

(h) ”Development Plan” has the meaning given to it in Section 5.1 hereof,

(i) ”Development Reports” has the meaning given to it in Section 5.2 hereof.

(j) ”Development Results” has the meaning given to it in Section 3 3 hereof.

(k) ”Expense Deposit” has the meaning given to it in Section 9.2 hereof.

(l) ”HAY Technology” [***].

(m) ”IP” means any and all intellectual property rights, including, but not limited to, any and all, Patents, copyrights, trademarks, trade names, service marks, design marks, trade secrets and other proprietary rights of any kind or nature, all whether or not pending, perfected, registered, registrable or patentable, and including, further, any and all rights, interests or titles in and to any Know-How;Company IP” means any and all IP owned by the Company, including, but not limited to, the Company’s relative ownership in the Joint IP, and will include IP licensed, obtained or received from third parties. The Company IP as of the date hereof is depicted on Appendix Al hereof; “Yissum IP” means the IP owned by Yissum, including, but not limited to, Yissum’s relative ownership in the Joint IP. Yissum IP as of the date hereof is described in Appendix A2 hereof; and “Joint IP” means any and all IP jointly owned by the Company and Yissum with respect to the Licensed Technology, including any and all IP deriving from Research Results in accordance with Section 3.2 hereof. The Joint IP as of the date hereof, is depicted on Appendix A3 hereof.

 

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(n) ”Joint Patents” means such Patents that are included in the Joint IP.

(o) ”Know-How” means any information, ancillary materials, processes, results, devices and/or know-how developed and owned by either or both Parties, (as applicable), whether patentable or not, provided that the said information is not public knowledge or in the public domain Notwithstanding the aforesaid, the Know-How shall not be regarded as public domain or public knowledge if, the particulars, the application or utilization of a general principal or a certain idea (that are regarded as public knowledge), are not themselves public knowledge or in the public domain.

(p) ”Indemnitees” has the meaning given to it in Section 13.3 hereof.

(q) ”License” has the meaning given to it in Section 4.1 hereof.

(r) ”License Maintenance Fee” has the meaning given to it in Section 7 1 hereof.

(s) ”Licensed Technology” has the meaning given to it is Section 4.1 hereof.

(t) ”MOU” has the meaning given to it in the preamble hereof.

(u) ”Net Sales” means (x) the gross sales price invoiced for sales, leases or other transfers of Products by the Company, an Affiliate or Sublicensee to a third Party who will be an end user of the Products, or (y) the market value of non-monetary consideration actually received in connection with such sales, leases or transfers; after deduction of (i) all commercially reasonable discounts, rebates and return credits, provided that such deductions shall be directly related to the sale of Products that were awarded within the regular running of the business of the Company, Affiliate or Sublicensee; and (ii) VAT; and (iii) Third Parties Royalties, actually paid in connection with the applicable Products as appearing on the books of the Company, the Affiliate or the Sublicensee, as applicable, provided that the Company shall disclose all the details of the requirement to pay such Third Party Royalties, including, but not limited to, any written agreements pursuant to which the payment of such Third Party Royalties is required. In the event of sales made through a distributor or marketing agent, the sales made by such distributors or marketing agent shall be deemed gross sales of the Company for the purposes of this Agreement and amounts paid by the Company to such distributor or marketing agent as commissions or marketing fees for such sales shall be deducted from such gross sales, provided that such deductions shall not exceed fifteen percent (15%) of the gross sales price of the Products, unless the Company can demonstrate through a written agreement negotiated at arms-length and disclosed to Yissum that a greater percentage is required. In the event of sales or deductions not made at “arms length”, then for the purpose of calculation of Royalties to Yissum, Net Sales shall be calculated in accordance with arms length prices for sale of Products to end users and arm’s length deductions, to be determined by the current market conditions, of in the absence of such conditions, according to the assessment of an independent appraiser to be selected by the Parties,

 

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the costs of whom to be paid by the Party whose claim was rejected by the independent appraiser. For the sake of clarity, sales to end users for the purpose of the conduct of clinical trials required for the regulatory approval of a Product shall not be considered sales pursuant to this Section 1, provided that the Company, the Affiliate or Sublicensee shall provide Yissum, within reasonable time after its written request, with documentation demonstrating the nature of such sale upon request.

(v) ”OCS” means the Office of the Chief Scientist of the Israeli Ministry of Industry and Trade.

(w) ”Ongoing Patent Costs” has the meaning given to it in Section 9.1 hereof.

(x) ”Party” has the meaning given to it in the preamble hereof.

(y) ”Pass-Through Right” has the meaning given to it m Section 14 2 hereof.

(z) ”Patent” means all patent applications or registered patents, any patent application that claims priority therefrom; all divisions, continuations, continuations-in-part, re-examinations, reissues, substitutions, or extensions, including European Supplementary Protection Certificates (SPCs), and any and all patents issuing from, and inventions, methods, processes, and other patentable subject matter disclosed or claimed m same.

(aa) ”Product” means any product that is either (x) [***]; or (y) [***], and any product or composition comprising said inserts, but excluding products designated to control other pests.

(bb) ”Representatives” has the meaning given to it in Section 5.2 hereof.

(cc) ”Research” means the sponsored research to be conducted by or under the supervision of the Researcher in connection with controlling the varroa mite by silencing varroa genes via RNAi constructs provided to the bees and transferred to the varroa. For the sake of clarity, any research, development or other activity relating to horizontal transfer of RNAi molecules other than transfer from bees to varroa is expressly excluded from the scope of this Agreement, and each party will be free to perform any such activity as it deems fit separately without any accountability to the other party.

(dd) ”Research Debt” has the meaning given to it in Section 2.5 hereof.

(ee) ”Research Fee” has the meaning given to it in Section 2,4 hereof. “Researcher” means Prof. Ilan Sela, or such other person as determined and appointed from time to time by Yissum in accordance with Section 2.2 hereof, to supervise and to perform the Research, if applicable.

(ff) ”Research Period” has the meaning given to it in Section 2.3 hereof.

 

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(gg) ”Research Program” means the program as shall be approved by the Company from tune to time under which the Research shall be carried out and conducted by or under the supervision of the Researcher and/or any Company Researchers. The current Research Program is annexed hereto as Appendix B.

(hh) ”Research Report” has the meaning given to it in Section 2.5 hereof.

(ii) ”Research Results” means the results of the Research m accordance with the Research Program, including any Patents and Know-How directly resulting therefrom. For the avoidance of doubt, the HAV Technology is not part of the Research Results.

(jj) ”Royalties” has the meaning given to it in Section 7.1 hereof.

(kk) ”Sublicense” means any grant by the Company or its Affiliates to third parties of the right to develop the Licensed Technology, which right may include the rights to manufacture, market and distribute the Products.

(ll) ”Sublicense Considerations” means any proceeds or consideration or benefit of any kind whatsoever, other than royalties on Net Sales, which the Company or an Affiliate may receive from a Sublicensee as a direct or indirect consideration of the grant of a Sublicense or an option to obtain such Sublicense.

(mm) ”Sublicense Fees” has the meaning given to it in Section 7 1 hereof.

(nn) ”Sublicensee” means any third party to whom the Company or an Affiliate shall grant a Sublicense or option to obtain such Sublicense. For the sake of clarity, Sublicensee shall include any other third party to whom such rights shall be transferred, assigned, or who may assume control thereof by operation of law or otherwise.

(oo) ”Territory” means worldwide.

(pp) ”Third Parties Royalties” means royalties calculated on any amount invoiced by the Company or an Affiliate thereof in connection with the sale of a Product and actually paid by the Company to any third party for the right to use Patents or other IP, without which right of use the Company would not be entitled to perform research, develop, manufacture or sell such Product, provided that the duty to pay such royalty to such third party has been established in good faith, arises under applicable law or statute or is set out m a written agreement.

(qq) ”University” means the Hebrew University of Jerusalem and each of its branches.

(rr) ”VAT” means value added taxes, sales taxes or any other similar taxes, all at the rate prescribed by the applicable laws.

(ss) ”Yissum” has the meaning given to it in the preamble hereof.

 

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(tt) ”Yissum Auditors” has the meaning given to it in Section 8.7 hereof.

1.2 Unless the context otherwise requires, as used in this Agreement, the singular number includes the plural and the plural number may include the singular. The use of any gender shall be applicable to all genders. The terms “hereof’, “herein”, “hereunder”, “hereby” and “hereto” as well as words of similar import when used in this Agreement shall refer to this Agreement as a whole and not to any particular provision, unless otherwise is expressly specified.

 

  2.

SPONSORED RESEARCH

2.1 The Company hereby undertakes to finance performance of the Research in accordance with the Research Program or any mutually agreed upon amendment thereof.

2.2 The Research shall be conducted by and under the supervision of the Researcher and the Company Researchers. Should the Researcher be unable to complete the Research for any reason or if the Researcher does not meet his obligations and undertakings hereunder m a complete and timely manner, the Company shall have the right to terminate Research and perform it by itself, provided that (a) no monies paid to Yissum on account of the Research Fee will be refundable, and (b) the Company shall be responsible for the payment of any accrued fees and expenses due to Yissum based on work duly performed up to the date of termination and those irrevocable commitments entered into by Yissum in accordance with the Research Program prior to having received the Company’s written notice of termination.

2.3 The Research shall be conducted during the period set forth in the Research Program (the “Research Period”). Any further Research shall be conducted in accordance with future agreements between the Company and Yissum.

2.4 As sole and full compensation to Yissum for the Research and subject to any earlier termination of the Research pursuant to Section 2,2 hereof, the Company shall pay Yissum the amount set forth in the Research Program (the “Research Fee”) plus VAT, if any (inclusive of Yissum or University overhead), for each Research Period, to be paid monthly in advance until the Company has closed its next round of investment in an amount of not less than [***], The Company agrees that any late payment of the Research Fee pursuant to this Section 2.4, shall bear interest at an annual rate of ten percent (10%).

2.5 [***].

2.6 For the avoidance of doubt, nothing herein shall prevent Yissum or the University or the Researcher from obtaining further finance or grants from other entities for research regarding the Licensed Technology, provided that such entities shall not be granted rights in the Research or Research Results prejudicial to the rights granted to the Company in this Agreement.

2.7 [***].

 

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2.8 Nothing contained in this Agreement shall be construed as a warranty on the part of Yissum that any results or inventions will be achieved by the Research, or that the Research Results, if any, are or will be commercially exploitable Yissum makes no warranties whatsoever as to the commercial or scientific value of the Research Results. Notwithstanding the foregoing, the Researcher shall ensure that the reports required by Section 2.7 hereof, contain complete results of the Research.

2.9 The following provisions will apply in Company choose to retain the services of the Researcher or any other employee of the University, as a consultant in connection with the Research:

(a) Should the Company choose to (i) retain the services of the Researcher or any other employee of the University as a consultant in connection with the Research, or (ii) grant any benefit, including but not limited to, cash payments or securities of any kind, to the Researcher or any other employee of the University in connection with the Research, it shall do so only through a written agreement executed between the Company and Yissum.

(b) [***].

(c) [***].

(d) [***].

 

  3.

INTELLECTUAL PROPERTY RIGHTS

3.1 Other than as expressly set forth herein and subject to any assignment or transfer of any IP made in accordance herewith or pursuant hereto, Yissum retains full and sole title to Yissum IP and the Company retains full and sole title to the Company IP. Any IP of either Party which does not pertain to the Licensed Technology or the Assigned Technology is expressly excluded from the scope of this Agreement.

3.2 Any IP deriving from the Research Results will be jointly owned by the Parties and will become, from inception, part of the Joint IP, in the proportions to be mutually agreed upon by the Parties and the absence of such agreement, to be determined by the arbitrator referred to Section 16 hereof, which IP to be added to Appendix A3. For the sake of clarity, Yissum’s rights in any Joint IP thus created shall be deemed and considered from inception as part of the Licensed Technology and the terms and conditions of this Agreement shall govern the use thereof by the Company.

3.3 Any results of activities carried out by the Company or by third Parties (including, but not limited to, any “work made for hire”) at the direction of the Company (other than Research conducted by the Researcher, or under his supervision) pursuant to the Development Plan, including any Patents and Know-How resulting therefrom, including any regulatory filing filed, or approval obtained, by the Company, an Affiliate or Sublicensee in respect of the Products (“Development Results”) will he with the Company and will become and be deemed from inception an integral part of the Company IP.

 

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3.4 It is hereby specifically agreed that Yissum shall not transfer its interest in any Joint IP to any third party without the advanced written consent of the Company.

 

  4.

LICENSES; ASSIGNMENT

4.1 Yissum hereby grants the Company an exclusive license to make commercial use of Yissum IP (the “Licensed Technology”), m order to develop, manufacture, market, distribute or sell a Product, all within the Territory only and subject to and in accordance with the terms and conditions of this Agreement (the “License”).

4.2 [***].

4.3 The provisions of Section 4.1 hereof notwithstanding, Yissum, on behalf of the University, shall retain the right, provided, always, that the exercise of such right shall not result in competition to the Company, the Licensed Technology, the Assigned Technology or the Products, (a) to make, use and practice the Licensed Technology for the University’s own internal research and educational purposes; (b) to license or otherwise convey to other academic and not-for-profit research organizations for no charge other than shipping fees the Licensed Technology for use in non-commercial research; all provided, always, that such license does not directly or indirectly harm the Company’s commercial interests in the Company IP, the Licensed Technology or the Assigned Technology, and provided further that any transfer of materials shall not be made without first giving notice to the Company. Said right of Yissum is further conditional upon, and subject to, Yissum ensuring that each recipient of Licensed Technology hereunder has properly executed an undertaking (or is otherwise bound by law) to maintain confidentiality in such degree that will not fall below that which is contemplated in Section 11 hereof and that it has given a written notice to the Company of its intention to exercise such right at least thirty (30) days in advance.

4.4 The License shall end, on a country-by-country basis, upon the later of, (x) the date of expiration of the last valid Patent included in the Licensed Technology; (y) the end of any exclusivity on the Product granted by a regulatory or government body, or (z) the end of a period of twenty (20) years from the date of the First Commercial Sale Should the periods referred to in paragraphs (i) or (ii) expire prior to twenty (20) years from the date of the First Commercial Sale in a particular country or countries, the license in that country or those countries shall be deemed a license to the Know-How.

4.5 Otherwise than as set forth in Section 4 5 hereof, the License may terminate only upon termination of this Agreement.

 

  5.

DEVELOPMENT AND COMMERCIALIZATION

5.1 The Company undertakes, at its own expense, to use its best efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with a written plan and timetable for the development and the commercialization of Products or subsequent results of any commercial development (the “Development Plan”), a copy of which is annexed to this Agreement as Appendix C. The Development Plan may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth above, upon Yissum’s approval, which shall not be unreasonably withheld, conditioned or delayed. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results.

 

 

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5.2 The Parties shall establish a steering committee (the “Committee”) to oversee the exercise of the License. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Representatives”), who shall meet at least twice per calendar year unless the Parties agree otherwise, The Representatives shall be bound by the confidentiality arrangements set out in this Agreement, The Company shall consult with Yissum, via Yissum’s Representatives, in respect of significant decisions related to the exercise of the License. For the avoidance of doubt, the Committee shall be a forum for the exchange of information between the Parties with respect to the foregoing matters, shall act only in an advisory capacity and shall not have decision-making powers. It is agreed that any and all expenses incurred in by Yissum’s Representatives as a result of their participation in the Committee shall be borne and paid by the Company. The Parties further agree that the Company shall be entitled to convene Committee meetings by telephone or video conference. Notwithstanding anything to the contrary, including any reports regarding the Research, the Company shall (a) provide Yissum via Yissum’s Representatives with periodic written reports in the OCS format (“Development Reports”) not less than once per every twelve (12) months concerning all material activities undertaken in respect of the exercise of the License, (b) keep Yissum informed via Yissum’s Representatives substantially on a timely basis concerning all material activities and changes to the Development Plan undertaken in respect of the exercise of the License, and (c) at Yissum’s request, from time to time, provide Yissum with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include a summary of the Development Results and any other elated work effected by the Company or by any Affiliate or Sub-Licensee during the six (6) month period prior to the report. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected — or actual — completion date of the development of a Product and the marketing thereof; sales forecasts, if any have been made in the regular course of the Company’s business; a description of any corporate transaction involving the Products or the Licensed Technology, and shall detail all proposed changes to the Development Plan, including the reasons therefor.

5.3 Upon completion of the development of any Product as defined in Section 1.1(aa)(y), the Company undertakes to perform commercially reasonable actions necessary to maximize Net Sales of such Product on a regular and consistent basis.

5.4 If the Company shall not commercialize the Products, as defined m Section 1 1(aa)(y), within a reasonable time frame, unless such delay is caused by (a) the requirements of a regulatory authority; (b) force majeure; (c) lack of commercial viability caused by factors external to the Company, provided that the Company shall make commercially reasonable efforts to remove such factors; or (d) unless the Company and Yissum have agreed in writing to amend the Development Plan, Yissum shall notify the Company in writing of the Company’s failure to meet its obligations of diligence and shall allow the Company ninety (90) days to cure its failure of diligence. The Company’s failure to clue within such ninety (90) day period to Yissum’s reasonable satisfaction shall give Yissum the right to terminate this Agreement as its sole remedy in such event.

 

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  6.

SUBLICENSES

6.1 The Company shall be entitled to grant a Sublicense only after obtaining Yissum’s written approval regarding the identity of the Sublicensee and all material terms and conditions of the Sublicense, which approval shall not be unreasonably withheld, conditioned or delayed, Failure by Yissum to respond within thirty (30) days of receiving the Company’s request to that effect, will be deemed approval for purposes hereof. For the avoidance of doubt, an agreement with either (x) a subcontractor or IP collaborator in which the Company must grant the subcontractor or collaborator the right to make use of the Licensed Technology or Assigned Technology on behalf of the Company, and for which use the Company is required to pay or otherwise compensate the subcontractor; or (y) a distributor, reseller or sales agent that is responsible for selling finished Products to end users shall not be considered a Sublicense for purposes of this section 6.1.

6.2 Upon submission of its request to obtain the written consent of Yissum to a Sublicense, the Company shall fully disclose and submit to Yissum all relevant material documentation relating to the Sublicense, adequately disclose to Yissum any other business connection which it now has or is in the process of forming with the Sublicensee which may reasonably effect the decision of the Company regarding terms and conditions of the Sublicense; and shall notify Yissum in writing, whether a proposed Sublicensee is an Affiliate or is otherwise related to the Company In addition, the Company shall provide Yissum with an executed copy of the Sublicense within ten (10) working days of its execution.

6.3 If the Company is unable or unwilling to serve or develop a potential market or market territory for which there is another third party willing to be a sublicensee, the Company will, at Yissum’s request, negotiate in good faith a sublicense with such third party, unless such third party is a competitor of the Company or its Affiliates or, otherwise, contracting with such third party is reasonably likely to be detrimental to the Company’s or its Affiliates’ business.

6.4 Any Sublicense shall be dependent on the validity of the License and shall terminate upon termination of the License.

6.5 The Company shall ensure that any Sublicense shall include material terms that bind the Sublicensee to observe the terms of this Agreement, including, but not limited to, Section 13 hereof, the breach of which terms shall be a material breach resulting in the prompt termination of the Sublicense In such an event, the Company undertakes to take all reasonable steps to enforce such terms upon the Sublicensee, including the termination of the Sublicense. In all cases, the Company shall immediately notify Yissum of any breach of the material terms of a Sublicense, shortly after it becomes aware of any such circumstance and shall copy Yissum on all material and relevant correspondence with regard such breach.

6.6 The Company shall require any Sublicensee to provide it with royalty reports that include at least the detail that the Company is required to produce pursuant to Section 8 2 hereof Upon request, the Company shall produce such reports to Yissum.

6.7 Any breach of a Sublicense Agreement by a Sublicensee which would have constituted a breach of this Agreement by the Company had it been an act or omission of the Company, and which the Company has not terminated the Sublicense m the absence of the Sublicensee curing such breach, shall constitute a breach of this Agreement by the Company.

 

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6.8 Under no circumstance whatsoever shall a Sublicensee be entitled to grant the Sublicense or any part thereof to any third party.

 

  7.

CONSIDERATIONS

7.1 In consideration for the grant of the License, and in addition to the Research Fee, the Company shall pay Yissum the following considerations during the term of the License.

(a) Royalties at a rate [***] of the Net Sales of Products, as defined in Section 1 1(aa)(y) hereof, and Royalties at a rate [***] of Net Sales of Products as defined in Section 1.1(aa)(x) hereof, (as applicable, the “Royalties”). Notwithstanding anything to the contrary set forth herein, in the event a Product is sold by the Company, an Affiliate or a Sublicensee in the form of a combination product, that is, a product which is based on IP other than Yissum IP, Joint Patents or the HAV Technology, (a “Combination Product”), Net Sales from such Combination Product, for purposes of determining royalty payments, [***], In such event, the parties shall negotiate in good faith to arrive at a determination of the respective fair market values of the Product and all other ingredients included in the Combination Product.

(b) Commencing seven (7) years from the date the MOU was signed, and each year thereafter, the Company shall pay Yissum an annual maintenance fee [***] for maintaining the License (the “License Maintenance Fee”) The License Maintenance Fee is non-refundable and shall be credited each year against Royalties payable on account of Net Sales and Sublicense Fees made during that year.

(c) Sublicense fees at a rate of [***] of Sublicense Consideration (“Sublicense Fees”). For the sake of clarity, under no circumstances may sales and marketing agents, distributors or resellers of the Products or similar functionaries be deemed or considered as Sublicensees.

7.2 [Omitted].

 

  8.

REPORTS AND ACCOUNTING

8.1 The Company shall give Yissum written notice of any Sublicense Consideration received or First Commercial Sale made within thirty (30) days of such event.

8.2 [***].

8.3 On the date prescribed for the submission of each Periodic Report, the Company shall pay the Royalties and Sublicense Fees due to Yissum for the reported period. All payments under this Agreement shall be computed and paid in US dollars, using the appropriate foreign exchange rate reported in the Wall Street Journal on the last working day of the calendar quarter Payment of Value Added Tax — or of any analogous foreign tax, charge or levy (if charged), applicable to the sale of Products shall be added to each payment in accordance with the statutory rate in force at such time Payments may be made by check or by wire transfer to the following account:

[***]

 

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8.4 The Company shall keep, and shall require its Affiliates and Sublicensees to keep, full and correct books of account in accordance with Generally Accepted Accounting Principles as required by international accounting standards enabling the Royalties and Sublicense Fees to be calculated accurately. Starting from the first calendar year after the First Commercial Sale, or the first grant of a Sublicense, whichever occurs first, an annual report, authorized by a certified public accountant, shall be submitted to Yissum within ninety (90) days of the end of each calendar year, detailing Net Sales and Sublicense Considerations, Royalties and Sublicense Fees, both due and paid. Said annual reports shall also include the Company’s sales and royalty forecasts for the following calendar year, if available. This Section 8.4 will mutatis mutandis apply to Yissum in case it will be obligated to pay to the Company any royalties or other payment hereunder.

8.5 Yissum and the Company shall (and the Company shall require and cause its Affiliates and Sublicensees to) retain such books of account for five (5) years after the end of each calendar year during the period of this Agreement, and, if this Agreement is terminated for any reason whatsoever, for five (5) years after the end of the calendar year in which such termination becomes effective.

8.6 [***].

8.7 Yissum shall be entitled to appoint not more than two (2) representatives who must be independent certified public accountants or such other professionals as appropriate (“Yissum Auditors”) to inspect during normal business hours the Company’s and Affiliates’ books of account, records and other relevant documentation to the extent relevant or necessary for the sole purpose of verifying the performance of the Company’s payment obligations under this Agreement, the calculation of amounts due to Yissum under this Agreement and of all financial information provided in the Periodic Reports, provided that Yissum shall coordinate such inspection with the Company or Affiliate (as the case may be) in advance. In addition, Yissum may require that the Company, through Yissum Auditors, inspect during normal business hours the books of account, records and other relevant documentation of any Sublicensees, to the extent relevant or necessary for the sole purpose of verifying the performance of the Company’s payment obligations under this Agreement, the calculation of amounts due to Yissum under this Agreement and of all financial information provided in the Periodic Reports, and the Company shall cause such inspection to be performed. The Parties shall reconcile any underpayment or overpayment within thirty (30) days after the Representatives deliver the results of the audit. Any underpayment shall be subject to interest in accordance with the terms of Section 8.8 hereof In the event that any inspection as aforesaid reveals any underpayment by the Company to Yissum in respect of any year of the Agreement in an amount exceeding five percent (5%) of the amount actually paid by the Company to Yissum in respect of such year, then the Company shall pay the cost of such inspection.

 

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8.8 Any sum of money due to either Party which is not duly paid on time shall bear interest from the due date of payment until the actual date of payment [***].

8.9 Should any payment required to be made to Yissum in accordance with the provisions of this Agreement be subject to withholding of any taxes assessable upon Yissum, the Company shall inform Yissum of such withholding requirement sufficiently in advance of such withholding to allow Yissum to obtain and provide the Company with an appropriate certificate of exemption, if available. The Company shall fully cooperate with Yissum, at Yissum’s expense, in its efforts to obtain such exemption (or in obtaining any refund if applicable). No withholding shall be made if an exemption is obtained All payments made shall be free and clear of any other withholding of any kind.

 

  9.

PATENT REGISTRATION

9.1 Yissum, in consultation with the Company, shall be responsible for the filing, prosecution and maintenance of the Joint Patents, if any, in the Territory, at the Company’s expense (the “Ongoing Patent Costs”) Each application and every patent registration of the Joint Patents shall be made and registered jointly in the name of Yissum and the Company. The Parties shall jointly choose patent counsel who will prosecute and maintain the Joint Patents, The Company agrees to such patent counsel directly bill the Company for such expenses and shall directly pay such bills in accordance with patent counsel’s directions.

9.2 For the avoidance of doubt, the Company will be solely responsible for the filing, prosecution and maintenance of any Patents which cover only Development Results that are not jointly owned with Yissum.

9.3 Notwithstanding the forgoing in Section 9.1 above, upon or immediately after the filing of the first Joint Patent, the Company shall deposit with Yissum the amount [***] to secure the payment of the Ongoing Patent Costs (the “Expense Deposit”). Should the Company fail to pay any amounts due in connection with the Ongoing Patent Expenses within thirty (30) days following receipt of Yissum’s written request accompanied by a detailed account, Yissum shall be entitled to pay the unpaid expenses from the Expense Deposit. In the event that Yissum utilizes some or all of the Expense Deposit as set forth in this section, it shall so notify the Company in writing The Company shall be obligated to deposit with Yissum [***]. The obligation of the Company under this Section 9 2 shall expire in the event that all Joint Patents have been refused, canceled or revoked.

9.4 Subject to the above, the Parties shall consult and make every effort to reach agreement in all respects relating to the manner of making applications and registering the Patents, including the time of making the applications, the countries where applications will be made and all other particulars relating to the registration and maintenance of the Joint Patents Notwithstanding the foregoing, Yissum reserves the sole right, to be exercised reasonably and in good faith, to make all final decisions with respect to the preparation, filing, prosecution and maintenance of such patent applications and patents.

9.5 The Parties shall assist each other in all respects relating to the preparation of documents for the registration of any patent or any patent-related right upon the request of the other Party, Both Parties shall take all appropriate action in order to assist the other to extend the duration of a Joint Patent or obtain any other extension obtainable under law, to maximize the scope of the protection afforded by the Joint Patents.

 

13


9.6 The Company shall give Yissum immediate notice of any approach made to it by a patent examiner or attorney in connection with any matter that is the subject matter of this Agreement. The Company shall only reply to such approaches after consultation with Yissum and subject to its consent.

9.7 The Company, its Affiliates and Sublicensees shall mark all Products covered by one or more of the Joint Patents with patent numbers (or the legend “patent pending”) in accordance with the statutory requirements in the country or countries of manufacture, use and sale. The Company shall require its Sublicensee complies with the provisions of this section.

9.8 [***].

9.9 The foregoing does not constitute an obligation or warranty on the part of Yissum that any Patent will indeed be made or registered or be registrable in respect of the Licensed Technology or any part thereof, nor shall it constitute an obligation, warranty, or declaration on the part of Yissum that a registered patent will afford due protection. For the avoidance of doubt, the provisions of this Agreement do not constitute a representation or warranty on the part of Yissum regarding the validity of or the protection afforded by any of the Patents, and Yissum hereby expresses that it has made no examination as to the validity of the Joint Patents.

 

  10.

PATENT RIGHTS PROTECTION

10.1 The Company and Yissum shall each inform the other promptly in writing of any alleged infringements by a third party of the Joint Patents in the Territory, together with any available written evidence of such alleged infringement.

10.2 The Company, its Affiliate or Sublicensee shall have the right, but not the obligation, to prosecute m its own name and at its own expense any infringement of such Joint Patents. Before the Company, its Affiliate or its Sublicensee commences an action with respect to any infringement, the Company shall give careful consideration to the views of Yissum in making its decision whether or not to sue and, if relevant, make these views known to its Affiliate or Sublicensee The Company (or its Affiliate or Sublicensee, where relevant) shall keep Yissum reasonably apprised of all developments in the action and shall seek Yissum’s input and approval on any substantive submissions or positions taken in the litigation regarding the scope, validity or enforceability of the Joint Patents.

10.3 If the Company, its Affiliate or its Sublicensee elects to commence an action as described above and Yissum is a legally indispensable party to such action, Yissum, at the Company’s expense, may be joined as a co-plaintiff. Regardless of whether Yissum is a legally indispensable party, Yissum, to the extent permitted by law, and at its own cost, may elect to join the action as a co-plaintiff and shall jointly control the action with the Company, its Affiliate or its Sublicensee. Irrespective of whether Yissum joins the action, it shall provide reasonable cooperation to the Company, its Affiliate or its Sublicensee, The Company shall reimburse Yissum for any costs it incurs as part of an action brought pursuant to this section where Yissum has not elected to join the action as a co-plaintiff.

 

14


10.4 [***].

10.5 [***].

10.6 [***].

10.7 If either Party commences an action and then decides to abandon it, such Party will give timely notice to the other Party. The other Party may continue the prosecution of the suit, after both Parties agree on the sharing of expenses.

10.8 [***].

 

  11.

CONFIDENTIALITY; [***]

11.1 The Parties warrant and undertake that during the term of this Agreement and subsequent thereto, they shall maintain full and absolute confidentiality, and shall also be liable for their officers or employees or representatives maintaining absolute confidentiality, concerning all information, details and data which is in or comes to their knowledge or that of their officers, employees, representatives or any person acting on their behalf directly or indirectly relating to the Research, the Licensed Technology, Yissum, the University, the Researchers and their employees or the Company, its officers, employees, representatives or any person acting on its behalf directly or indirectly, The Parties undertake not to convey or disclose anything in connection with the foregoing to any entity without the prior written permission of the disclosing Party.

11.2 The obligation contained in this Section 11 shall not apply to information which is in the public domain as of the date of this Agreement or hereafter comes into the public domain through no fault of the receiving Party, its officers, employees, representatives or persons acting on its behalf.

11.3 Notwithstanding the above, a Party may disclose details and information to its officers, employees, representatives or persons acting on its behalf, Affiliates and Sublicensees, as necessary for the performance of its obligations pursuant to this Agreement, provided that it procures that such Parties execute a confidentiality agreement substantially similar in content to this Section 11.

11.4 Yissum shall procure that the Researchers and any other person connected with it with regard to the License execute a confidentiality agreement substantially similar in content to this Section 11.

11.5 As a precondition to any Sublicense, the Company shall require its Sublicensees to procure that the Sublicensee’s officers, employees, representatives or persons acting on the Sublicensee’s behalf are bound by a written confidentiality agreement substantially similar in content to this Section 11.

 

15


11.6 The provisions of this Section 11 shall be subject to permitted publications pursuant to section 13, below.

11.7 The above provisions of this Section 11 notwithstanding, the Company shall be entitled to disclose the information set forth below to any potential investors, sublicensee, IP providers, strategic or other business partners, provided that they have executed a confidential disclosure agreement substantially similar to this Section 11, Such permitted disclosure will refer to any materials or data as may be required in a due diligence process.

11.8 [***].

 

  12.

PUBLICATIONS

12.1 Yissum shall ensure that no publications in writing, in scientific journals or orally at scientific conventions relating to the Licensed Technology, the Research Results, the Development Plan, the Development Results or any Product, are published by it or its Researchers, without first seeking the consent of the Company.

12.2 The Company undertakes to reply to any such request for publication by Yissum within thirty (30) days of its receipt of a request in connection with the publication of articles in scientific journals, and within thirty (30) days of its receipt of a request in connection with article abstracts. The Company may only decline such an application upon reasonable grounds, which shall be fully detailed in writing.

12.3 Should the Company decide to object to publication as provided in Section 12,2, publication shall be postponed for a period of not more than sixty (60) days from the date the publication was sent to the Company to enable the filing of patent applications or the removal of the Company’s confidential information. The Company may withhold publication for an additional period of eleven (11) months at its discretion, subject to written notification to Yissum, thereafter the publication will be automatically permitted.

12.4 The provisions of this Section 12 shall not prejudice any other right, which Yissum has pursuant to this Agreement or at law.

12.5 For the avoidance of doubt, the provisions of this section in connection with the prohibition against publication shall not apply to internal publication made in the University for the Researchers and University employees provided that such persons are subject to written obligations of confidentiality substantially similar to those set forth in Section 11 hereof.

12.6 The Parties will ensure that any agreements with third parties concerning the Licensed Technology, the Research Results, the Development Plan, the Development Results or the Products include provisions substantially similar to this Section 12.

 

16


  13.

LIABILITY AND INDEMNITY

13.1 YISSUM MAKES NO WARRANTIES OF ANY KIND WITH RESPECT TO THE LICENSED TECHNOLOGY. IN PARTICULAR, YISSUM MAKES NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE LICENSED TECHNOLOGY WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK OR OTHER RIGHTS OF ANY THIRD PARTY. IN ADDITION, NOTHING IN THIS AGREEMENT MAY BE DEEMED A REPRESENTATION OR WARRANTY BY YISSUM AS TO THE VALIDITY OF ANY OF THE PATENTS OR THEIR REGISTRABILITY OR OF THE ACCURACY, SAFETY, EFFICACY, OR USEFULNESS, FOR ANY PURPOSE, OF THE LICENSED TECHNOLOGY. YISSUM HAS NO OBLIGATION, EXPRESS OR IMPLIED, TO SUPERVISE, MONITOR, REVIEW OR OTHERWISE ASSUME RESPONSIBILITY FOR THE PRODUCTION, MANUFACTURE, TESTING, MARKETING OR SALE OF ANY PRODUCT OR SERVICE [***].

13.2 [***].

13.3 [***].

13.4 The Company shall procure and maintain, at its sole cost and expense, to the extent that it is commercially reasonable to do so, policies of comprehensive general liability insurance in amounts not less than is customary in its industry. Such policy shall name the Indemnitees as additional insureds. Such comprehensive general liability insurance shall provide (a) product liability coverage and (b) broad form contractual liability coverage for the Company’s indemnification obligations under this Section 13. The insurance coverage required above shall not be construed to create a limit of the Company’s liability with respect to its indemnification obligations under this Section 13.

13.5 The Company shall provide Yissum with written evidence of such insurance upon request. The Company shall provide Yissum with written notice at least sixty (60) days prim to the cancellation, non-renewal or material change in such insurance If the Company does not obtain replacement insurance providing comparable coverage within such fifteen (15) day period, Yissum shall have the right to terminate this Agreement effective at the end of such fifteen (15) day period without notice or any additional waiting periods.

13.6 The Company shall maintain, at its own expense, liability insurance as set forth in Section 13 4 hereof, beyond the expiration or termination of this Agreement as long as a Product relating to or developed pursuant to this Agreement is being commercially distributed or sold by the Company, an Affiliate or a Sublicensee.

 

  14.

TERMINATION OF THE AGREEMENT

14.1 Notwithstanding any provisions to the contrary by law, this Agreement may be terminated only upon the circumstances set forth in this Section 14.1 below (without prejudice to the Parties’ right to pursue remedies available by law other than termination).

(a) By either Party giving written notice to the other, in which case termination will become effective immediately upon receipt by the other Party of such written notice, if (w) the other Party passes a resolution for voluntary winding up or a winding up application is made against it and not set aside within ninety (90) days, or (x) a receiver or liquidator is appointed for the other Party unless the order or decision effectuating such

 

17


appointment is set aside within ninety (90) days of the date such order or decision; or (y) the other Party enters into winding up or insolvency or bankruptcy proceedings and such proceedings are not set aside within ninety (90) days, or (z) an attachment is made over all or substantially all of the other Party’s assets or if execution proceedings are taken against the other Party and the same are not set aside within ninety (90) days of the date the attachment is made or the execution proceedings are taken Each of the Parties undertakes to notify the other within seven (7) days if any of the abovementioned events occur; or

(b) By Yissum giving written notice to the Company in the following circumstances, if the pertinent circumstance is not cured within ninety (90) of receipt of Yissum’s notice requiring the Company to do so.

(i) In the circumstances set out in Section 5.4 hereof.

(ii) Uncured lapse of insurance coverage (if insurance policies are to be obtained and maintained in accordance with Section 13.4 hereof) under Section 13 5 hereof unless such lapse was covered (retroactively if necessary); or

(iii) Commercially unreasonable failure to respond to third party claims as required under Section 10 hereof.

14.2 Upon the occurrence of any of the events set forth in Section 14.1(a) hereof or in the event that the Company is insolvent, declared bankrupt, is voluntarily or involuntarily dissolved, or otherwise ceases operations, excluding, however, dissolution or cessation of operations which result from an M&A transaction or the sale of all or substantially all of the assets of the Company, (each, a “Company Cessation Event”), the following provisions will apply.

(a) Some or all of the Company’s shareholders, but acting as a single group, shall be entitled, but not obligated, to assume the Company’s rights and obligations pursuant to this Agreement, either directly or through a new corporate entity (“Company Shareholders Option”), in which case the Company’s interest in the Joint IP shall be transferred to them or to such new corporate entity, as appropriate.

(b) Should the Company Shareholders Option not be exercised, ownership of the Company’s interest in the Joint IP shall be transferred and assigned to Yissum in accordance with the letter of assignment m the form annexed hereto as Appendix E, which shall then be free to license the Joint IP to others as it sees fit.

(c) [***].

14.3 Upon termination of the Agreement for any other reason than those referenced in Section 14 2 hereof; the License will terminate and the Licensed Technology and all rights included therein shall revert to Yissum. In addition, the Company, or its successors or assigns, shall grant Yissum an exclusive, perpetual, irrevocable, royalty-free license to its interest in the Joint IP and Yissum shall thereafter be free to enter into agreements with any other third parties for the granting of a license or to deal in any other manner with the Licensed Technology and the Joint IP as it shall see fit with no further obligation to the Company, or its successors or assigns.

 

18


14.4 If this Agreement is duly terminated, and the Company Shareholders Option is not exercised (if termination is made for Company Cessation Event), then upon termination of the Agreement, the Company shall return or transfer to Yissum, within thirty (30) days of termination of the Agreement, all material, in soft or hard copy, relating to the Licensed Technology, and it may not make any further use thereof. In case of termination as set forth herein, the Company will not be entitled to any reimbursement of any amount paid to Yissum under this Agreement with respect to such terminated portion of the License. Yissum shall be entitled to conduct an audit in order to ascertain compliance with this provision and the Company agrees to allow reasonable access to Yissum or its representatives for this purpose.

14.5 Sections 3, 4.2, 7, 8, 9, 10, 11, 13, 14, 15 and 16 hereof shall survive the termination of this Agreement to the extent required to effectuate the intent of the Parties as reflected in this Agreement.

 

  15.

LAW

The provisions of this Agreement and everything concerning the relationship between the Parties in accordance with this Agreement shall be governed by Israeli law and jurisdiction shall be granted only to the appropriate court in Tel Aviv. The Company undertakes not to object to the enforcement against it of writs and decisions issued by any other jurisdiction outside the State of Israel under such circumstances. The Company hereby waives any immunity it may have against enforcement of any judgment obtained against it by Yissum.

 

  16.

ARBITRATION

16.1 Notwithstanding and in addition to the provisions of Section 15 hereof, all differences of opinion and disputes arising between the Parties in connection with the Agreement or its interpretation or its performance or breach, shall be referred for the decision of a single arbitrator, whose identity shall be determined by mutual consent of the Parties.

16.2 Should the Parties not reach agreement as to the identity of the arbitrator within fourteen (14) days of request by either Party for the appointment of an arbitrator, the arbitrator shall be appointed by the Chairman of the Israel Bar Association on the application of either of the Parties. In any event, in any disputes concerning issues of intellectual property rights the arbitrator will be a patent attorney.

16.3 The arbitration shall be held in Israel. The proceedings before and all documents submitted to such arbitrator shall be in the English language. The arbitrator shall not be bound by the civil procedure regulations and laws of evidence but shall base his/her decision on the substantive law of Israel and shall give grounds for his/her decision. The arbitrator shall be empowered to grant temporary injunctions and orders, which shall be enforceable in foreign jurisdictions, in accordance with Section 15 hereof.

 

19


16.4 The decision of the arbitrator shall be final and binding upon the Parties, and shall be enforceable in foreign jurisdictions.

16.5 The execution of this Agreement shall constitute the execution of an Arbitration Agreement.

 

  17.

MISCELLANEOUS

17.1 Relationship of the Parties. It is hereby agreed and declared between the Parties that they shall act in all respects relating to this Agreement as independent contractors and there neither is nor shall there be any employer-employee or principal-agent relationship or partnership relationship between the Company (or any of its employees) and Yissum. Each Party will be responsible for payment of all salaries and taxes and social welfare benefits and any other payments of any kind in respect of its employees and officers, regardless of the location of the performance of their duties, or the source of the directions for the performance thereof.

17.2 Assignment. The Parties may not transfer or assign or endorse their rights or duties or any of them pursuant to this Agreement to another, without the prior written consent of the Party, which consent shall not be unreasonably denied, conditioned or delayed.

17.3 No Waiver. The failure or delay of a Party to the Agreement to claim the performance of an obligation of the other Party shall not be deemed a waiver of the performance of such obligation or of any future obligations of a similar nature.

17.4 Representation by Legal Counsel. Each Party represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in drafting tins Agreement. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption shall exist of be implied against the Party which drafted such terms and provisions.

17.5 Legal Costs. Each Party shall bear its own legal expenses involved in the making of this Agreement.

17.6 Taxes. Monetary amounts mentioned in this agreement do not include VAT. All taxes and duties to be paid in connection with this Agreement by the Company, including any VAT, shall be borne by the Company. Any duties or taxes payable by Yissum in connection with this Agreement shall be paid by Yissum.

17.7 Force Majeure. Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached the Agreement for failure or delay in fulfilling or performing any term of this Agreement to the extent, and for so long as, such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party including but not limited to fires, earthquakes, floods, embargoes, wars, acts of war (whether war is declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, acts of God or acts, omissions or delays in acting by any governmental authority or other Party provided that the nonperforming Party uses commercially reasonable efforts to avoid or remove such causes of nonperformance and continues performance under this Agreement with reasonable dispatch whenever such causes are removed. The Party affected by such circumstances shall promptly notify the other Party in writing when such circumstances cause a delay or failure in performance and when they cease to do so.

 

20


17.8 Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original.

17.9 Binding Effect. This Agreement shall be binding upon the Parties once executed by both Parties and shall enter into force and become effective as of the later of the signature dates.

17.10 Entire Agreement. This Agreement constitutes the full and complete agreement between the Parties and supersedes any and all agreements or understandings, whether written or oral, concerning the subject matter of this Agreement (including, but not limited to, the MOU), and may only be amended by a document signed by both Parties.

17.11 Notices. All notices and communications pursuant to this Agreement shall be made in writing and sent by facsimile or by registered mail or served personally at the following addresses:

Yissum

Yissum Research Development Company

of the Hebrew University of Jerusalem,

P.O. Box 39135,

Jerusalem 91390

Israel

BEEOLOGICS, INC.

11800 SW 77th Avenue, Miami Florida 33156, USA

Att: Eyal Ben-Chanoch

 

21


or such other address furnished in writing by one Party to the other. Any notice served personally shall be deemed to have been received on the day of service, any notice sent by registered mail as aforesaid shall be deemed to have been received seven days after being posted by prepaid registered mail. Any notice sent by facsimile shall be deemed to have been received by the next business day after receipt of confirmation of transmission.

IN WITNESS THE HANDS OF THE PARTIES

 

YISSUM       THE COMPANY
By:  

/s/ Ziv Shomroni

      By:  

/s/ Eyal Ben-Chanoch

Name:   Ziv Shomroni       Name:   Eyal Ben-Chanoch
Title:   VP Licensing Agricultural & Natural Science                Title:   President & CEO
Date:  

                     

      Date:  

                          

I the undersigned, Prof Ilan Sela, have reviewed, am familiar with and agree to all of the above terms and conditions including, but not limited to the non-compete provisions set forth in Section 11.8, above. I hereby undertake to cooperate fully with Yissum in order to ensure its ability to fulfill its obligations hereunder, as set forth herein.

 

/s/ Ilan Sela

             

October 22, 2010

Prof. Ilan Sela      Date signed

 

22


or such other address furnished in writing by one Party to the other. Any notice served personally shall be deemed to have been received on the day of service, any notice sent by registered mail as aforesaid shall be deemed to have been received seven days after being posted by prepaid registered mail. Any notice sent by facsimile shall be deemed to have been received by the next business day after receipt of confirmation of transmission.

IN WITNESS THE HANDS OF THE PARTIES

 

YISSUM     THE COMPANY
By:  

 

    By:  

/s/ Eyal Ben-Chanoch

Name:  

 

         Name:   Eyal Ben-Chanoch
Title:  

 

    Title:   President & CEO
Date:  

 

    Date:  

 

I the undersigned, Prof Ilan Sela, have reviewed, am familiar with and agree to all of the above terms and conditions including, but not limited to the non-compete provisions set forth in Section 11.8, above. I hereby undertake to cooperate fully with Yissum in order to ensure its ability to fulfill its obligations hereunder, as set forth herein.

 

/s/ Ilan Sela

         

October 22, 2010

Prof. Ilan Sela      Date signed

 

23


[***]

A-1 — Company IP

 

1.

[***]

 

2

Relative portion in Joint IP.

A-2 — Yissum IP

Relative portion in Joint IP

A-3 — Joint IP

 

1

Provisional patent application: No. 61/251,339 : By: HUJI (Eyal Maori, Ilan SELA, Nitzan Paldi, Ethan Glick, Eyal Ben-Chanoch and Gal Yarden); Title: COMPOSITIONS FOR CONTROLLING VARROA MITES IN BEES. The patent resulting from said patent application will be jointly owned by Yissum and the Company [***].

 

2.

Other Research Results, including Know-How.

 

YISSUM          THE COMPANY
By:  

/s/ Yaacov Michlin

    By:  

/s/ Eyal Ben-Chanoch

Name:   President & CEO     Name:   Eyal Ben-Chanoch
Title:  

 

    Title:   President & CEO
Date:  

 

    Date:  

 

I the undersigned, Prof Ilan Sela, have reviewed, am familiar with and agree to all of the above terms and conditions. I hereby undertake to cooperate fully with Yissum in order to ensure its ability to fulfill its obligations hereunder, as set forth herein.

 

/s/ Ilan Sela

         

 

Prof. Ilan Sela      Date signed

 

24


EXHIBIT A — INTELLECTUAL PROPERTY

A-1 — Company IP

 

1.

[***]

 

2

Relative portion in Joint IP.

A-2 — Yissum IP

Relative portion in Joint IP

A-3 — Joint IP

 

1

Provisional patent application: No. 61/251,339 : By: HUJI (Eyal Maori, Ilan SELA, Nitzan Paldi, Ethan Glick, Eyal Ben-Chanoch and Gal Yarden); Title: COMPOSITIONS FOR CONTROLLING VARROA MITES IN BEES. The patent resulting from said patent application will be jointly owned by Yissum and the Company in proportions of 50%—Yissum and 50%—the Company and an assignment with respect thereto will be executed m favor of both Yissum and the Company.

 

2.

Other Research Results, including Know-How.

 

YISSUM     

THE COMPANY

By:  

 

             

By: [***]

Name:  

 

    

Name: [***]

Title:  

 

    

Title: [***]

Date:  

 

    

Date: [***]

[***]

[***]

 

25

Exhibit 10.31

Certain identified information has been omitted from this exhibit because it is

not material and of the type that the registrant treats as private or confidential.

[***] indicates that information has been omitted.

ASSIGNMENT AGREEMENT

THIS ASSIGNMENT AGREEMENT, effective as of December 10, 2020 (the “Assignment”), is made by and between BEEOLOGICS, INC., having its principal business offices at 800 North Lindbergh Boulevard, St. Louis, Missouri 63167 (“Assignor”), and GREENLIGHT BIOSCIENCES, INC., having its principal business offices at 200 Boston Ave. Suite 1000, Medford, MA 02155 (“Assignee”).

WHEREAS, Assignor entered into a License and Sponsored Research Agreement dated April 2010 (the “Bee Health License”) with Yissum Research Development Company of the Hebrew University of Jerusalem LTD. (“Yissum”);

WHEREAS, Assignor and Assignee are parties to an Assignment and License Agreement dated as of December 10, 2020 (the “Agreement”), pursuant to which, among other things, Assignor has agreed to assign and deliver to Assignee, and Assignee has agreed to accept, all of Assignor’s right, title, interest, and obligations in and to the Bee Health License; and

WHEREAS, Yissum has consented to the assignment of the Bee Health License to Assignee, such consent attached as Exhibit A.

NOW THEREFORE, for good and valuable consideration acknowledged by Assignor to have been received in full from Assignee and pursuant to the terms of the Agreement, Assignor and Assignee hereby agrees as follows:

1. Assignor hereby conveys, transfers, assigns, and delivers unto Assignee, absolutely and forever, all of Assignor’s right, title, interest, obligations, responsibilities, and duties in and to the Bee Health License.

2. Assignee hereby accepts the assignment of all of Assignor’s obligations, responsibilities, and duties under the Bee Health License and all of Assignor’s right, title, and interest in and to the Bee Health License. All terms and conditions of the Bee Health License shall remain in full force and effect.

3. Notwithstanding any other provisions of this Assignment to the contrary, nothing contained in this Assignment shall in any way supersede, modify, replace, amend, change, rescind, waive, exceed, expand, enlarge, or in any way affect the provisions, including warranties, covenants, agreements, conditions, representations, or in general any of the rights and remedies, or any of the obligations and indemnifications of Assignor or Assignee set forth in the Agreement. This Agreement is intended only to effect the transfer of certain property transferred pursuant to the Agreement and shall be governed entirely in accordance with the terms and conditions of the Agreement.

4. This Assignment shall be binding on, and shall inure to the benefit of, Assignor, Assignee, and their respective successors and/or assigns, and all others acting by, through, with, or under their direction, and all those in privity therewith.


IN WITNESS WHEREOF, Assignee has caused this Assignment to be executed by its duly authorized representatives effective this 17 day of December, 2020.

 

BEEOLOGICS, INC.
By:  

/s/ Deryck Jeremy Williams

Name:   Deryck Jeremy Williams
Title:   Director of Beelogics, Inc.

[Signature Page to Assignment]


IN WITNESS WHEREOF, Assignee has caused this Assignment to be executed by its duly authorized representatives effective this      day of         , 2020.

 

GREENLIGHT BIOSCIENCES, INC.

By:  

/s/Andrey Zarur

Name:   Andrey Zarur
Title:   President & CEO

[Signature Page to Assignment]


Exhibit 10.31

EXHIBIT A

 

LOGO

Sent Via Fax: fax no. [***]

Yissum Research and Development Company of the Hebrew

University of Jerusalem (hereinafter “Yissum”)

Hi-Tech Park, Edmond J Safra Campus Givat-Ram, Jerusalem

Jerusalem 91390

Israel

SUBJECT: NOTICE OF ASSIGNMENT

Dear Yissum:

We refer to the License and Sponsored Research Agreement (as extended, renewed, amended or restated from time to time, the “Agreement”), dated March 15, 2013 between Beeologics, Inc. (a wholly owned subsidiary of Monsanto Company (hereinafter “Monsanto”), which is a wholly owned subsidiary of Bayer AG) and Yissum. Pursuant to Section 17.2 of the Agreement, we hereby give you notice of that Monsanto desires to assign the Agreement and all rights and interests thereto to GreenLight Bioscience, Inc. (hereinafter “GreenLight”). GreenLight agrees to assume such rights and obligations, such assignment and assumption to be effective on December 7, 2020. We therefore request Yissum’s express written consent of such assignment, which, pursuant to Section 17.2, such consent shall not be unreasonably denied, conditioned or delayed.

In order to ensure that the Agreement can be continued without interruption, we would like to ask you to duly sign below and return this letter to Bayer Crop Science LLP, 800 North Lindbergh Boulevard, St. Louis, MO, USA, Attn: Amanda Carmany-Rampey, Associate General Counsel Intellectual Property & Licensing with a copy emailed to [***] at your earliest convenience. Your


signature will serve as your consent to the assignment and assumption of the Agreement, acknowledgement that this letter constitutes sufficient notice of the assignment and assumption of the Agreement and irrevocable waiver of any termination rights you may have according to the Agreement as a result of the assignment and assumption.

Sincerely,

Amanda Carmany-Rampey

Assistant General Counsel

Intellectual Property & Licensing

Bayer Crop Science

 

Agreed to and accepted this      day of             , 2020.
Yissum Research and Development Company of the Hebrew University of Jerusalem
By:  

 

Title:  

 

Exhibit 10.33

Certain identified information has been omitted from this exhibit because it is

not material and of the type that the registrant treats as private or confidential.

[***] indicates that information has been omitted.

MASTER SERVICES AGREEMENT

between

SAMSUNG BIOLOGICS CO., LTD.

And

GREENLIGHT BIOSCIENCES, INC.

 

1


Table of Contents

 

SECTION 1

  DEFINITIONS      3  

SECTION 2

  RELATED AGREEMENTS AND EXHIBITS      11  

SECTION 3

  MANAGEMENT OF SERVICE      11  

SECTION 4

  SERVICE DESCRIPTIONS      13  

SECTION 5

  CHANGES TO THE SPECIFICATIONS, ANALYTICAL METHODS, MANUFACTURING PROCESS, FACILITY OR EQUIPMENT      19  

SECTION 6

  REGULATORY APPROVALS AND INSPECTIONS      20  

SECTION 7

  QUALITY COMPLIANCE      21  

SECTION 8

  CONSIDERATION AND PAYMENT TERMS      21  

SECTION 9

  CONFIDENTIALITY      23  

SECTION 10

  OWNERSHIP OF MATERIALS AND INTELLECTUAL PROPERTY      25  

SECTION 11

  WARRANTIES.      25  

SECTION 12

  INDEMNIFICATION      26  

SECTION 13

  DISCLAIMER OF CONSEQUENTIAL DAMAGES; LIMITATION OF LIABILITY      27  

SECTION 14

  TERM AND TERMINATION OF AGREEMENT      28  

SECTION 15

  ARBITRATION      31  

SECTION 16

  MISCELLANEOUS      31  

 

2


Certain identified information has been omitted from this exhibit because it is

not material and of the type that the registrant treats as private or confidential.

[***] indicates that information has been omitted.

MASTER SERVICES AGREEMENT

This Master Services Agreement (this “MSA”) is made and entered into as of the date of last signature below (the “Effective Date”) by and between Greenlight Biosciences, Inc., a Delaware corporation having its principal place of business at 200 Boston Avenue, Suite 1000, Medford, MA 02155 (“Client”), and Samsung Biologics Co., Ltd., a Korean corporation having its principal place of business at 300, Songdo bio-daero, Yeonsu-gu, Incheon, 21987, Republic of Korea (“SBL”). Client and SBL are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

WHEREAS, Client and SBL wish to enter into a business relationship whereby SBL will provide Client with certain services related to pharmaceutical development and/or manufacturing;

NOW, THEREFORE, in consideration of the mutual promises, covenants and agreements hereinafter set forth and for other valuable consideration, the Parties agree as follows:

SECTION 1 DEFINITIONS

Each of the following capitalized terms as used in this MSA, whether in the singular or plural, shall have the respective meanings set forth below.

 

1.1

“Acceptance Procedure” means the review of the Batch Related Documents and any reasonably necessary test(s) of a Batch of Product which are performed to verify that the Product meets the Specifications and complies with Regulatory Authority requirements, which are conducted by Client before or after SBL’s release of a Batch of Product in accordance with the applicable PSA and QAG.

 

1.2

“Affected Party” means the Party affected by Force Majeure under Section 16.3.

 

1.3

“Affiliate” means any corporation, company, partnership or other entity which directly or indirectly, controls, is controlled by or is under common control with either Party hereto. A corporation or other entity shall be regarded as controlling another corporation or other entity if it owns or directly or indirectly controls more than fifty percent (50%) of the voting stock or other ownership interest of the corporation or other entity, or if possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of the corporation or other entity or the power to elect or appoint more than fifty percent (50%) of the members of the governing body of the corporation or other entity.

 

1.4

“Annual Service Fees” means the total Service Fees paid or payable by Client to SBL in a given calendar year (excluding costs of Raw Materials, SBL handling fees, and other expense or cost reimbursements) pursuant to a particular Product Specific Agreement.

 

1.5

“Applicable Laws” means any and all laws, rules, or regulations of any jurisdiction which are applicable to the Parties in carrying out activities described in this MSA or any PSAs that may be in effect from time to time.

 

3


1.6

“Assignment”, “Assigning”, or to “Assign” means a merger, change of control, sale of stock, inheritance of stock, transfer of all or substantially all of the assets, or transfer of all or substantially all rights to any Product.

 

1.7

“Background IP” means any Intellectual Property related to a Product and/or its use, or the Manufacture of such Product, in each case, which is owned and/or controlled by such Party prior to the Effective Date.

 

1.8

“Batch” means one lot of Bulk Drug Product.

 

1.9

“Batch Failure” means that all of a Batch is Non-Conforming Product as reasonably determined by the Core Team during Manufacture of a Batch and prior to SBL’s Batch release.

 

1.10

“Batch Record”, if not defined in the applicable QAG, means the document, proposed by SBL and approved by Client in writing, which defines the manufacturing methods, test methods, and other procedures, direction, and controls associated with the manufacture and testing of a Batch.

 

1.11

“Batch Related Documents” means Manufacturing Documentation in support of SBL’s release of a Product.

 

1.12

“Bulk Drug Product” means formulated Drug Substance, which is Drug Substance encapsulated in a delivery medium such as liquid nano particles.

 

1.13

“Certificate of Analysis”, if not defined in the applicable QAG, means a document prepared by SBL listing tests performed by SBL or an External Laboratory certifying that a particular Batch of Product meets the applicable Specifications, and the results of such tests.

 

1.14

“Certificate of Compliance” means a document prepared by SBL with respect to a particular Batch that verifies completion of all operations in accordance with the Batch Record and cGMP, if applicable and was processed in accordance with the QAG and Applicable Laws.

 

1.15

“Change” means any modification, alteration, adjustment, or correction to the Manufacturing Process, Services, or Specifications.

 

1.16

“Client” is defined in the preamble.

 

1.17

“Client Invention” means any Invention that is conceived and first reduced to practice by either Party which is derived from, or arises out of Client Technology, Client Background IP or Client’s Confidential Information or any other proprietary right of Client.

 

1.18

“Client Materials” means Client reagents and other materials supplied by Client or its third party supplier as set forth in the applicable PSA to be used in the Service hereunder.

 

 

4


1.19

“Client Technology” means means (A) Client Materials and any intermediates, components, or derivatives of Client Materials; (B) Products and any works-in-progress, components, or derivatives of Product; (C) Specifications; (D) test methods provided by Client for use in the Services; (E) the Technology of Client, and all know-how, technology, research and other information of Client including and relating to the Services, Manufacturing Process, analytical methods, quality control analysis, specifications, transportation and storage requirements provided by Client to SBL in connection with this MSA and applicable PSA.

 

1.20

“Clinical Product” means Product which is Manufactured by SBL pursuant to a PSA and which is to be used by Client in a research study or studies that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

 

1.21

“Commercial Product” means Product which is Manufactured by SBL which is intended for commercial sale and use by humans and for importation or exportation into countries or regions designated in each PSA. Notwithstanding the foregoing, any Batches manufactured prior to PAI and including PAI Batches (if applicable) shall not be considered Commercial Product until such PAI even if such Batches are intended for commercial sale and human use.

 

1.22

“Commercially Reasonable Efforts” means with respect to an activity to be carried out by a Party pursuant to this MSA, the carrying out of such activity in a diligent manner, and using efforts and resources comparable to the efforts and resources commonly used in the contract manufacturing of pharmaceutical products (in the case of SBL) or in the biopharmaceutical industry (in the case of Client) by companies with resources and expertise similar to those of such Party. “Commercially Reasonable Efforts” requires prompt assignment of responsibility for such task or activity to specific qualified employee(s) and allocation of resources designed to advance progress with respect to such task or activity but does not require the taking of actions (a) which would require or is likely to require a material adverse change in such Party’s business strategy, existence or solvency, or significant assets, (b) disproportionate to the benefits received under this MSA, or (c) would require either Party to violate Applicable Laws or break any existing contractual commitments with third parties which were entered into by prior to the Effective Date.

 

1.23

“Confidential Information” means any and all scientific, business, financial, contractual, marketing and technical information of or about a party or a Product which has been or may be disclosed, or to which access is provided, by such party (“Disclosing Party”) or any of its representatives to the other Party (“Receiving Party”) or any of its representatives, which (a) if in writing, is marked “confidential”, “proprietary” or other similar marking at the time of disclosure, or (b) if provided orally or visually, is identified as confidential at the time of disclosure and confirmed in writing to Receiving Party within fifteen (15) days of such disclosure, or (c) Receiving Party knows or has reason to know is confidential, trade secret or proprietary information of the Disclosing Party at the time of disclosure. For clarity, the existence and terms of this MSA shall be deemed to be the Confidential Information of both Parties.

 

1.24

“Core Team” means a committee composed of an equal number of representatives from each of SBL and Client to oversee, review, and coordinate the day-to-day performance of the Services and/or Manufacture with the goal of ensuring effective communication between the Parties.

 

5


1.25

“Critical Raw Material” means any Raw Materials with significant financial value and importance, as reasonably agreed between the Parties. Critical Raw Materials shall be specified in the applicable PSA.

 

1.26

“Current Good Manufacturing Practices” or “cGMP” means current good manufacturing practices and regulations applicable to the Manufacture of Product that are promulgated by any Regulatory Authority, including as promulgated under and in accordance with (i) the U.S. Federal Food, Drug and Cosmetic Act, Title 21 of the U.S. Code of Federal Regulations, Parts 210, 211, 600, 601 and 610, (ii) relevant EU legislation, including European Directive 2003/94/EC or national implementations of that Directive, (iii) relevant guidelines, including the EU Guidelines for Good Manufacturing Practices for Medicinal Products (Eudralex Vol. 4 and Annexes thereto), (iv) International Conference on Harmonisation Good Manufacturing Practice Guide for Active Pharmaceuticals Ingredients and (v) and any analogous set of regulations, guidelines or standards as defined, from time to time, by any relevant Regulatory Authority having jurisdiction over the development, manufacture or commercialization of the Product, as applicable, in each case as in effect as of the date such manufacturing for the Product are or were conducted.

 

1.27

“Customized or Dedicated Raw Materials” means any Raw Materials that (a) require customization or specific testing and/or (b) are dedicated just for Client and not intended to be used across multiple product or customers.

 

1.28

“Damages” means any direct damages, costs, expenses, fines, penalties (including reasonable attorneys’ fees and costs), losses and liabilities.

 

1.29

“Decision Memo” means a binding memorandum summarizing and memorializing the Parties’ discussion, understanding, and agreement as to any aspect of the Manufacture that are not directly and/or specifically elaborated in the MSA, PSA, or any previous Decision Memo.

 

1.30

“Fill/Finish Product” means a finished or intermediate dosage form such as vial or pre-filled syringe that contains a Bulk Drug Product, generally, but not necessarily, in association with one or more other ingredients.

 

1.31

“Drug Substance” means an mRNA-based active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body.

 

1.32

“Effective Date” is defined in the preamble.

 

1.33

“EMA” means the European Medicines Agency, or any successor agency.

 

1.34

“Engineering Batch” means a Batch manufactured prior to Commercial Products with the purpose of confirming successful transfer and/or implementation of the Manufacturing Process to the Facility.

 

6


1.35

“External Laboratory” means a third party laboratory instructed by SBL, with Client’s prior consent, to conduct activities required to complete certain Services as discussed and agreed upon by the Parties.

 

1.36

“Facility” means one or more of the facilities of SBL where the Services shall be performed, as further specified in each PSA.

 

1.37

“FDA” means the United States Food and Drug Administration or any successor agency thereto.

 

1.38

“Firm Period” means the portion of the Forecast that is binding on both Parties.

 

1.39

“Forecast” means a projection of Client’s requirements for delivery of Product.

 

1.40

“Force Majeure Event” means any event or occurrence which is beyond the non-performing Party’s reasonable control, including fire, explosion, flood, landslide, epidemics, or other acts of God; acts, regulations, export and/or import restrictions, embargos (including but not limited to those promulgated by any U.S. Regulatory Authority), or laws of any government; terrorism, war; failure of public utilities; acts of decisions of duly constituted municipal, state, national or supra-national governmental authorities or of courts of law; or impossibility to obtain Raw Materials, equipment, supplies, fuel or other required materials or the occurrence of other supply or manufacture interruptions (at its and/or third-party facilities), in spite of having acted with Commercially Reasonable Efforts.

 

1.41

“Implementation Plan and Budget” means an estimated plan and budget of the reasonable and necessary costs that would be incurred by SBL as a result of the implementation of any such Change(s), including, but not limited to (i) process and analytical development; (ii) equipment and/or the Facility modifications, qualification, validation, maintenance, and decommissioning/disposal; (iii) process and analytical validation; (iv) document revisions or changes, the Facility, equipment, and system modifications or changes; (v) additional stability testing; and (vi) preparing submissions to Regulatory Authorities.

 

1.42

“Indemnified Party” means the Party claiming indemnification under Sections 12.3 and 13.2.

 

1.43

“Indemnifying Party” means the Party subject to an indemnification claim from the other Party.

 

1.44

“Intellectual Property” means: (i) patents, trade secrets, copyrights, trademarks, trade names and domain names, rights in designs, rights in computer software, database rights, know-how, and any other intellectual property rights, in each case whether registered or unregistered; (ii) all applications (or rights to apply) for, and renewals or extensions of, any of the rights described in the foregoing sub-clause (i); and (iii) all rights and applications that are similar or equivalent to the rights and applications described in the foregoing sub-clauses (i) and (ii), which exist now, or which come to exist in the future, in any part of the world.

 

1.45

“Invention” means any Intellectual Property created by either Party which arises out of or results from the Services under the MSA.

 

7


1.46

“Joint Steering Committee” or “JSC” means a committee composed of an equal number of representatives from each of SBL and Client, generally at least Director-level or equivalent to provide guidance to the Core Team and resolve any issues or disputes which in good-faith are not able to be resolved by the Core Team.

 

1.47

“Manufacturing” or to “Manufacture” means the manufacturing of a Batch of Product, and any services relating to such manufacturing, including, but not limited to, testing, quality control, documentations, archiving, and packaging, and up to release of the Batch of Product, to be performed by SBL under the MSA and any applicable PSA.

 

1.48

“Manufacturing Documentation” means with respect to a given Batch of Product, the data acquired and generated, documents and records describing or otherwise related to the Manufacturing Process.

 

1.49

“Manufacturing Process” means the mutually agreed production process for the Manufacturing of a Batch the Product.

 

1.50

“Non-Affected Party” means the Party other than the Affected Party under Section 16.3.

 

1.51

“Non-Conforming Product” means a Batch of Product that fails to conform to the Specifications, or other mutually agreed upon written express requirements for SBL to follow, resulting in a materially adverse impact on the quality of Product as reasonably determined by the relevant document, record, or data.

 

1.52

“Other Raw Material” means any Raw Material other than Critical Raw Material and Customized or Dedicated Raw Material.

 

1.53

“Party” and “Parties” is defined in the preamble.

 

1.54

“Pre-Approval Inspection” or “PAI” means an on-site inspection of the Facility by the Regulatory Authority prior to granting the Regulatory Approval for Commercial Product as required by various Regulatory Authorities to ensure that the Manufacturing Process and the Facility meet the appropriate requirements and comply with cGMP.

 

1.55

“Process Validation Batch” means a Batch of Product produced by SBL hereunder to (i) demonstrate and document the consistency and reproducibility of the Manufacturing Process at the Facility, and (ii) support the Regulatory Approval of both the Product Manufactured and the Manufacturing Process at the Facility.

 

1.56

“Product” means Clinical Product or Commercial Product to be Manufactured by SBL pursuant to this MSA and any applicable PSA.

 

1.57

“Product-in-process” means any unfinished Product under the Manufacturing Process.

 

8


1.58

“Product Purchase Commitment” means the minimum number of Batches that Client shall be obligated to purchase in any given calendar year.

 

1.59

“Product Specific Agreement” or “PSA” means a separate agreement specific to each Product and/or Services entered into and mutually agreed from time to time by duly authorized representatives of the Parties. Each PSA shall be governed by and be integrated into this MSA and may include, without limitation, details such as (i) a scope of work of the Services to be performed under such PSA which describes key activities and assumptions, (ii) the Product for which Samsung will perform such Services for Client, (iii) fees to be paid to SBL by Client for the Services, and (iv) any other deliverables.

 

1.60

“PSA Effective Date” means the effective date of any PSA entered into between the Parties.

 

1.61

“Purchase Order” is a commercial document issued by Client to SBL indicating, among other things, the quantity to be manufactured, the agreed prices for Product or Service, and the estimated delivery date to be later confirmed and fixed in accordance with Section 4.12.2(b).

 

1.62

“Quality Agreement” or “QAG” means the quality agreement entered into by the Parties that governs the responsibilities related to quality systems and quality requirements for the Product(s) Manufactured hereunder, including quality control, testing and release of such Product(s) at the Facility entered into by the Parties.

 

1.63

“Quarter” means each period of three (3) consecutive calendar months beginning on January 1, April 1, July 1, or October 1.

 

1.64

“Raw Materials” means those materials procured by SBL that are used in the Services. Raw Materials exclude the Client Materials.

 

1.65

“Regulatory Approval” means all approvals, licenses, registrations or authorizations thereof of any national, regional, state or local regulatory agency, department, bureau or other governmental entity in any jurisdiction where the Product is marketed or intended to be marketed, necessary for the manufacture and sale of the Product manufactured by SBL at the Facility.

 

1.66

“Regulatory Authority” means any national (e.g., the FDA), supra-national (e.g., the EMA), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, in any jurisdiction responsible for granting the Regulatory Approval.

 

1.67

“Reserved Capacity” means the capacity for Manufacturing the Product within SBL’s Facility reserved and dedicated to Client, the costs of which shall be calculated based on the Service Fees for Batches that were scheduled to be Manufactured using the Reserved Capacity.

 

1.68

“SBL Assignable Error” means: [***].

 

9


1.69

“SBL Invention” means any Invention which is not a Client Invention .

 

1.70

“Scope of Work” means the document generally forming part of a PSA, specifying in detail the scope and schedule of the Services and the Service Fees as mutually agreed upon by the Parties.

 

1.71

“Service” or “Services” means any service related to development and/or manufacturing for Client as specified in PSA and in accordane with the terms and conditions of this MSA.

 

1.72

“Service Fee” is the fee due and payable to SBL in consideration for SBL’s performance of Services and other obligations, but excluding the costs of Raw Materials, SBL handling fees, and other expense or cost reimbursements.

 

1.73

“Specification(s)” means for a given Product, the tests, references to any analytical procedures and acceptance criteria which are numerical limits, ranges or other criteria for tests described in order to establish a set of criteria for the Products, Client Materials, or Raw Materials, as the case may be, and which details are provided in documentation as reviewed and approved in writing by the Parties.

 

1.74

“Standard Operating Procedure(s)” or “SOP(s)” means the standard operating procedures established by and mutually agreed upon by both Parties regarding the Manufacturing Process.

 

1.75

“Tax” means all taxes, charges, customs duties, fees, levies, imposts, or withholding of whatever nature imposed by any law or regulations in any country in respect of the Services, importation or exportation of Raw Materials, Client Materials, Batches, and Product.

 

1.76

“Technology Transfer” means the activities by the Parties necessary for SBL to perform the Services as further described in the applicable PSA which may include, among other things: (i) transfer of the Background IP and Client Material from Client to SBL; (ii) implementation of the Manufacturing Process at the Facility; (iii) Manufacturing Process fit activities, and (iv) tests and studies.

 

1.77

“Term” means the duration for which this MSA stays in effect, which shall begin as of the Effective Date and will be in effect for as long as any PSA is in effect.

 

1.78

“Territory” means the United States, Europe, Africa, and Middle East and any other country set forth in the applicable PSA, or as that the parties otherwise agree in writing to add to this definition of Territory in an amendment to this MSA, but excluding any countries that are targeted by the comprehensive sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom, or the United States.

 

1.79

“Warehouse” means SBL’s warehouse for storage of the Product located at 300, Songdo bio-daero, Yeonsu-gu, Incheon, 21987, Republic of Korea.

 

10


SECTION 2 RELATED AGREEMENTS AND EXHIBITS

 

2.1

Product Specific Agreements. SBL will perform Services for Client as specified in PSAs and in accordance with the terms and conditions of this MSA. In the event of a conflict between any provision of this MSA and the PSA, this MSA shall control, except where the PSA specifically states otherwise and references this Section 2.1.

 

2.2

Quality Agreement (QAG). As required and within sixty (60) days of execution of this MSA, the Parties shall agree upon a Quality Agreement applying to such Services, and such Quality Agreement shall be incorporated into this MSA.

SECTION 3 MANAGEMENT OF SERVICE

 

3.1

General. SBL shall adequately staff the Facility with personnel with necessary expertise to perform its obligations under the MSA. Each Party will be responsible for its internal decision making process and for reasonably informing the other Party of decisions affecting the performance of the Service by SBL in a regular and timely manner. SBL shall complete the Services in accordance with the estimated timelines set forth in the applicable PSA. Client shall supply to SBL all information or materials that are reasonably required for SBL to perform the Services, and SBL shall not be responsible for any delays arising out of Client’s failure to do so. Client shall be responsible for additional costs and expenses arising out of such delay including, if applicable, the costs of Reserved Capacity.

 

3.2

Core Team and Joint Steering Committee.

 

  3.2.1

Core Team and Joint Steering Committee. The Parties shall establish the Core Team, which shall resolve any issues arising from the Services including but not limited to those relating to changes to the project assumptions and timelines, development activities, Specifications, or Manufacturing Process. The Parties shall also establish a Joint Steering Committee providing guidance to the Core Team and resolving any issues or disputes which in good-faith are not able to be resolved by the Core Team.

 

  3.2.2

Meetings and Decision Making. The Core Team and JSC shall meet on schedules and in manners that are acceptable to their respective members. Each Party may appoint temporary or permanent substitutes for any of such Party’s members on the Core Team or JSC and each Party may, in its reasonable discretion, invite non-member representatives of such Party to attend Core Team or JSC meetings. Each Party shall be responsible for its own expenses of traveling to and participating in any Core Team or JSC meeting. All decisions of the JSC and Core Team shall be made by the unanimous agreement of all of their members or their designated representatives, and shall be reflected in written meeting reports. Written reports of the JSC and Core Team shall be subject to approval by the authorized representatives of the Parties; provided, however, that the JSC and Core Team may not amend or waive any provision of the MSA or applicable PSA except by the terms of this MSA.

 

  3.2.3

Disputes. In the event that the Core Team, is unable, despite the good faith efforts of the members, to resolve a disputed issue that is within the purview of the Core Team for a period of ten (10) days, one Party shall formally request referral of the issue to the JSC. If the dispute still cannot be resolved within an additional thirty (30) days after referral to the JSC, the matter may be handled in accordance with Section 15.

 

 

11


3.3

Person in Plant. Client may request up to three (3) of its personnel to be on-site at the Facility to observe and consult with SBL during the performance of certain Services under this MSA including but not limited to Technology Transfer and process development activities, and such additional personnel in such numbers as deemed necessary shall be accommodated upon mutual agreement. Expenses associated with such on-site Client personnel shall be passed through to Client by SBL. While at the Facility, all such Client personnel shall have reasonable access to all areas as are relevant to SBL’s performance of the Service hereunder, provided that SBL may reasonably restrict Client personnel’s access to the Facility as it deems necessary, and all such Client personnel shall agree to and comply with confidentiality obligations to third parties, SBL policies and procedures related to safety, confidentiality, and cGMP, and all instructions of SBL employees at the Facility. Client shall remain responsible at all times for the compliance with the terms of this MSA and PSA by its employees and personnels.

 

3.4

Subcontract. SBL may subcontract any portion of the Services with prior approval from the Client. In the event SBL subcontracts any portion of the Services, SBL shall be primarily obligated to Client for ensuring that suchsubcontracted services are carried out as intended; provided however that, SBL shall not be responsible for any delay or breach caused by third parties or External Laboratories despite SBL’s exercise of reasonable care and efforts commonly used and customary in the industry. All costs associated with activities outsourced to third parties or External Laboratories will be passed through to Client with an additional ten percent (10%) handling fee.

 

3.5

Development and Manufacturing Site. Unless otherwise agreed by Client, all Services shall be performed by SBL at the Facility.

 

3.6

Manufacturing Documentation. SBL shall maintain Manufacturing Documentation to be true and accurate, and shall keep in strict confidence and shall not use for purposes other than providing or performing the Service or other obligations hereunder. SBL shall maintain all such Manufacturing Documentation for at least that period specified in the applicable QAG. Upon written request of Client and at mutually agreeable times, Client shall have the right to review Manufacturing Documentation at the Facility as further defined in the applicable QAG. Client may also request scanned or printed copies of such Manufacturing Documentation, but shall be responsible for reasonable costs associated therewith. SBL shall record and maintain such records, data, documentation and other information in the language as so required in the applicable QAG or as so required by a Regulatory Authority and in compliance with Applicable Law. SBL shall not provide Manufacturing Documentation provided pursuant to this MSA or any applicable PSA to any third party and shall protect such as the confidential information of Client. To the extent necessary, SBL may redact or withhold Manufacturing Documentation provided pursuant to this MSA or any applicable PSA to protect the confidential information of its other clients or third parties. The form and style of Batch documents, including, but not limited to, Batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of SBL. Notwithstanding anything to the contrary, SBL’s SOPs not specific to the Client’s Products may be provided to Client for on-site review if deemed necessary by both SBL and Client. Such SOPs cannot be removed from the SBL premises, copied, photographed or otherwise replicated.

 

12


SECTION 4 SERVICE DESCRIPTIONS

 

4.1

Technology Transfer. Client shall transfer to and grant SBL the license set forth below in Section 10 in respect of the Client Technology and Client Materials to SBL in accordance with the plan, timelines and quantities agreed upon by the Parties. In the event that Client agrees to utilize SBL’s data sharing portal for Technology Transfer, Client agrees that (a) in the event of any relevant change that affects a Client user’s authorization to use such portal, Client shall immediately notify SBL so that SBL may disable their usernames and remove / change passwords in order to secure the SBL Portal and (b) Client shall ensure that all of Client users have up-to-date antivirus software installed on the computer devices used to access such portal.

 

4.2

Engineering Batch. SBL makes no warranty that Engineering Batches will meet the Specifications or be successful. In the event there is a failure of an Engineering Batch, the parties will agree on whether another Engineering Batch is necessary or whether the next run should be a Process Validation Batch. If the parties do not agree, the matter will be escalated to the Joint Steering Committee.

 

4.3

Process Validation Batch. Prior to commencement of Process Validation Batches, SBL and Client shall agree to a validation plan identifying the validation requirements of the Manufacturing Process. The costs of process validation activities are excluded from the price of Process Validation Batches and shall be paid for by Client at the price set forth in the applicable PSA, subject to the Client’s prior approval on the scope and nature of such validation activities.

 

4.4

Facility Modification and Equipment. Client and SBL will agree on what equipment in the Facility is necessary to perform the Services, and if Client reasonably deems it necessary to procure additional equipment beyond that which is in the Facility as of the applicable PSA Effective Date, SBL shall procure such equipment at Client’s expense in accordance with Section 8.2.4 and be responsible during the Term for validation, installation, maintenance, commissioning, and decommissioning at SBL’s expense, unless otherwise agreed in writing by the Parties. Thereafter, if any additional equipment is necessary, such costs shall be dealt with by Section 5 of this MSA. Notwithstanding anything to the contrary in this MSA, the ownership of any and all such equipment shall remain at all times with SBL unless otherwise agreed in writing by both Parties.

 

4.5

Additional Work. Should the Parties mutually agree to any additional work to be added to the Scope of Work, the Service Fees for such additional work shall be based on SBL’s standard pricing at the time of adding such additional work, and depending on the nature of such additional work, the Parties shall execute a Decision Memo or an amendment to the PSA accordingly. In the event of changes to the Services based on Client’s request, Client shall bear all additional costs and expenses associated therewith.

 

13


4.6

Raw Materials.

 

  4.6.1

Management. SBL shall procure and maintain a reasonable quantity of Raw Materials, required for the Services in accordance with the MSA and any applicable PSA. On a per-Product basis, SBL shall prepare the categorization of the Raw Materials into (i) Critical Raw Materials, (ii) Customized or Dedicated Raw Materials, and (iii) Other Raw Materials, and send the categorization to Client for approval as soon as practicable after the Effective Date. Client shall approve the categorization in accordance with this MSA and any applicable PSA no later than one (1) month after the receipt of such a categorization from SBL. SBL shall not be liable for any delay soley resulting from Client’s failure to approve the categorization in a timely manner. The list of Raw Materials may be amended from time to time, subject to the Parties’ mutual agreement; provided however that, Client shall at all times be solely responsible for the costs of Raw Materials including those used in small scale runs during Technology Transfer, which is not included in the Service Fees. During Technology Transfer, the Core Team shall agree on estimates for Raw Materials anticipated to be consumed in the Manufacture of each Batch. Although SBL will make Commercially Reasonable Efforts to use no more than those amounts, SBL will not be responsible for Raw Materials used in excess of the agreed-upon estimate; provided, however, that SBL shall be responsible for any excess use, loss, spoilage, or waste of such Raw Materials to the extent caused by an SBL Assignable Error. Client and SBL shall mutually agree to strategies regarding Raw Material safety stock and sourcing from qualified vendors.

 

  4.6.2

Raw Material Specifications. Client and SBL shall agree on the Specifications of Raw Materials, including without limitation analytical methods, supplier information including supplier site information, and other information concerning the stability, storage, and safety thereof that are required for the Manufacturing hereunder, as further described in the applicable QAG.

 

  4.6.3

Testing and Evaluation. SBL or vendors qualified by SBL shall perform all testing and evaluation of Raw Materials as required by the Specifications for the Raw Materials and the cGMPs, as further described in the applicable QAG, if applicable.

 

  4.6.4

Storage. SBL shall secure sufficient and suitable storage for the Raw Materials; provided that such storage requirements shall be customary within SBL’s industry. SBL shall exercise reasonable care to preserve and protect Raw Materials from loss after receipt by SBL and prior to Manufacture and except for loss due to SBL Assignable Error, Client shall be responsible for the risk of loss of Raw Materials. At the end of each calendar year of the relevant PSA, Client shall be responsible for the loss of Raw Material to the extent purchased in reliance on a Purchase Order or Firm Period, and such Raw Material expires or becomes obsolete because Client fails to honor such a Purchase Order or Firm Period, and SBL cannot reasonably otherwise utilize such Raw Material.

 

  4.6.5

Handling Fee Related to Raw Material. Raw Materials will be charged on a pass-through basis to Client in accordance with Sections 8.1(ii) and 8.2.2, subject to any changes as agreed between the Parties.

 

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4.7

Client Materials.

 

  4.7.1

Management. Client shall provide, either by itself or through its third party supplier, to SBL free of charge, Client Materials in amounts reasonably necessary to carry out the Services as agreed by the Parties. SBL shall make Commercially Reasonable Efforts to import the Client Materials to the Republic of Korea in a timely manner, and Client shall provide reasonable assistance necessary for such a timely importation. Delivery conditions for the Client Materials shall be DDP Facility (INCOTERMS 2010) provided that the title and risk of loss to such Client Materials shall remain at all times with the Client and shall not transfer to SBL. During Technology Transfer, the Core Team shall agree on estimates for Client Material anticipated to be consumed in the Manufacture of each Batch. Although SBL will make Commercially Reasonable Efforts to use no more than those amounts, SBL will not be responsible for Client Materials used in excess of the agreed-upon estimate; provided, however, that SBL shall be responsible for any excessive use, loss, spoilage, or waste of such Client Materials to the extent caused by an SBL Assignable Error. Client and SBL shall mutually agree to strategies regarding Client Material safety stock and sourcing from qualified vendors.

 

  4.7.2

Client Material Specifications. Client shall provide SBL with the Specifications of the Client Materials, including without limitation analytical methods, supplier information, and other information concerning the stability, storage, and safety thereof that are required for the Manufacturing hereunder, as may be further described in the applicable QAG.

 

  4.7.3

Testing and Evaluation. SBL shall perform testing of the Client Materials in accordance with the applicable QAG and/or Client’s instruction prior to the performance of the Manufacturing hereunder, in order to determine whether such Client Materials meet the Specification described in the applicable QAG (if applicable). SBL shall inform Client of (a) any damage to the Client Materials received that is visually obvious (e.g., damaged or punctured containers and temperature monitoring results outside of predetermined Specifications) within ten (10) days after SBL’s receipt of the Client Materials and (b) any non-conformance of the Client Materials to Specification either: (i) within ninety (90) days after SBL’s receipt of the Client Materials or (ii) if release testing of Client Materials is not performed until it is needed for Manufacture, within ninety (90) days after such release testing is performed; or (iii) as other wise agreed between the Parties. If, prior to performing any Service on the Client Materials, SBL determines that such Client Materials are defective or damaged, SBL shall not perform the Service on such Client Materials and shall follow Client’s written instructions regarding disposal or return of such Client materials to Client, such disposal or return to be at Client’s discretion and cost.

 

  4.7.4

Storage. SBL shall secure sufficient and suitable storage for the Client Materials; provided that such storage requirements shall be customary within SBL’s industry. SBL shall exercise reasonable care to preserve and protect the Client Materials from loss after receipt by SBL and prior to Manufacture.

 

  4.7.5

Handling Fee Related to Client Material. Handling fees relating to the Client Material will be charged to Client in accordance with Sections 8.1(iii) and 8.2.3.

 

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4.8

Forecasts. For each Commercial Product, the Parties shall determine a mutually agreeable mechanism for forecasting of each Product, which shall be detailed in writing in each relevant PSA. For Clinical Product, the Parties shall agree upon the number and schedule of Batches to be Manufactured by SBL in the applicable PSA.

 

4.9

Purchase Orders. For each Clinical Product or Commercial Product, Client shall notify SBL in a binding form and procedure to be agreed upon in the applicable PSA requesting a specific amount of Product to be Manufactured in the Purchase Order. The Parties acknowledge that, with or without a Purchase Orders issued in advance, an invoice may be issued in accordance with this MSA, PSA, or applicable Decision Memo for Services, Raw Materials, handling fees and Equipment, and such invoices shall be processed and paid in accordance with Section 8.3.

 

4.10

Product Purchase Commitment. As further set forth in a PSA, during the Term, the Parties may agree that Client will purchase a minimum quantity of Batches of a certain Product in a given year (a “Product Purchase Commitment”).

 

4.11

Batch Failure during Manufacture

 

  4.11.1

If, during Manufacture of a Batch and prior to SBL’s batch release, the Core Team determines that all of a Batch is Non-Conforming Product (a “Batch Failure”), SBL shall take promptly re-Manufacture and deliver to Client a replacement Batch on a date to be mutually agreed by the Parties, which Service Fees and associated costs/fees (as set forth in Section 8.1 below) shall be invoiced and paid for by the Client. Client shall ensure that SBL has adequate Client Materials to Manufacture such Batches. The remedies contained in Section 4.11 of this MSA shall be the sole and exclusive remedies of Client regarding a Batch Failure and a Batch Failure shall not constitute a material breach of this MSA or a PSA unless SBL fails to provide the remedies contained in this Section 4.11.

 

  4.11.2

The Parties shall conduct a root cause analysis of the Batch Failure, which shall be done through SBL’s deviation process and which result will be reviewed and confirmed by the JSC. If either the Core Team does not agree on the Batch Failure root cause, or the JSC does not agree on the results of the Core Team’s Batch Failure root cause analysis, the Parties shall refer to an independent mutually agreed-on laboratory or firm with international repute, acting as a neutral arbiter, to conduct a root cause analysis of the Batch Failure. The costs of the independent laboratory will be shared by the Parties equally; provided, however, that the Party that is determined to be incorrect as to the Batch Failure will be responsible for those reasonable costs and must reimburse the correct Party for its share of the reasonable costs incurred. The decision of the independent laboratory must be in writing and will be binding on the Parties.

 

  4.11.3

In the event of Batch Failure due solely to SBL Assignable Error (other than due to gross negligence, fraud, or willful misconduct of SBL), SBL shall be responsible for the following costs: [***]

 

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  [***]. In the case of Batch Failure due solely to SBL Assignable Error due to gross negligence, fraud, or willful misconduct of SBL, in addition to the costs described in (1) – (4) above, SBL shall additionally be responsible for [***]. In the event of Batch Failure due to a reason not solely SBL Assignable Error, Client shall be responsible for the full costs described in (1) – (4) in the preceding sentence. Any such cost responsibility shall be refunded to Client or, at Client’s option, issued as a credit against future invoices by SBL.

 

  4.11.4

In the event that any of the foregoing procedures result in a Batch being delivered in a different year than the year in which the original Batch was ordered for delivery by Client, the Service Fee for such re-Manufactured Batch shall be the Service Fee set forth in the PSA.

 

4.12

Storage, Packaging and Delivery.

 

  4.12.1

Service Deliverables other than Products.Storage, packaging and delivery of the Service deliverables other than Products Manufactured and the Products Manufactured hereunder shall be made in accordance with the terms of this MSA, applicable PSA, applicable QAG and the Applicable Laws.

 

  4.12.2

Products.

 

  (a)

Release by SBL and Acceptance by Client.

 

  (i)

SBL shall perform all testing in accordance with the Specifications of the Product and release the Product in accordance with the terms of the applicable QAG. Upon such release, SBL shall deliver to Client the Batch Related Documents, including a Certificate of Analysis and Certificate of Compliance, in accordance with the applicable QAG;

 

  (ii)

Acceptance of Product. Client will complete the Acceptance Procedure and determine the acceptability of such Product in accordance with the applicable QAG and notify SBL of the result within thirty (30) days of Client’s receipt of the Batch Related Documents. Upon Client’s acceptance, SBL will have no liability for such Product. If Client does not reject such Product within the thirty (30) day period or within a shorter period as agreed by the Parties, the Product will be deemed to have been irrevocably accepted by Client and SBL will have no liability for such Product.

 

  (iii)

Non-Conforming. If, during the Acceptance Procedure, any Product is determined by Client as Non-Conforming Product, and SBL confirms such non-conformity, such non-conformity shall be treated as a Batch Failure, and the remedy set forth in Section 4.11 above shall apply to the Non-Conforming Product mutatis mutandis. Notwithstanding anything to the contrary, Client agrees to waive any and all rights to reject the Product after delivery in the event the Product has been altered, changed, or modified in any way for conjugation or otherwise. The remedies contained in this Section 4.12.2 shall be the sole and exclusive remedy of client in the event of Non-Conforming Product.

 

 

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  (b)

Delivery. Shipping conditions for the Product Manufactured hereunder shall be FCA Facility (INCOTERMS 2010), unless otherwise agreed to in the applicable PSA. The title to Product hereunder shall be transferred from SBL to Client when the Product is made available at the point of delivery consistent with FCA or the Incoterm set forth in the PSA. The Parties further agree as follows:

 

  (i)

After SBL’s release of the Product and prior to each pick-up by Client or Client’s designated carrier, SBL shall propose to Client a delivery schedule of the Product, in order for the Parties to agree on it in advance for each pick-up. SBL shall schedule Delivery with the carrier selected and paid for by Client;

 

  (ii)

SBL shall not deliver the Product until it has been instructed to by Client in accordance with the applicable QAG. Client shall confirm specific delivery instructions with SBL prior to SBL’s release. Upon SBL’s release of Product, SBL shall store the Manufactured Product as described in Section 4.12.2(c) and Client shall compensate SBL for storage costs for the Manufactured Product as set forth in the applicable PSA;

 

  (iii)

SBL shall provide Client with invoice, packing lists, supporting export documents as specified by Client by separate delivery and shipment documentation instructions, together with each shipment of the Product (or such other deliverables); and

 

  (iv)

In cooperation with Client and subject to the delivery schedule agreed by the Parties, SBL shall adhere to the first-expire-first-out (FEFO) principle in shipping all released Product.

 

  (c)

Storage, Packaging and Shipping Container.

 

  (i)

Pursuant to the terms of this MSA and any applicable PSA, SBL shall store the Products Manufactured hereunder.

 

  (ii)

SBL shall store, package, label and prepare shipment according to the Specifications for the Product Manufactured hereunder, the applicable QAG and the SOPs, and using storage and/or shipping containers determined in the applicable PSA.

 

 

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  (iii)

If Client does not direct SBL to prepare Manufactured Product to be picked up by Client or Client’s designated carrier with a pick-up date within thirty (30) days of Client’s receipt of the Batch Related Documents, SBL shall store the Product at the Warehouse, subject to the availability of space and storage conditions, and Client shall pay storage fees to SBL as set forth in Section 8.1 for the period of storage at the Warehouse until the actual delivery date; provided however that under no circumstances shall the period of storage in the Warehouse exceed sixty (60) days. SBL shall be responsible for risk of loss and damage to Manufactured Product in the event of SBL Assignable Error.

SECTION 5 CHANGES TO THE SPECIFICATIONS, ANALYTICAL METHODS, MANUFACTURING PROCESS, FACILITY OR EQUIPMENT

 

5.1

Approval for Change. Change shall be implemented only with mutual agreement between the Parties acting reasonably and in good faith and in accordance with the applicable QAG.

 

5.2

Changes Required by cGMP, Regulatory Authorities or Requested by Client. Except as otherwise expressly set forth to the contrary in the applicable QAG, in the event that cGMP, a Regulatory Authority, Applicable Law, or any other regulatory or legal authority requires, or Client requests, a Change, SBL shall accommodate such requirements or requests, subject to the following:

 

  (a)

Client shall promptly notify SBL in writing of the required and/or requested Change(s), and provide information necessary for SBL to evaluate the effect of such Change(s), and SBL shall promptly advise Client as to any (i) additional equipment required, modifications to the Facility or equipment, and/or additional equipment and the Facility qualification and validation requirements; (ii) Manufacturing Process development, transfer, scale-up, testing, qualification, or validation requirements; (iii) regulatory requirements pursuant to such Changes; (iv) changes to the Manufacturing scheduling and/or Product delivery schedule; and (v) other impacts on the Facility or SBL’s ability to manufacture products (including the Products) in the Facility, if any, which may result from such Change(s). The notification and formal approval procedure of such Changes shall be in accordance with the applicable QAG (i.e., change control procedures) (if applicable). The Parties shall meet in a timely manner to identify and discuss such Changes as appropriate;

 

  (b)

Prior to implementation of any such Change(s), SBL shall provide Client with an Implementation Plan and Budget. Following review and approval by Client of such Implementation Plan and Budget, subject to the Core Team’s approval and agreement followed by the Parties’ written agreement pursuant to Section 16.9 (if applicable), SBL shall commence implementation of such Change(s);

 

  (c)

During any such implementation, SBL shall provide Client with regular updates on the progress of implementation. Subject to any timeframe imposed by Applicable Law, SBL shall exercise Commercially Reasonable Efforts to implement the Change according to the Implementation Plan and Budget’s target completion date. SBL shall provide written notice to Client if SBL becomes aware of any cause which may create delay with the implementation of Changes. Following any such notice, both Parties shall discuss an amendment of Implementation Plan and Budget; and

 

 

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  (d)

Upon the approval of the Implementation Plan and Budget for Change(s), both Parties shall negotiate in good faith to determine the allocation of the costs incurred by SBL for the implementation of any such Change(s) between the Parties, in accordance with the following principles:

 

  (i)

the costs for the general Facility Changes required by cGMP, any Regulatory Authority, or any Applicable Laws related to the maintaining the Manufacturing Facility by SBL as set forth in Section 6.2, shall be borne by SBL, provided that where the Change relates exclusively or partially to the Manufacture of Product in which case the costs shall be borne by Client fully or proportionally, respectively;

 

  (ii)

the costs for the Changes other than (i) above, and requested by Client and required uniquely to the Manufacture of the Product and beneficial solely to Client shall be borne by Client; and

 

  (iii)

the costs for the Changes other than (i) and (ii) above shall be discussed in good faith by the Parties to achieve equitable allocation of costs.

SECTION 6 REGULATORY APPROVALS AND INSPECTIONS.

 

6.1

Regulatory Approvals. To the extent applicable, SBL shall provide reasonable assistance and cooperation in order for Client to obtain and maintain the Regulatory Approvals. The costs and fees associated with such assistance and cooperation, to the extent not detailed in the MSA or PSA shall be borne by Client. As specified in the applicable PSA, the Parties shall discuss and agree on which Regulatory Approvals are to be obtained.

 

6.2

Regulatory Approvals for the Facility. To the extent applicable, SBL shall obtain and maintain all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity (other than the Regulatory Approvals, which will be obtained or maintained by Client) that are required to Manufacture the Product at the Facility and perform the Services.

 

6.3

Regulatory Support Activities. Any regulatory support activities (including Pre-Approval Inspections) required and agreed to by Client to support Regulatory Approval of the Product from the Facility shall be performed and supported by SBL as reasonably requested by Client. All such regulatory support activities are excluded from the price of Process Validation Batches, shall be approved by the Client in advance, and shall be paid for by the Client at the price set out in the applicable PSA. SBL shall notify Client according to the applicable QAG provisions of any contacts or inquiries by the Regulatory Authorities, including inspections, Pre-Approval Inspections, sample requests, and written correspondence and its result, related to the Product.

 

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SECTION 7 QUALITY COMPLIANCE

 

7.1

Quality Agreement. Both Parties shall adhere to the provisions of the applicable QAG and the Parties agree that all elements of quality assurance, quality control and the like shall be governed by the terms and conditions of the applicable QAG. In the event of a conflict between a Quality Agreement and either any provision of this MSA or any PSA, the MSA or PSA shall control except with respect to matters directly and specifically related to Product quality or regulatory requirements, in which case, the Quality Agreement will control.

 

7.2

Records & Audit.

 

  7.2.1

Audit by Client. Upon Client’s request, but no more than once per year, SBL shall accept a formal audit of the Facility and, if necessary, the Warehouse, by Client and allow Client to inspect the Facility and, if necessary, the Warehouse, and Manufacture of the Product during provision of the Services solely to ascertain compliance by SBL with the terms of this MSA or any applicable PSA; provided, however that in the event Client uses a designee, SBL must provide prior written consent. SBL shall be reimbursed for its reasonable costs for additional audits, other than for-cause audits, beyond the audit described in the first sentence of this Section 7.2.1. SBL will make Commercially Reasonable Efforts to require vendors or subcontractor to accept an audit of their facilities by Client upon similar notice as described in Section 7.2.2 below.

 

  7.2.2

Audit Notice. Client shall provide SBL with a written notice at least two (2) months prior to the initiation of the audit of the Facility and, if necessary the Warehouse, set forth in Section 7.2.1, which shall be conducted on a mutually agreeable date and time, and with a mutually agreed duration, agenda, and visitor list. Notwithstanding the foregoing, if the audit is required for cause (i) due to safety reasons that necessitate immediate audit of or visit to the Facility or (ii) Client asserts that a substantial violation of the Quality Agreement has occurred which cannot be resolved through the normal Core Team / JSC process, the foregoing sentence shall not apply and Client may conduct such audit or visit by providing SBL with a prior notice by email. Access to SBL’s facilities shall be coordinated with SBL so as to minimize disruption to SBL’s ability to perform services for its other clients. Client representatives must comply with all of SBL’s cGMP, confidentiality and security procedures and protocols during such observations, consultations, and inspections. SBL shall at all times cooperate and provide all the necessary documents reasonably required by Client during such audit; provided that, to the extent necessary, SBL may redact or withhold documents to protect the confidential information of its other clients. Client shall be solely responsible for any costs and liability caused by Client’s or its representatives’ failure to comply with SBL’s security, safety or confidentiality procedures.

SECTION 8 CONSIDERATION AND PAYMENT TERMS

 

8.1

Consideration. In consideration for SBL’s performance of the Service and other obligations undertaken by SBL pursuant to a PSA, Client shall pay SBL (i) the Service Fees as set forth in the applicable PSA; (ii) a handling surcharge of a certain percentage or certain amount to be set forth in the applicable PSA of the costs of Raw Materials paid by SBL (including but not limited to applicable Taxes); (iii) a handling surcharge of a certain percentage or certain amount to be set forth in the applicable PSA related to the Client Materials (which shall be based on the actual costs of such materials as supported by reasonable documentary evidence as opposed to the market value thereof and which include Taxes); and (iv) storage fees as set forth in the relevant PSA.

 

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8.2

Invoices.

 

  8.2.1

Service Fee of the Project Stages and Batches. The Service Fees for any Batches shall be invoiced upon SBL’s release of a Batch of Product. All other Service Fees shall be invoiced after the completion of each applicable project stage in accordance with the PSA. SBL’s invoices pursuant to this MSA shall be electronic, unless otherwise agreed by the Parties.

 

  8.2.2

Raw Materials. With respect to the Raw Materials, SBL shall submit invoices to Client for the applicable Raw Materials cost (including any safety stock) as set forth according to Section 8.1 as follows. SBL shall submit an invoice to Client (i) for the cost of Critital Raw Materials, and Customized or Dedicated Raw Materials upon receipt of the invoice from vendors/suppliers; and (ii) for the cost of Other Raw Materials used upon SBL’s completion of such project stage or upon SBL’s release of a Batch of Product as applicable. In each case, for all Raw Materials, SBL shall prepare a billing summary detailing the Raw Materials used and send the same to Client in accordance with Section 8.2.5. Within 2 weeks of receiving the billing summary for Raw Materials from SBL, Client shall either (1) accept and issue a purchase order for the Raw Material in accordance with the billing summary or (2) reject the billing summary based on reasonable grounds, in which case SBL shall promptly re-issue the billing summary. Client’s failure to accept or reject a billing summary within the two (2) week period shall be deemed an acceptance of the billing summary, and SBL will issue the corresponding invoice with or without a previously issued purchase order from Client.

 

  8.2.3

Client Materials. With respect to the Client Materials, which shall be supplied by Client to SBL at no cost during SBL’s performance of the Service, SBL shall submit an invoice to Client for reasonable and mutual agreed handling fees as set forth in the PSA upon SBL’s completion of such project stage of the Service or SBL’s release of a Batch of Product, as applicable.

 

  8.2.4

Equipment. With respect to Equipment, SBL shall submit an invoice to Client subject to Section 4.4 upon receipt of the relevant invoice from equipment vendor/supplier.

 

  8.2.5

Diclosure of Original Invoices. For any Raw Materials or Equipment purchased from third party vendors, Client agrees and acknowledges that SBL shall be under no obligation to disclose the original invoice or any confidential information therein from the vendors due to its confidentiality obligation with such vendors, and that not furnishing such documents shall not constitute a valid ground for rejecting SBL’s billing summary or invoice. Client may, however, request a third party audit at Client’s expense upon presenting reasonably objective and reliable market date or price quotation justifying such an audit, and confirm through the auditor the sole issue of whether there is any discrepancy or inaccuracy between the vendor’s invoices and SBL’s billing summary or invoice (without the auditor disclosing any confidential information of the vendor to Client). Should a discrepancy or inaccuracy be found through such an audit, SBL shall be responsible for the costs of such an audit and promptly re-issue the invoice with the correct amount and/or reimburse the amount paid in excess of the correct amount.

 

 

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8.3

Payment.

 

  8.3.1

Mode of Payment; Foreign Exchange. All payments to SBL due under the MSA or any applicable PSA shall be made in US$ within [***] days from the receipt of SBL’s invoice in US$ by means of telegraphic transfer to the account with the bank designated by SBL in the applicable invoice without any deduction, deferment, set-off or lien. For the purpose of computing payment amounts incurred by SBL in a currency other than US$, such currency shall be converted into US$ using the Standard Rate published by the Bank of Korea at the opening of business on such invoice date.

 

  8.3.2

Taxes. All prices and charges are exclusive of any Taxes, which shall be paid by Client. For the avoidance of doubt, the foregoing shall not include any taxes imposed on the income or profit of SBL levied on any payment to be made by Client to SBL, each of which shall be solely borne by SBL. Client shall pay or reimburse SBL for all Taxes in connection with the purchase, sale, storage, importation or exportation of any Raw Materials, Client Materials, Batches, or Product or the provision of Services, except to the extent such Taxes are recoverable by or refundable to SBL. SBL agrees to use Commercially Reasonable Efforts to assist Client in claiming exemption under double taxation or similar agreement or treaty from time to time in force to obtain a refund of any customs duties, value added taxes, and other taxes payable by SBL.

 

  8.3.3

Price Adjustments. The Service Fees as set forth in the applicable PSA, shall be adjusted annually on January 1 of each year during the Term, effective immediately, by the percentage change in the consumer price index as published by the Bank of Korea for the immediately preceding twelve (12) months, provided that any given year’s adjustment shall be no more than [***]. The relevant date for price adjustment under this Section shall be the issue date of SBL’s invoice.

 

  8.3.4

Default Interest. Any amount that is not paid by a Party to the other when due under the MSA or any PSA shall bear default interest at the rate of [***] per annum on a pro rata basis from the day following the due date until paid in full. In the event there is an amount which is invoiced by SBL but not paid by Client for more than six (6) months after the due date, such event shall be considered a material breach of the relevant PSA.

SECTION 9 CONFIDENTIALITY

 

9.1

Confidential Information. Both Parties agree not to use the other Party’s Confidential Information except in accordance with the terms of this MSA, the QA and the applicable PSA and to maintain the Disclosing Party’s Confidential Information in confidence and not to disclose the Disclosing Party’s Confidential Information, in whole or in part, to any third party, and not use the Disclosing Party’s Confidential Information for any purpose other than performing the obligations under the MSA or applicable PSA. The Receiving Party recognizes the proprietary nature of the Disclosing Party’s Confidential Information and agrees that no right, title, ownership, license, or

 

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  interest of any character in the Disclosing Party’s Confidential Information other than as specifically granted herein, is conveyed or transferred to the Receiving Party. Each Party shall guard such Confidential Information, including any trade secret information, using the same degree of care as it normally uses to guard its own confidential, proprietary or trade secret information of like importance, but in any event no less than reasonable care. The Receiving Party shall limit disclosure of the Disclosing Party’s Confidential Information to its and its Affiliates’ directors, officers, employees, consultants and agents (“Representatives”) only on a need-to-know basis, provided that, the Receiving Party shall undertake procedures such that each of its Representatives to whom the Disclosing Party’s Confidential Information is disclosed understands (i) the confidential nature of the Disclosing Party’s Confidential Information and (ii) that he or she is under obligations at least as protective of Client’s Confidential Information as those contained herein, including to not use or disclose the Disclosing Party’s Confidential Information. SBL shall maintain accurate records of each of SBL’s Representatives who have accessed Client’s Confidential Information contained within SBL’s cGMP document management systems, provided that such systems are capable of maintaining such records, and such records will be provided to Client upon request, including as part of an audit scheduled pursuant to Section 7.2 above. To SBL’s knowledge, its current cGMP document management systems are capable of maintaining such records.

 

9.2

Exceptions. Notwithstanding Section 9.1 above, Confidential Information shall not include the portion of information, which as evidenced by written records: (a) was at the time of disclosure by the Disclosing Party hereunder publicly known or available; (b) after disclosure by the Disclosing Party hereunder, became publicly known or available by publication or otherwise, other than by an unauthorized act or omission by the Receiving Party; (c) was in the possession of the Receiving Party without confidentiality restriction at the time of the disclosure by the Disclosing Party hereunder; (d) was lawfully received from any third party having the lawful right to make such disclosure, without obligation of confidentiality; or (e) was independently developed by the Receiving Party’s directors, officers or employees without reference to the Confidential Information, as demonstrated by records contemporaneous with such development.

 

9.3

Authorized Disclosures. Disclosure is permitted in the event that (a) the Disclosing Party’s Confidential Information is reasonably required to obtain or maintain any Regulatory Approvals for the Products in any or all jurisdictions or (b) the Disclosing Party needs to disclose such Confidential Information to comply with Applicable Law; provided that such Receiving Party shall limit disclosure of the Disclosing Party’s Confidential Information to that which is necessary for compliance and to otherwise maintain the confidentiality of the Confidential Information.

 

9.4

Survival of confidential obligations. The confidential obligations of the Receiving Party shall survive for a period of ten (10) years from the expiration or termination of this MSA except with respect to Confidential Information which consititutes trade secrets, for which the obligations will continue for so long as such information remains a trade secret under Applicable Law.

 

9.5

Return of the Confidential Information. All written, printed or other tangible Confidential Information of the Disclosing Party disclosed under the MSA, and all copies thereof shall be returned to the Disclosing Party (or destroyed at the Disclosing Party’s request) by the Receiving Party within thirty (30) days from the written request by the Disclosing Party. All Confidential Information disclosed electronically shall be completely deleted and destroyed by the Receiving Party within

 

24


  thirty (30) days from the written request by the Disclosing Party. Notwithstanding the foregoing, digital backup files automatically generated by the Receiving Party’s customary electronic data processing system may be retained and properly stored as confidential files for the sole purpose of backup and will be deleted in accordance with the Receiving Party’s retention policy.

SECTION 10 OWNERSHIP OF MATERIALS AND INTELLECTUAL PROPERTY

 

10.1

Background Intellectual Property. It is acknowledged that each Party owns or controls Background IP and nothing in this MSA shall affect such rights in Background IP. Client hereby grants SBL a non-transferrable, royalty-free, irrevocable, sublicensable (to the extent necessary to conduct the Services) and fully-paid-up right and license to use Client’s Confidential Information and Intellectual Property during the Term for the sole purposes of performing the Services in accordance with the MSA. Except as otherwise provided herein, the Parties shall not acquire any right, title, or interest in any Background IP of the other Party.

 

10.2

Inventions.

 

  10.2.1

Client Invention. SBL shall notify Client of any Client Invention(s) immediately after such conception and reduction to practice, and shall take all reasonable measures so that Client would have the sole and exclusive ownership of any and all Client Invention. Client may use any Client Invention for any purpose, including filing patent application and SBL shall provide reasonable cooperation to Client at the expense of Client as to all reasonable out-of pocket expenses incurred by SBL.

 

  10.2.2

SBL Invention. SBL Invention shall be the property of SBL and shall not be deemed to be Client Invention or joint invention for the purposes of the MSA: provided, however, that SBL grants to Client a geographically unrestricted, irrevocable, non-transferable, non-sublicensable, royalty-free and fully-paid-up right and license under such SBL Invention to make, use, sell, offer to sell, export and import and otherwise exploit the Product, without an obligation of accounting to SBL, to the extent such SBL Invention is incorporated into the Product or its manufacture.

SECTION 11 WARRANTIES.

 

11.1

The Parties General Warranties. Each Party warrants and represents that: (i) it has the corporate power and authority to enter into this MSA and has taken all necessary action on its part required to authorize the execution, delivery and performance of this Agreement; (ii) it is aware of no legal, contractual or other restriction, limitation or condition that might adversely affect its ability to enter into this MSA and perform its obligations hereunder; (iii) it is duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is incorporated; (iv) this MSA (a) has been duly executed and delivered by a duly authorized representative of it, and (b) is the legal, valid and binding obligation of it, enforceable against it in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or other similar laws now or hereafter in effect relating to or affecting creditors’ rights generally; and (v) the execution, delivery and performance of this Agreement by it does not and will not (a) violate any Applicable Laws applicable to it, or (b) violate or conflict with any provision of its Articles of Incorporation or By-laws or other organizational documents.

 

25


11.2

Client’s Warranties. Client represents and warrants to SBL that as of the Effective Date of the MSA and during the Term: (a) the Product shall comply with all Applicable Laws and that, during the Term Client will comply with Applicable Law in relation to such Product and shall perform all obligations and take other necessary actions to be in compliance with such requirements, Applicable Laws, rules and regulations, including applicable cGMPs; (b) Client will comply with all Applicable Laws, and that it will keep SBL informed of any information known to Client which would affect SBL’s provision of the Service hereunder; (c) all Client Technology, Client Materials provided to SBL by or on behalf of Client will be suitable for the Manufacture of the Product; and (d) to the best of its knowledge, SBL’s use of the Client Materials, Manufacturing Process, and Client Technology related to the Service in accordance with the terms of this MSA will not infringe any third party’s Intellectual Property rights.

 

11.3

SBLs Warranties. SBL represents and warrants that:

 

  11.3.1

As of the Effective Date and during the Term, (i) SBL is the lawful owner, lessee, operator, or licensee of the Facility, equipment, machinery, as well as permissions required, to enable SBL to perform its obligations under this MSA, and (ii) to the best of SBL’s knowledge, none of the SBL Inventions or SBL Background IP infringes any third party Intellectual Property Right.

 

  11.3.2

All Product Batches, at the time of delivery to Client’s designated carrier, shall (a) be Manufactured, packaged, handled and stored in compliance with the requirements of cGMPs (except for Engineering Batches unless otherwise agreed) and all Applicable Laws; (b) comply with the Standard Operating Procedures; and (c) be transferred free and clear of any liens, claims or encumbrances of any kind.

 

11.4

No Other Warranties. THE REPRESENTATIONS AND WARRANTIES CONTAINED IN THIS SECTION ARE EXPRESSLY IN LIEU OF AND EXCLUDE, AND THE PARTIES HEREBY EXPRESSLY DISCLAIM AND NEGATE, TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAWS, ALL OTHER REPRESENTATIONS AND WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED (ARISING BY OPERATION OF LAW OR OTHERWISE), INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, EVEN IF THAT PURPOSE IS KNOWN.

SECTION 12 INDEMNIFICATION

 

12.1

Indemnification by SBL. SBL shall indemnify and hold harmless Client, its Affiliates, and their officers, directors, employees or agents from and against any Damages arising or resulting from any third party (which shall exclude Client Affiliates) claims to the extent such Damages are relating to, arising out of, in connection with, or resulting from claims, demands, or actions based upon SBL Assignable Error, except to the extent that such Damages are caused by the causes as set forth in Section 12.2 for which Client is obliged to indemnify.

 

12.2

Indemnification by Client. Client shall indemnify and hold harmless SBL, its Affiliates, and their officers, directors, employees or agents from and against any Damages arising or resulting from any third party (which shall exclude SBL Affiliates) claims to the extent such Damages are relating to, arising out of, in connection with, or resulting from claims, demands or actions based upon (i) gross

 

26


  negligence or willful misconduct of Client or its officers, directors, employees or agents, (ii) any product liability claims related to manufacture, sale, or distribution of Products that have been accepted by Client under Section 4.12.2, or (iii) any claim that any SBL activity undertaken for the purposes of or in relation to the Services pursuant to the MSA or any PSA (including but not limited to use of the Client Materials, Manufacturing Process and Client Technology, as well as any tests, studies, experiments, or other activities undertaken at the request of, or with the consent of, Client) infringes any third party’s Intellectual Property rights; in each case (i), (ii) and (iii) except to the extent that such Damages are caused by the causes as set forth in Section 12.1 for which SBL is obliged to indemnify.

 

12.3

Indemnification Procedure. The foregoing indemnification by SBL or Client shall be conditioned, if and to the extent Damages are based on or related to a third party claim, upon a Party who intends to claim indemnification under Sections 12.1 and 12.2 (the “Indemnified Party”) (i) providing written notice to the other Party (“Indemnifying Party”) within twenty (20) days after the Indemnified Party have been given written notice of such third party claim, provided that absence or delay of such prior written notice will not relieve the Indemnifying Party of its obligation to indemnify except to the extent such absence or delay materially prejudices the Indemnifying Party’s ability to defend the third party claim; (ii) permitting the Indemnifying Party, upon timely notice by the Indemnified Party, the opportunity to assume full responsibility (at the Indemnifying Party’s cost and expense) for the investigation and defense of any such claim with counsel reasonably satisfactory to the Indemnified Party, provided, however, that the Indemnifying Party shall keep the Indemnified Party informed as to the progress of the defense of any claim and that the Indemnified Party shall cooperate in such defense and shall make available all records, materials and witness reasonably requested by the Indemnifying Party in connection therewith; and (iii) not settling or compromising any such claim without the Indemnifying Party’s prior written consent, with such consent not to be unreasonably denied, withheld or conditioned.

SECTION 13 DISCLAIMER OF CONSEQUENTIAL DAMAGES; LIMITATION OF LIABILITY

 

13.1

Disclaimer of Consequential Damages. EXCEPT WITH RESPECT TO (I) BREACHES OF SECTIONS 9 AND 10; (II) INSTANCES OF GROSS NEGLIGENCE OR WILLFUL MISCONDUCT; AND/OR (III) THIRD PARTY DEATH OR BODILY INJURY CAUSED BY SBL TO CLIENT EMPLOYEES OR CONTRACTORS WHO MAY VISIT SBL SITES, NEITHER PARTY WILL BE LIABLE UNDER THIS AGREEMENT FOR ANY SPECIAL, PUNITIVE, CONSEQUENTIAL, INCIDENTAL OR OTHER INDIRECT DAMAGES OF ANY TYPE OR NATURE, WHETHER BASED IN CONTRACT, TORT, STRICT LIABILITY, NEGLIGENCE OR OTHERWISE, INCLUDING LOSS OF PROFITS OR REVENUES.

 

13.2

Limitation of Liability. Except with respect to Damages or allowable indirect damages arising under or in connection with a PSA arising out of (i) breaches of Sections 9 and 10; (ii) instances of gross negligence or willful misconduct (which shall not include Materials Claims, defined below); (iii) damage or destruction of Critical Raw Materials due to the gross negligence or willful misconduct of SBL (including pursuant to Section 4.11.3 above) (such claims arising under this 13.2(iii) shall be referred to herein as (“Materials Claims”); and/or (iv) third party death or bodily injury caused by SBL to Client employees or contractors who may visit SBL sites, Client agrees that

 

27


  SBL’s aggregate total liability to Client in respect of any Damages or allowable indirect damages arising under or in connection with a PSA (whether in contract, tort, negligence, under indemnity or otherwise however arising) (collectively, “Ordinary Claims”) in a given calendar year shall be capped at an amount equal to [***] the amounts payable by Client to SBL in such calendar year under such PSA. Client agrees that SBL’s aggregate total liability to Client in respect of any Materials Claims arising in a given calendar year shall be capped at an amount equal to [***] of the amounts payable by Client to SBL in such calendar year under such PSA. SBL’s aggregate total liability to Client in any given calendar year for Materials Claims and Ordinary Claims combined shall not exceed [***] of the amounts payable by Client to SBL in such calendar year under such PSA.

SECTION 14 TERM AND TERMINATION OF AGREEMENT

 

14.1

Term. This MSA will become effective as of the Effective Date and will be in effect for as long as a PSA is in effect; provided that if the only currently effective PSA has expired and such expiry causes an unintentional expiration of this MSA, the term of the MSA shall be extended upon mutual agreement of the Parties. Each PSA will have its own initial term as stated therein and shall renew upon mutual agreement.

 

14.2

Termination. This MSA or a PSA may be earlier terminated as set forth in this Section 14.2.

 

  14.2.1

By Client. Client may terminate a PSA and/or this MSA without cause on thirty (30) days prior written notice to SBL.

 

  14.2.2

Material Breach. A Party may terminate any PSA for a material breach by the other Party; provided, however, that the non-breaching Party shall give the breaching Party written notice of such breach and if the breaching Party fails to commence Commercially Reasonable Efforts to cure that breach within thirty (30) days after receipt of such written notice, then the non-breaching Party may terminate this Agreement on thirty (30) days written notice after expiration of such thirty (30) day period. This MSA shall terminate if all effective PSAs are terminated.

 

  14.2.3

Insolvency. This MSA may be terminated by either Party upon written notice at any time during the MSA if the other Party: (a) files in any court pursuant to any statute a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of such Party, or of its assets; (b) proposes a written agreement of composition for extension of its debts; (c) is served with an involuntary petition against it, filed in any insolvency proceeding which is admitted in the court; or (d) makes an assignment for the benefit of its creditors. The Party affected shall immediately notify the other Party in writing of the occurrence of any of the foregoing events.

 

  14.2.4

Force Majeure. Either Party may terminate a PSA if a Party is unable to perform its obligations pursuant to a PSA in the event of a Force Majeure Event in accordance with Section 16.3.

 

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  14.2.5

Other Specified Events. The Parties may additionally terminate a PSA as set forth in the applicable PSA .

 

14.3

Effect of Expiration or Termination.

 

  14.3.1

Payment of Amounts Due. Expiration or termination of the MSA or PSA for any reason shall not exempt either Party from paying to the other Party any amounts owing at the time of such expiration or termination.

 

  14.3.2

Survival. Any termination or expiration of this MSA shall not affect any outstanding obligations due hereunder prior to such termination or expiration, nor shall it prejudice any other remedies that the parties may have under this MSA. For greater certainty, except as otherwise expressly provided, termination or expiration of this MSA, irrespective of the cause, shall not affect any rights or obligations which, from the context thereof, are intended to survive termination or expiration of this MSA, including but not limited to Sections 8, 9, 10, 11, 12, 13, 14, 15, and 16.

 

14.3.3

Effect of Termination. Upon termination of a PSA for any reason, SBL shall promptly cease and refrain from the Services described in any applicable PSA (including the Manufacturing and supplying the Product) for Client unless otherwise provided in this Section 14.3.3. SBL shall take all reasonable steps to mitigate the out-of-pocket expenses incurred in connection therewith. In particular, SBL shall use its best efforts to: (a) immediately cancel, to the greatest extent possible, any third party obligations; (b) promptly inform Client of any irrevocable commitments made in connection with any pending purchase order prior to termination; (c) promptly inform Client of the cost of any remaining unused, unreturnable Raw Materials ordered pursuant to any pending purchase order, and either deliver such materials to Client (or its designee) or properly dispose of them, as instructed by Client; and (d) perform only those services and activities mutually agreed upon by Client and SBL as being necessary or advisable in connection with the close-out of the PSA. Both Parties shall pursue decommissioning activities as set forth hereunder:

 

  (a)

Settlement of Payment. SBL shall be compensated no later than sixty (60) days after a termination for:

 

  (i)

all Service Fees incurred up to the date of termination including the Service Fees for completing the Manufacture of Product-in-process, subject however to Section 14.3.3(b) below;

  (ii)

all costs incurred through the date of termination, including the costs of procuring Raw Materials used or purchased for use in connection with Services; and

  (iii)

any unreimbursed procurement fee of additional equipment that SBL has purchased on behalf of Client pursuant to Section 4.4.

 

  (b)

Delivery. Unless any major issue related to quality that reasonably would have a materially adverse impact on any Product Manufactured by SBL exists, upon consent of Client, SBL shall continue manufacturing Product-in-process as of the date of termination and deliver the fully manufactured Product to Client in accordance with

 

29


  the schedule then agreed upon by the Parties. As soon as practically possible after the termination and provided that Client has paid the invoice for such Raw Materials, SBL shall deliver to Client and Client shall accept (1) any Raw Material purchased for use in connection with Services, (2) any Client Material then in possession of SBL; provided however that the Parties may mutually agree instead to destroy or discard such Raw Material or Client Material, in which case SBL shall promptly destroy or dispose of the same without making any further use of such materials. Any costs incurred in connection with such a delivery or destruction, as the case may be, shall be borne by the Party responsible for termination in accordance with (c) and (d) below; provided that, for all other cases, the Parties shall negotiate in good faith the allocation of all such costs and expenses.

 

  (c)

Termination by SBL pursuant to Clause 14.2.2. In the event of termination by SBL pursuant to Clauses 14.2.2, the outstanding binding obligations to purchase Product as of the date of termination shall survive termination of such PSA, including but not limited to a Firm Period, Binding Forecast, Purchase Order, and Product Purchase Commitment, and the Client shall be responsible for the costs incurred in connection with delivery or disposal of Raw Materials, Client Material, or equipment during decommissioning activities.

 

  (d)

Termination by Client pursuant to Clause 14.1. In the event of termination of a PSA by Client pursuant to Clause 14.2.1, the Parties shall agree in such PSA what fee shall be due by Client to SBL.

 

  (e)

Termination by Client pursuant to Clauses 14.2.2 or 14.2.3. In the event of termination by Client pursuant to Clauses 14.2.2 or Clause 14.2.3, Client shall be released from any outstanding binding obligations to purchase Product as of the date of termination including but not limited to any obligation pursuant to a Firm Period, Binding Forecast, Purchase Order, and Product Purchase Commitment, except the decommissioning activities set forth in this Section 14.3.3 of the MSA which shall be binding on both Parties.

 

  (f)

Termination by either Party based on Clause 14.2.4. Both Parties shall negotiate in good faith and based on industry standards for the handling and delivery of the fully Manufactured Product, Product-in-process, Client Materials, and Raw Materials and the allocation of costs and expenses between the Parties.

 

  14.3.4

Effect of Expiration. Upon expiration of a PSA at the end of the Term or any renewed Term, SBL shall cease and refrain from the Services described in any applicable PSA (including the Manufacturing and supplying the Product), and Section 14.3.3 above shall apply mutatis mutandis, and both Parties shall negotiate in good faith the allocation of related costs and expenses for such decommissioning activities.

 

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SECTION 15 ARBITRATION

 

15.1

Informal Discussions. Except as otherwise provided herein, in the event of any controversy or claim arising out of or relating to this MSA, or the rights or obligations of the Parties hereunder, the Parties shall first try to settle their differences amicably between themselves through the Core Team and then JSC level. Thereafter, either Party may initiate informal dispute resolution on the Executive level by sending written notice of the dispute to the other Party, and within fifteen (15) days after such notice appropriate Executives of the Parties shall attempt resolution by good faith negotiations. If such representatives are unable to resolve promptly such disputed matter within the said fifteen (15) days, either Party may refer the matter by written notice to the Chief Executive Officer of the other Party, or his/her designee, and the Chief Executive Officer of such Party, for discussion and resolution. If such individuals or their designees are unable to resolve such dispute within thirty (30) days of such written notice, either Party may initiate arbitration proceedings in accordance with the provisions of this Article 15.

 

15.2

Arbitration. If the Parties do not fully settle a dispute pursuant to Section 15.1, and a Party wishes to pursue the matter, each such dispute, controversy or claim shall be finally resolved by binding arbitration in accordance with the Commercial Arbitration Rules of the International Chamber of Commerce (“ICC”), and judgment on the arbitration award may be entered in any court having jurisdiction thereof to enforce the arbitration award. The arbitration shall be conducted by a panel of three persons experienced in the pharmaceutical business, and within thirty (30) days after initiation of arbitration, each Party shall select one person to act as arbitrator and the two Party-selected arbitrators shall select a third arbitrator within thirty (30) days of their appointment. If the arbitrators selected by the Parties are unable or fail to agree upon the third arbitrator, the third arbitrator shall be appointed by the ICC. The place of arbitration shall be New York, New York, United States and all proceedings and communications shall be in English. Either Party may apply to the arbitrators for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved. Either Party also may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of that Party pending the arbitration award. The arbitrators shall have no authority to award punitive or any other type of damages not measured by a Party’s direct compensatory damages, and in all cases, any decision or determination by the arbitrators shall comply with Article 14, as applicable. The Parties agree that, in the event of a good faith dispute over the nature or quality of performance under this Agreement, neither Party may terminate this Agreement until final resolution of the dispute through arbitration or other judicial determination.

 

15.3

Costs and Fees. Each Party shall bear its own attorneys’ fees, costs, and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the arbitrators. Absent the filing of an application to correct or vacate the arbitration award as permitted by Applicable Law, each Party shall fully perform and satisfy the arbitration award within fifteen (15) days after the service of the award on such Party.

SECTION 16 MISCELLANEOUS

 

16.1

Notices. Any notice required or permitted under the MSA shall be in writing with duly authorized signature and made to the following addresses:

 

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If to Client:

Greenlight Biosciences, Inc.

200 Boston Avenue, Suite 1000

Medford, MA 02155

Attention: Legal Affairs

If to SBL:

Samsung Biologics Co., Ltd.

300, Songdo bio-daero, Yeonsu-gu

Incheon 21987, South Korea

Attention: SBL Legal Team

Either Party may change its designated address by notice to the other Party in the manner provided in this Section 16.1.

Any notice shall be deemed to have been delivered on the date of delivery if delivered personally, or on the third day after being delivered by a national or internationally recognized overnight or two-day courier service, or on the fifth day of posting if sent by registered or certified mail with return receipt requested and postage prepaid.

 

16.2

Governing Law. This MSA shall be construed and interpreted in accordance with the laws of State of New York, United States and all rights and remedies shall be governed by such laws without regard to principles of conflicts of law. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to the transactions contemplated by the MSA.

 

16.3

Effect of Force Majeure Event. Except as set forth in this Section 16.3,the Affected Party shall be liable to the other Party for failure or delay to perform its obligation under the MSA or any applicable PSA when such failure or delay is due to Force Majeure Event.

Each Party agrees to give the other Party prompt written notice of the occurrence of any Force Majeure Event, the nature thereof, and the extent to which the affected Party will be unable fully to perform its obligations under the MSA. If a condition constituting Force Majeure Event as defined herein exists for more than one hundred eighty (180) consecutive days, the Parties shall negotiate a mutually satisfactory solution to the problem, if practicable, including termination of this MSA upon thirty (30) days written notice from the failure of reaching a mutually satisfactory solution to the Force Majeure Event, or the use of a third party to fulfill the obligations hereunder of the party invoking Force Majeure Event, at the expense of the party invoking Force Majeure Event.

 

 

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16.4

Assignment.

 

  16.4.1

This Agreement and all rights and obligations hereunder may not be Assigned or transferred by either Party, by operation of law or otherwise, without the express prior written consent of the other Party, which shall not be unreasonably withheld. Notwithstanding the foregoing, Client may, without SBL’s consent, Assign this Agreement in its entirety (a) to an Affiliate or (b) to a successor entity in the event of a merger, consolidation or change of control or (c) in connection with the transfer or sale of all or substantially all of the business or assets of the assigning party to which this Agreement relates. For clarity, withholding consent in the event of the potential assignee’s refusal to agree in writing to assume all rights and obligations under this MSA or a PSA shall not be deemed unreasonable. Any attempted Assignment in violation of this Section shall be deemed null and void for all purposes.

 

  16.4.2

In the event of an Assignment, the Party Assigning this Agreement or all rights and obligations hereunder shall be responsible for any and all additional costs and expenses incurred as a result of such an Assignment, including but not limited to any additional Services that need to be performed by SBL.

 

16.5

No Grant of License. Nothing in the MSA shall affect, or grant any right to, patents, know-how or other intellectual property owned by either Party prior to the commencement of the MSA unless otherwise expressly provided in the MSA.

 

16.6

No Right to Use Names. Except as expressly provided herein, no right, expressed or implied, is granted by the MSA to use in any manner the name of either of the Parties or any other trade name, symbol, logo or trademark of the other Party in connection with the performance of the MSA, without the prior written consent of the other Party.

 

16.7

Independent Contractors. The Parties hereto are independent contractors and nothing contained in the MSA shall be deemed or construed to create a partnership, joint venture, employment, franchise, agency or fiduciary relationship between the Parties.

 

16.8

Integration. This MSA constitutes the entire agreement between the Parties relating to the subject matter of the MSA and supersedes all previous oral and written communications between the Parties with respect to the subject matter of the MSA.

 

16.9

Decision Memo; Amendment; Waiver. A Decision Memo may be entered into by the Core Teams or JSCs with a binding effect, with it being understood that, in the event of a conflict between a Scope of Work, or Decision Memo and a later executed Decision Memo, the later executed Decision Memo shall prevail. Except as otherwise expressly provided herein, no alteration of or modification to the MSA shall be effective unless made in writing and executed by an authorized representative of both Parties. No course of dealing or failing of either Party to strictly enforce any term, right or condition of the MSA in any instance shall be construed as a general waiver or relinquishment of such term, right or condition. The observance of any provision of the MSA may be waived (either generally or any given instance and either retroactively or prospectively) only with the written consent of the Party granting such waiver.

 

16.10

Severability. The Parties do not intend to violate any applicable law. However, if any sentence, paragraph, clause or combination of the MSA is in violation of any law or is found to be otherwise unenforceable, such sentence, paragraph, clause or combination of the same shall be deleted and the remainder of the MSA shall remain binding, provided that such deletion does not alter the basic purpose and structure of the MSA.

 

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16.11

Construction. The Parties mutually acknowledge that they have participated in the negotiation and preparation of the MSA. Ambiguities, if any, in the MSA shall not be construed against any Party, irrespective of which Party may be deemed to have drafted the MSA or authored the ambiguous provision.

 

16.12

Interpretation. The captions and headings to the MSA are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of the MSA. Unless context otherwise clearly requires, whenever used in the MSA: (a) the words “include” or “including” shall be construed as incorporating, also, “but not limited to” or “without limitation”; (b) the words “hereof,” “herein,” “hereby” and derivative or similar words refer to the MSA; (c) all references to the word “will” are interchangeable with the word “shall” and shall be understood to be imperative or mandatory in nature. All references to days, months, quarters or years are references to calendar days, calendar months, calendar quarters, or calendar years. Whenever any matter hereunder requires consent or approval, such consent or approval shall not be unreasonably withheld or delayed.

 

16.13

Counterparts. This MSA 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.

IN WITNESS WHEREOF, the Parties have executed the MSA as of the date first above written.

Greenlight Biosciences, Inc.

 

Signature:  

/s/ Andrey Zarur

Name:   Andrey Zarur
Title:   CEO
Date:   11/22/2021

SAMSUNG BIOLOGICS CO., LTD.

 

Signature:  

/s/ John Rim

Name:   John Rim
Title:   CEO & President
Date:  

 

 

34

Exhibit 10.34

Certain identified information has been omitted from this exhibit because it is

not material and of the type that the registrant treats as private or confidential.

[***] indicates that information has been omitted.

SAMSUNG BIOLOGICS CO., LTD.

PRODUCT SPECIFIC AGREEMENT – CLINICAL PRODUCT DRUG SUBSTANCE

This Product Specific Agreement (this “PSA”) is made effective as of the date of last signature below (the “PSA Effective Date”) by and between GreenLight Biosciences, Inc., a Delaware corporation having its principal place of business at 200 Boston Avenue, Suite 1000, Medford, MA 02155 (“Client”) and Samsung Co., Ltd., a Korean corporation having its principal place of business at 300, Songdo bio-daero, Yeonsu-gu, Incheon, 21987, Republic of Korea (“SBL”). Client and SBL are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

WHEREAS, Client and SBL entered into a Master Services Agreement effective November 24, 2021 (the “MSA”) and whereas pursuant to Section 2.1 of the MSA, the Parties wish to enter into this PSA whereby SBL will provide certain Services as detailed herein;

NOW, THEREFORE, the Parties agree as follows:

 

1.

Relationship to the MSA. All capitalized terms not defined in this PSA will have the meanings given to them in the MSA. This PSA is hereby incorporated by reference into the MSA.

 

2.

Definitions

 

  a.

“Campaign” shall mean a series of Batches of the Product that are produced in sequence using the same manufacturing equipment followed by validated cleaning of such equipment and for the purposes of counting the number of Product batches in a Campaigns in a given period, the start date of such Campaign shall be the determining factor. A Campaign will be deemed to end upon the completion of such cleaning.

 

  b.

Product: GreenLight Biosciences mRNA COVID vaccine

 

  c.

“Product Purchase Commitment Shortfall” means the number of Batches of Product falling short of the Product Purchase Commitment.

 

  d.

“Year” means each one (1) year period that begins on January 1 and ends on December 31.

 

3.

General Information.

 

  a.

Clinical Product Specification: The Product Specification will be mutually agreed upon and set forth in cGMP documentation.

 

  b.

Manufacturing Facility: [***] scale mRNA facility in Plant #3, located at 300, Songdo bio-daero, Yeonsu-gu, Incheon 21987, Republic of Korea.

 

1


4.

Raw Materials.

 

  a.

Client Materials. Client Materials to be supplied by Client to SBL free of charge by itself or a third party designee.

 

  i.

List: See Exhibit A: Client Materials

 

  ii.

Timing of provision of Client Materials to SBL: one month in advance of production unless otherwise agreed to by the Parties. If Process Validation runs require additional testing, the Parties will mutually agree on the timing.

 

  b.

Raw Materials. As set forth in Section 4.6.1 of the MSA, the Parties shall finalize the categorization of Raw Materials to be used in performing the Services of this PSA into (i) Critical Raw Materials, (ii) Dedicated or Customized Raw Materials, and (iii) Other Raw Materials, which list shall form part of this PSA as Exhibit B.

 

  i.

Handling Fee for Customized or Dedicated Raw Materials and Other Raw Materials to be procured by SBL at Client’s expense: [***]. For a Batch, the Handling Fee shall be capped at [***].

 

  ii.

Handling Fee for Critical Raw Materials to be procured by SBL at Client’s expense: [***]. For a Batch, the Handling Fee shall be capped at [***].

 

5.

Technology Transfer, Manufacturing, and Supply Services. SBL shall perform the Services as set forth in this Section 5.

 

  a.

Services.

 

  i.

SBL shall provide the Services as set forth in Exhibit C in accordance with this PSA, Project Plan, or Scope of Work.

 

  ii.

Fees and invoicing.

 

  1.

Services shall be invoiced upon completion of activities by SBL, or as otherwise agreed by the Parties.

 

  2.

Bulk Drug Product Batches shall be invoiced according to Section 8.2.1 of the MSA.

 

  b.

Service Fees. In consideration for SBL’s performance of the Services pursuant to this Section 5, Client shall pay the Service Fees as set forth in Exhibit C. Additional Service Fees and costs may be detailed in an amendment to this PSA or in accordance with the MSA.

 

  c.

Product Purchase Commitment.

 

  i.

If the Parties execute a subsequent PSA for commercial production of Bulk Drug Product of the Product, the Parties agree that such subsequent PSA shall contain the following Product Purchase Commitment: [***]. Such PSA shall also include a term such that if Client makes an improvement to the Product manufacturing process which reduces facility time, the Parties shall in good faith reevaluate the Batch price.

 

 

2


  ii.

This PSA’s Product Purchase Commitment is [***]. Upon execution of this PSA, Client shall issue a Purchase Order for the Product Purchase Commitment, and such Purchase Order shall be fully binding on a minimum take or pay basis.

 

  iii.

Each Year, Client shall pay to SBL the price set forth in this PSA for each of the Product Purchase Commitment Shortfall, if any. For any Year for which a Product Purchase Commitment Shortfall payment is owed to SBL no later than December 31 of the Year when there is a Product Purchase Commitment Shortfall for such Year.

 

6.

2023 Capacity Right of First Refusal. [***]. For clarity after such right expires the Parties may nevertheless agree on the sale of such capacity to Client.

 

7.

Regulatory Approvals. The Regulatory Approvals covered by this PSA are the Food and Drug Administration (FDA), European Medicines Evaluation Agency (EMEA), and South African Health Products Regulatory Authority (SAHPRA)

 

8.

Storage. Pursuant to Section 4.12.2(a)(ii) of the MSA, if Client does not direct SBL to prepare Manufactured Commercial Product to be picked up by Client or Client’s designated carrier with a pick-up date within thirty (30) days of Client’s or Client’s designee’s receipt of the Batch Related Documents, SBL shall store the Commercial Product at the Warehouse and Client shall pay storage fees to SBL for the period of storage at the Warehouse until the actual delivery date. Storage fees shall be as follows: [***] per month per 10L bag.

 

9.

Outbound Technology Transfer. Once during the term of this PSA or upon its termination, SBL shall provide support for outbound technology transfer to a Client facility or a Third Party’s facility designated by the Client. The outbound technology transfer request must be made with at least six (6) months prior written notice. The scope of such outbound technology transfer will be mutually agreed upon scope of work but in no event shall SBL be obligated to provide more than two full time employee equivalent (“FTE”) months.

 

10.

Termination Fee for Termination without Cause. In the event Client terminates this PSA pursuant to MSA Section 14.2.1, the termination fee payable by Client shall be as follows: the value of the Product Purchase Commitment, to the extent not already paid prior to termination.

 

11.

Limitation of Liability. Notwithstanding Section 13.2 of the MSA, except with respect to Damages or allowable indirect damages arising under or in connection with this PSA arising out of (i) breaches of Sections 9 and 10 of the MSA; (ii) instances of gross negligence or willful misconduct (which shall not include Materials Claims); (iii) Materials Claims; and/or (iv) third party death or bodily injury caused by SBL to Client employees or contractors who may visit SBL sites, Client agrees that SBL’s aggregate total liability to Client in respect of any Ordinary Claims arising out of this PSA shall be

 

3


  capped at an amount equal to [***] the amounts payable by Client to SBL pursuant to this PSA. Client agrees that SBL’s aggregate total liability to Client in respect of any Materials Claims arising out of this PSA shall be capped at an amount equal to [***] of the amounts payable by Client to SBL under such PSA. SBL’s aggregate total liability to Client pursuant to this PSA for Materials Claims and Ordinary Claims combined shall never exceed [***] of the amounts payable by Client to SBL under such PSA.

 

12.

Term. This PSA will commence as of the PSA Effective Date and will continue in full force and effect until [***] or unless earlier terminated in accordance with the termination provisions of this PSA and/or the MSA.

The Parties have entered into this PSA as of the PSA Effective Date by their respective duly authorized representatives.

 

SAMSUNG BIOLOGICS CO., LTD.     GREENLIGHT BIOSCIENCES, INC.
By:  

/s/ John Rim

    By:  

/s/ Andrey Zarur

Name:   John Rim     Name:   Andrey Zarur
Title:       CEO & President     Title:       CEO

 

4


Exhibit A: Client Materials

[***]

 

5


Exhibit B: Categorization of Raw Materials

[***]

 

6


Exhibit C: Services

Estimated Project Timeline

 

   

Actual activity start dates may adjusted subject to the dates which Parties mutually agree after the execution of this PSA

[***]

mRNA Manufacturing Price

 

Service

  

Price (USD)

    
Stage 1    Project Management    [***]    Per year
Stage 2    Technology Transfer of IVT/LNP    [***]    One-time fee
Stage 3    Analytical Method Transfer    [***]    One-time fee, based on the list of analytical methods
Stage 4    Process Development and Scale-up    [***]   

To be further discussed

Highly scope dependent

Stage 5    Engineering Run    [***]    Per Bulk Drug Product batch
Stage 6    Process Characterization    [***]   

To be further delivered

Highly scope dependent

Stage 7    cGMP Run (Clinical or Process Validation)    [***]    Per Bulk Drug Product batch
OPTIONAL ACTIVITIES
Stage 8    Process Validation Planning and Study Execution    [***]    One-time fee
Stage 9   

Process Validation Run

(with option to release for human use)

   [***]    Per Bulk Drug Product batch
Stage 10    Cleaning Validation    [***]    [***]
Stage 11    Support for Regulatory Applications    [***]    Per filing
Stage 12    PAI Preparation & Inspection    [***]    Per inspection
Stage 13    PAI Campaign    [***]    Per Bulk Drug Product batch
Stage 14    Commercial Run    [***]   

Tier 1: [***]

Tier 2: [***]

Tier 3: [***]

Optional    Stability Testing    [***]   

Stability Set-up Fee

Per storage condition; per time point

Optional    pDNA synthesis starting in [***]    [***]   

 

*

Service fee for Stage 3, 4, 6, and 10 shall be updated based on further discussion with GreenLight Biosciences

PRICING AND PAYMENT ASSUMPTIONS

Standard pricing and payment terms are listed below.

 

   

The price is based on information provided in the RFP regarding the product and manufacturing process [***]. Further communication between Samsung Biologics and GreenLight Biosciences regarding the specifics of the project may result in changes to the scope of work and associated price. Any change in scope or price will be documented via an amendment to this PSA.

 

7


   

Tiered batch price is based on a single campaign per year and resets [***].

 

   

Commercial Run pricing is based on [***]. Further process details provided by GreenLight Biosciences may impact the pricing.

 

   

The assays listed in Appendix A2: Analytical Methods for Covid-19 Vaccine DS will be transferred.

 

   

Samsung Biologics will conduct Mycoplasma testing at Samsung Biologics’ QC (Quality Control) Laboratory, if requested.

 

   

The proposed prices are based on regulatory requirements that complies with FDA, EMEA, Canada, SAHPRA, and PMDA. Prices may change depending on the additional requirements necessary to comply with other regulatory authorities.

 

   

Unless otherwise noted, all batches are intended for human use and will be aseptically filled, 100% inspected, bulk packaged, shipped and released for further processing to the client. Client or Client’s designee is responsible for final product release.

 

   

Samsung Biologics will support shipping validation execution activities by following the Client packaging/preparation instructions; Client is accountable for shipping validation, strategy, execution and documentation.

 

8


Exhibit D: Scope of Work

[***]

 

9

Exhibit 23.1

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We hereby consent to the use in the Prospectus constituting a part of this Registration Statement on Amendment No. 2 to Form S-4, of our report dated March 26, 2021, relating to the financial statements of Environmental Impact Acquisition Corp. which is contained in the Prospectus. We also consent to the reference to us under the caption “Experts” in the Prospectus.

/s/ WithumSmith+Brown, PC

New York, New York

December 6, 2021

EXHIBIT 23.2

CONSENT OF THE INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We consent to the use in this Registration Statement No. 333-259375 on Form S-4 of our report dated September 7, 2021, relating to the financial statements of GreenLight Biosciences, Inc. We also consent to the reference to us under the heading “Experts” in such Registration Statement.

/s/ Deloitte & Touche LLP

Boston, Massachusetts

December 6, 2021

Exhibit 99.2

CONSENT OF DUFF & PHELPS

Duff & Phelps, A Kroll Business operating as Kroll, LLC (“Duff & Phelps”) hereby consents to (i) the filing of our fairness opinion dated August 9, 2021 (the “Opinion”) to the Board of Directors of Environmental Impact Acquisition Corp. (“ENVI”) as Annex K to this Registration Statement on Form S-4, (ii) the references therein to Duff & Phelps and (iii) the inclusion therein of (a) the summaries of and excerpts from the Opinion, (b) the description of certain financial analyses underlying the Opinion and (c) certain terms of our engagement by the Board of Directors of ENVI. In giving such consent, we do not thereby admit that we are in the category of persons whose consent is required under Section 7 of the Securities Act of 1933.

 

 

Duff & Phelps, A Kroll Business

  
    

/s/ Christopher L. Janssen

  
 

By:

  

Christopher L. Janssen

  
 

Title:

  

Managing Director

  
 

Kroll, LLC

 

December 6, 2021

  


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