Contract
Exhibit 10.7
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.
|
CUSTOMER INFORMATION |
|
|
Name: |
Biological E. Limited (“Customer”) |
|
Mailing Address: |
00/0&0, Xxxxxxxx Xxxxxxxxx-000000, Xxxxxxxxx Xxxxx |
|
Designated Contact: |
Raju PV Sr. Vice President, SCM Xxxx.XX@xxxxxxxxxxx.xxx x00 0000000000 |
|
SUPPLIER INFORMATION |
|
|
Name: |
Dynavax Technologies Corporation (“Dynavax”) |
|
Mailing Address: |
0000 Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxxxx, XX 00000, XXX |
|
Designated Contact: |
Xxxxx Xxxxxx xxxxxxx@xxxxxxx.xxx x0-000-000-0000 |
|
AGREEMENT INFORMATION |
|
|
Parties: |
Customer and Dynavax (each a “Party” and collectively the “Parties”) |
|
Effective Date: |
Date on which the Supply Agreement is signed by second Party. |
|
Expiration Date: |
31 December 2022, subject to extension by mutual written agreement of the Parties in accordance with Section 14.1 of Annex B hereto. |
|
Currency for all prices, payments and charges: |
USD (United States Dollars) |
|
The supply agreement (the “Supply Agreement”) between Customer and Dynavax consists exclusively of and incorporates by reference: |
- This Supply Agreement Summary - Annex A: Scope and Pricing Schedule - Annex B: General Terms and Conditions for the Supply of Dynavax Adjuvant
|
|
Signed for and on behalf of Dynavax Technologies Corporation by:
Signature: /s/ Xxxxx Xxxxxx
Name: Xxxxx Xxxxxx
Title: President and COO
Date: Jul-01-2021
|
Signed for and on behalf of Biological E. Limited by:
Signature: /s/ Xxxxxx Xxxxx
Name: Xxxxxx Xxxxx
Title: Managing Director
Date: Jul-01-2021
|
Annex A: Scope and Pricing Schedule
|
Dynavax Adjuvant Name: |
Dynavax CpG 1018 |
|
Form of Supply: |
Liquid bulk formulation of Dynavax CpG 1018 in [***], at a concentration of [***] mg/ml, provided that, for each full batch of Dynavax CpG 1018 manufactured, the [***]. Must be ordered in whole numbers of containers. |
|
Dose: |
Dose means [***], including overage. |
|
Adjuvant Price per Dose: |
LMIC Price. For Dynavax Adjuvant in Customer Product(s) sold in countries supported by the Advance Market Commitment of the COVAX Facility as listed at the following website: xxxxx://xxx.xxxx.xxx/xxxx/xxxxx-xxxx/00-xxx-xxxxxx-xxxxxx-xxxxxxxxx-xxxxxxxx-xxxxxx-xxxxx-00-xxxxxxxx-xxxx-xxxxx-xxx (“LMICs”); but excluding Dynavax Adjuvant in Customer Product(s) sold in private markets within LMICs: • USD [***] per Dose [***]; and • USD [***] per Dose [***]; in each case, the “LMIC Price” for the applicable Dose. UMIC Price. For Dynavax Adjuvant in Customer Product(s) sold in countries listed at the following website (and as updated from time to time)as “upper middle income” countries: xxxxx://xxxx.xxxxxxxxx.xxx/xxxxxx-xxxxx/xxxxx-xxxxxx-xxxxxx (“UMICs”) or in private markets within LMICs; but excluding Dynavax Adjuvant in Customer Product(s) sold in private markets within UMICs: • USD [***] per Dose [***]; and • USD [***] per Dose [***]; in each case, the “UMIC Price” for the applicable Dose. HIC Price. For Dynavax Adjuvant in Customer Product(s) sold in countries that are neither LMICs nor UMICs (“HICs”) or in private markets within UMICs: • USD [***] per Dose [***]; and • USD [***] per Dose [***]; in each case, the “HIC Price” for the applicable Dose. Dynavax shall [***] quantity of Dynavax Adjuvant [***] in each of the categories listed above. In the event Dynavax [***] the Dynavax Adjuvant [***] quantity of Dynavax Adjuvant [***], then Dynavax shall [***]. For clarity, the foregoing [***] in case Dynavax [***], and shall [***] quantity of Dynavax Adjuvant [***].
For avoidance of doubt, if any country categorized as an LMIC also qualifies as a UMIC as defined above, then, the LMIC Price shall apply for the Price per Dose in such an event. Royalty. As per Section 6.4 of Annex B of the Supply Agreement, a royalty of [***]% will be payable to Dynavax on any Net Sale of Customer Product(s) under a Bilateral Agreement exceeding a Net Sale Per Unit of $[***]. For clarity, no royalty will be payable with respect to Customer Product(s) sold under any COVAX Supply Agreement or GAVI Customer Agreement. |
-1
|
Order # |
Quarter (manufacturing) |
Order Quantity Doses (kg) |
Order Due Date |
Delivery Date |
|
1 |
[***] |
[***] |
[***] |
[***] 2021 [***] |
|
2 |
[***] |
[***] |
[***] |
[***] 2022 |
|
3 |
[***] |
[***] |
[***] |
[***] 2022 |
|
4 |
[***] |
[***] |
[***] |
[***] 2022 |
|
5 |
[***] |
[***] |
[***] |
[***] 2022 |
|
* |
The Parties acknowledge that [***]. Should any additional quantity of Dynavax Adjuvant become available for delivery in Q1 2022, Dynavax shall offer such additional Dynavax Adjuvant, up to a maximum of an additional [***] Doses [***] of Dynavax Adjuvant (the “Additional Q1 2022 Dynavax Adjuvant”), to Customer by written notice, stating the available quantity of Additional Q1 2022 Dynavax Adjuvant, and Customer shall have [***] Business Days from delivery of such notice (the “First Offer Period”) in which to submit an Order for such Additional Q1 2022 Dynavax Adjuvant (or a portion thereof) as described in Section 2.1 of Annex B of the Supply Agreement. |
Notwithstanding the table above, the timing for ordering and manufacturing and the timing for delivery for Q3 and Q4 of 2021 may be delayed, and the quantities for Q3 and Q4 of 2021 may be modified, by CEPI in its sole discretion.
Rows 1 and 2 of the table above constitute a binding commitment on the part of Customer to order the applicable quantities set forth in the table above, except to the extent that any such quantities are modified by CEPI.
-2
Annex B: General Terms and Conditions for the Supply of Dynavax Adjuvant
The following definitions and rules of interpretation apply in these Conditions.
“Additional Q1 2022 Dynavax Adjuvant” has the meaning given in Annex A of the Supply Agreement.
“Adjusted Net Sales Per Unit” means, in any accounting period, the amount (if any) by which Net Sales Per Unit exceeds the Unit Threshold Price.
“Anti-Corruption Laws” means the U.S. Foreign Corrupt Practices Act (15 U.S.C. §§78dd-1, et. seq.), as amended, the Organization for Economic Co-operation and Development (OECD) Convention on combating bribery of foreign public officials in international business transactions, the UK Xxxxxxx Xxx 0000, as amended, and any subordinate legislation made under that Act from time to time together with any guidance and/or codes of practice issued by the relevant government department concerning the legislation, and any other applicable laws of similar effect, and the related regulations and published interpretations thereunder.
“Applicable Laws” means all national and supranational laws and regulations and other mandatory professional regulations applicable to a Party or a Party’s activities or obligations described under or pursuant to the Supply Agreement, including but not limited to, Anti-Corruption Laws, Data Protection Legislation and cGMP.
“Authorized Third Party” has the meaning given in Section 10.5.
“Bilateral Agreement” means any agreement entered into between Customer and a third party, outside any COVAX Supply Agreement or GAVI Customer Agreement, for the supply of the Customer Product(s).
“Binding Quantities” has the meaning given in Section 3.1.
“Bioequivalent Adjuvant” means a CpG oligodeoxynucleotide with the same sequence as Dynavax Adjuvant that is not manufactured by or on behalf of Dynavax.
“Biosimilar Version” means, with respect to any Customer Product that is being sold in a country or regulatory jurisdiction (the “Reference Product”), any biopharmaceutical product sold by a third party (other than a third party acting on behalf of or in concert with Customer, any of its affiliates, any Licensee, or any sublicensee or assignee of any of the foregoing) in such country or jurisdiction, that through reference to the Regulatory Approval of the Reference Product, is eligible for and has achieved regulatory approval in such country or jurisdiction pursuant to an abbreviated follow-on biological approval pathway established by the Regulatory Authority in such country or jurisdiction pursuant to the Applicable Laws, or otherwise is approved for marketing and sale in such country or jurisdiction by an abridged procedure in reliance, in whole or in part, on the prior Regulatory Approval of the Reference Product or on the safety and efficacy data included in the prior Regulatory Approval (in such country or jurisdiction) of the Reference Product, including any such biopharmaceutical product that (i) with respect to such biopharmaceutical product in the United States, has been approved as a biosimilar or interchangeable product by the FDA pursuant to 42 U.S.C. § 262 of the Public Health Service Act, or (ii) with respect to such biopharmaceutical product in any country or regulatory jurisdiction, has otherwise obtained Regulatory Approval from a Regulatory Authority pursuant to similar statutory or regulatory requirement as that described in the foregoing clause (i) in such other country or jurisdiction.
B-1
“Business Day” means a day other than a Saturday, Sunday or public holiday in the United States of America and/or India.
“CMO Quality Agreement” means the quality agreement between Dynavax and the Dynavax CMO setting out the responsibilities of Dynavax and the Dynavax CMO in relation to quality of the Dynavax Adjuvant supplied under this Supply Agreement.
“CEPI” means the Coalition for Epidemic Preparedness and Innovations.
“CEPI Agreement” has the meaning given in Section 3.4.
“CEPI Reserved Material” has the meaning given in Section 3.4.
“COA” means the Certificate of Analysis issued by Dynavax for the Dynavax Adjuvant in each delivery for the Customer, summarizing the batch number, manufacturing date, expiry date or retest date, analytical parameters & testing results on samples of the Dynavax Adjuvant in that delivery together with the evaluation of compliance to the Specifications.
“COC” means the certificate of compliance issued by Dynavax to Recipient with each shipment of Dynavax Adjuvant that states (i) the batch number, manufacturing date, and (ii) that the Dynavax Adjuvant supplied to Customer thereunder were manufactured in accordance with all Applicable Laws.
“Collaboration Agreements” means (a) the Clinical Collaboration Agreement between Dynavax and Customer dated October 16, 2020, as amended (the “Clinical Collaboration Agreement”), and (b) the Collaboration Agreement between Dynavax and Customer dated June 29, 2020, as amended (the “Collaboration Agreement”).
“Conditions” means the terms and conditions of this Annex B, as amended from time to time in accordance with Section 17.9 hereof.
“Confidential Information” confidential or proprietary information disclosed by or on behalf of a Party or any of its affiliates (the “Disclosing Party”) to the other Party or any of its affiliates (the “Receiving Party”) under the Supply Agreement or the NDA (including under any Collaboration Agreement), either directly or indirectly, in writing, orally, electronically or through other means, and whether or not designated as “confidential” at the time of disclosure, including without limitation, information relating to compounds, biological sequences, inventions (including patent applications covering such inventions), trade secrets, specifications, formulations, designs, data, know-how, results, regulatory affairs, clinical trials and protocols, customers, suppliers, collaborators, funders, employees, consultants, partners, clients or sales and marketing information, development work, project timetables, manufacturing processes, analytical processes, and other confidential or proprietary information, processes, services and business of the Disclosing Party including new know-how and information developed by the Disclosing Party under the Supply Agreement, data, information, and any improvements, modifications, derivations, or compilations thereto, provided however, that Confidential Information shall not include any information which:
|
|
(a) |
Was known by or in the possession of the Receiving Party prior to its date of disclosure to the Receiving Party by or on behalf of the Disclosing Party, as demonstrated by the written records of the Receiving Party; |
|
|
(b) |
Either before or after the date of the disclosure to the Receiving Party by or on behalf of the Disclosing Party, is lawfully disclosed to the Receiving Party by sources other than the Disclosing Party; |
B-2
|
|
(c) |
Either before or after the date of the disclosure to the Receiving Party by or on behalf of the Disclosing Party, was or becomes publicly known through no fault or omission on the part of the Receiving Party; or |
|
|
(d) |
Is or was independently developed by or for the Receiving Party without use of the Confidential Information as evidenced by the written records of the Receiving Party. |
Without limiting the generality of the foregoing definition, Confidential Information of Dynavax includes Dynavax Manufacturing Information.
“COVAX” means the global organization COVAX, one of three pillars of the Access to COVID-19 Tools (ACT) Accelerator which is coordinated by GAVI, CEPI and the World Health Organization (WHO) to act as a platform to support the research, development and manufacturing of a wide range of COVID-19 vaccine candidates, and to negotiate their pricing.
“COVAX Supply Agreement” means any agreement entered into between Customer and COVAX for the supply of Customer Product(s).
“Current Good Manufacturing Practice” or “cGMP” means the minimum standard that a medicines manufacturer must meet in their production processes in accordance with (i) 21 C.F.R. Parts 210 and 211, (ii) Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use, (iii) Volume 4 of the Rules Governing Medicinal Products in the European Union, EU Guidelines for Good Manufacturing Process for Medicinal Products for Human and Veterinary Use, Chapter 7 (Outsourced Activities) and (iv) all relevant regulations or guidance for WHO Prequalification, in each case (i) – (iv) above as amended, supplemented or superseded from time to time.
“Customer” has the meaning set forth in the Supply Agreement Summary.
“Customer Product” means a product containing or comprising a combination of Customer Vaccine and Dynavax Adjuvant supplied by Dynavax hereunder (whether such Dynavax Adjuvant is formulated with the Customer Vaccine in the same vial or separately from the Customer Vaccine in an accompanying vial).
“Customer Vaccine” means: (a) the antigen(s) comprising of a protein sub-unit derived from SARS-CoV-2 virus spike protein (wild-type and variants), adjuvanted with alum, that is being developed, manufactured or commercialized by or on behalf of Customer or its affiliates or their Licensees as a COVID‑19 vaccine as of the Effective Date; or (b) any other antigen (with respect to the wild type or any variant of SARS-COV-2) that is developed, manufactured or commercialized by or on behalf of Customer or its affiliates or their Licensees as a COVID‑19 vaccine, with or without alum, that is identified by Customer to Dynavax in writing pursuant to Section 3.2. For clarity, Customer Vaccine does not include Dynavax Adjuvant.
“Data Protection Legislation” means all applicable data protection and privacy legislation in force from time to time, including Regulation (EU) 2016/679 (the General Data Protection Regulation) and any other applicable legislation relating to personal data and all other legislation and regulatory requirements in force from time to time which apply to a Party relating to the use of personal data (including, without limitation, the privacy of electronic communications) pursuant to the Supply Agreement; and the guidance and codes of practice issued by the relevant data protection or supervisory authority and applicable to such Party.
“Defect” or “Defective Product” means any failure of the Dynavax Adjuvant supplied hereunder (i) to conform to the Specifications, or (ii) to have been manufactured in accordance with cGMP.
B-3
“Delivery Location” has the meaning given in Section 4.2.
“Dose” has the meaning described in Annex A of the Supply Agreement.
“Dynavax” means Dynavax Technologies Corporation.
“Dynavax Adjuvant” means Dynavax’s proprietary CpG 1018 adjuvant (as further described in Annex A), manufactured by or on behalf of Dynavax.
“Dynavax CMO” means Nitto Denko Avecia, Inc. and/or any other third party contract manufacturer engaged by Dynavax to manufacture Dynavax Adjuvant on behalf of Dynavax.
“Dynavax Manufacturing Information” means information or documentation in the possession or under the control of Dynavax relating to the development or manufacture of the Dynavax Adjuvant, that, in each case: (a) is contained in any Dynavax Regulatory Filing that Dynavax authorizes Customer or any Regulatory Authority to reference or use in connection with Customer or any of its affiliates, Licensees or Authorized Third Party, applying for, obtaining or maintaining Regulatory Approval for any Customer Product; or (b) is submitted by or on behalf of Dynavax to any Regulatory Authority for use or reference in connection with Customer or any of its affiliates, their Licensees or any Authorized Third Party, applying for, obtaining or maintaining Regulatory Approval for any Customer Product; or (c) is disclosed or provided by or on behalf of Dynavax to Customer or any of its affiliates for submission to any Regulatory Authority in connection with Customer or any of its affiliates, or their Licensees or any Authorized Third Party, applying for, obtaining or maintaining Regulatory Approval for any Customer Product. Without limiting the generality of the foregoing, Dynavax Manufacturing Information includes the Specifications. In addition, the identity and concentration tests for Dynavax Adjuvant to transferred to Customer pursuant to Section 3.8 shall constitute Dynavax Manufacturing Information.
“Dynavax Regulatory Filing” means any filing or submission by or on behalf of Dynavax or any of its affiliates with or to any Regulatory Authority regarding the Dynavax Adjuvant.
“Effective Date” means the effective date specified in the Supply Agreement Summary.
“Expiration Date” means the expiration date specified in the Supply Agreement Summary.
“Export Control Laws” shall mean: (a) all applicable U.S. laws and regulations relating to sanctions and embargoes imposed by U.S. Department of Treasury’s Office of Foreign Assets Control (or its successor office or other body having substantially the same function); (b) all applicable U.S. export control laws, including the Arms Export Controls Act (22 U.S.C. Ch. 39), the International Emergency Economic Powers Act (50 U.S.C. §§ 1701 et seq.), the Trading With the Enemy Act (50 U.S.C. app. §§ 1 et seq.), the Export Administration Act of 1979 (50 U.S.C. app. §§ 2401 et seq.), International Boycott Provisions of Section 999 of the U.S. Internal Revenue Code of 1986, and all rules, regulations and executive orders relating to any of the foregoing, including but not limited to the International Traffic in Arms Regulations (22 C.F.R. §§ 120 et seq.), the Export Administration Regulations (15 C.F.R. §§ 730 et. seq.), and the regulations administered by the Office of Foreign Assets Controls of the United States Department of the Treasury; and (c) all export controls imposed on any Dynavax Adjuvant by any country or organization or nation within the jurisdiction of which either Party operates or does business.
[***] has the meaning given in Section 4.9.
[***] has the meaning given in Section 3.8.
“First Offer Period” has the meaning given in Annex A of the Supply Agreement.
B-4
“Force Majeure Event” means any circumstance not within a Party’s reasonable control including, without limitation:
|
|
(e) |
acts of God, flood, drought, earthquake or other natural disaster; |
|
|
(f) |
epidemic or pandemic; |
|
|
(g) |
terrorist attack, civil war, civil commotion or riots, war, threat of or preparation for war, armed conflict, imposition of sanctions, embargo, or breaking off of diplomatic relations; |
|
|
(h) |
nuclear, chemical or biological contamination or sonic boom; |
|
|
(i) |
any law or action taken by a government or public authority, including without limitation imposing an export or import restriction, quota or prohibition; |
|
|
(j) |
collapse of buildings, fire, explosion or accident; and |
|
|
(k) |
any labor or trade dispute, strikes, industrial action or lockouts (excluding any labor or trade dispute, strike, industrial action or lockout confined to Dynavax’s workforce). |
“GAVI” means the GAVI Alliance (formerly the Global Alliance for Vaccines and Immunisation), which is a global health partnership of public and private sector organizations dedicated to “immunisation for all.”
“GAVI Customer Agreement” means any agreement entered into between GAVI and Customer for the purchase of Customer Product(s).
“HIC Price” has the meaning given in Annex A.
“HICs” has the meaning given in Annex A.
“Intellectual Property Rights” means patents, patent applications, rights to inventions, know-how, and other intellectual property rights, in each case whether registered or unregistered and including all applications and rights to apply for and be granted, renewals or extensions of, and rights to claim priority from, such rights and all similar or equivalent rights or forms of protection which subsist or will subsist now or in the future in any part of the world.
“Latent Defect” means a Defect in any Dynavax Adjuvant delivered hereunder that could not be discovered by (a) (i) the testing / certification procedures by Dynavax / Dynavax CMO prior to the issuance of the COA and COC, and (ii) testing by Customer pursuant to Section 3.7; and (b) a reasonable visual inspection (i) prior to delivery by Dynavax / Dynavax CMO, and (ii) following receipt by Customer within the timeframe specified under Section 4.6.
“Licensee” means any third party to which Customer or its affiliate has granted a license to develop, manufacture or commercialize Customer Product(s).
“LMIC Price” has the meaning given in Annex A.
“LMICs” has the meaning given in Annex A.
“NDA” means that certain Mutual Non-Disclosure Agreement between Dynavax and Customer dated May 26, 2020.
“Net Sales” means, in any accounting period, the gross amounts invoiced by Customer, its affiliates and their respective Licensees (each, a “Selling Party”) for sales of Customer Product(s)
B-5
to third parties (other than Selling Parties), but excluding sales of Customer Product(s) under any COVAX Supply Agreement or GAVI Customer Agreement, less the following, to the extent actually granted, allowed, incurred or paid by the Selling Party and specifically attributable to such sales of Customer Product(s):
|
|
(l) |
normal and customary trade discounts, including trade, cash and quantity discounts or trade rebates, credits or refunds, or retroactive price reductions; |
|
|
(m) |
credits or allowances additionally granted upon returns, rejections or recalls, allowances for uncollectible amounts or bad debts on previously sold Customer Product(s), provided that Customer shall use commercially reasonable efforts to collect such uncollectible amounts and any such amounts shall be included in Net Sales if and at such time as subsequently received; |
|
|
(n) |
rebates, chargebacks, credits and discounts (or the equivalent thereof) accrued and actually paid, credited or granted to any third party including governmental agency (or agent or branch thereof) or to any third party payor, administrator or contractee, including managed healthcare organizations, pharmacy benefit managers (or equivalent thereof) or their agencies, purchasers, reimbursers, or trade customers; |
|
|
(o) |
charges for tertiary packaging, outbound freight, insurance, transportation, postage and handling; and |
|
|
(p) |
tariffs, taxes, excises, customs duties and other governmental charges (including any tax such as a value added or similar tax, GST or government charge, except to the extent reimbursed, but excluding income tax) levied on or measured by the production, sale, transportation, delivery or use of Customer Product(s) and actually paid, as adjusted for rebates and refunds. |
All aforementioned deductions shall only be allowable to the extent they are (i) calculated in a manner consistent with the Selling Party’s customary practice for pharmaceutical products and, in any event, in accordance with U.S. Generally Accepted Accounting Principles or International Financial Reporting Standards, consistently applied by such Selling Party, and (ii) reasonably allocable to Customer Product, or apportioned on a good faith, fair and equitable basis to Customer Product. No particular amount identified above shall be deducted more than once in calculating Net Sales (i.e., no “double counting” of deductions).
For clarification, sale of Customer Product by a Selling Party to another Selling Party for resale by such other Selling Party to a third party (other than a Selling Party) shall not be deemed a sale for purposes of this definition of “Net Sales,” provided that the subsequent resale to such third party is included in the computation of Net Sales. In the event of any sale of Customer Product for any consideration other than exclusively monetary consideration on bona fide arm’s-length terms (including any sale of Customer Product by a Selling Party to another Selling Party for end use by such other Selling Party), then for purposes of calculating Net Sales under these Conditions, such Customer Product shall be deemed to have been sold exclusively for cash at the weighted (by sales volume) average sale price of such Customer Product in bona fide arm’s-length transactions (when sold alone, and not with other products) in the applicable country in which such sale occurred during the applicable accounting period. Customer Product(s) provided to third parties without charge in connection with research and development, clinical trials, compassionate use, humanitarian and charitable donations, or indigent programs shall be excluded from the computation of Net Sales.
“Net Sales Per Unit” means, in any accounting period, the amount determined by dividing (x) total Net Sales of Customer Product(s) in such period by (y) Units Sold in such period.
B-6
“Order” or “Order Form” has the meaning given in Section 2.2.
“Party” or “Parties” has the meaning set forth in the Supply Agreement Summary.
“Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture, or other similar entity or organization, including a government or political subdivision, department, or agency of a government.
“Pharmacovigilance Agreement” means the agreement between Dynavax and Customer setting out the pharmacovigilance responsibilities of the Parties in relation to the Dynavax Adjuvant.
“Quality Agreement” means the quality agreement between Customer and Dynavax setting out the responsibilities of the Parties in relation to quality of the Dynavax Adjuvant supplied hereunder as required for compliance with cGMP of the applicable country or jurisdictions.
“Quarter” means a period of three calendar months starting on 1st January, 1st April, 1st July and 1st October respectively in each calendar year. “Q1” shall refer to the first Quarter of the calendar year that it refers to, “Q2” shall refer to the second Quarter of the calendar year that it refers to, “Q3” shall refer to the third Quarter of the calendar year that it refers to, “Q4” shall refer to the fourth Quarter of the calendar year that it refers to. By way of illustration, “Q4 2021” refers to the period starting 1st October 2021 and ending 31st December 2021. “Quarterly” shall be construed accordingly.
“Regulatory Approval” means in relation to any country and any Customer Product, any approval (including emergency use approvals and conditional use approval) granted by the appropriate Regulatory Authority to research, develop, manufacture, use, offer for sale, import, export, distribute, promote, price, market or sell the Customer Product in that country, whether filed or held in the name of Customer, any affiliate of Customer, any Licensee or any Authorized Third Party.
“Regulatory Authority” means any competent government agency, regulatory authority or other administrative body, including WHO, responsible for regulating or otherwise exercising authority with respect to the research, development, manufacture, sale, import, export, distribution, promotion, regulatory approval (including regulatory or marketing approval), pricing or reimbursement of medicinal products.
“Remaining Stock” means any Dynavax Adjuvant supplied by Dynavax to Customer or any of its affiliates pursuant to the Supply Agreement that (a) remain in the possession or control of Customer or any of its affiliates or their Licensees (including any such Dynavax Adjuvant in the physical possession of a third party contractor that is being held on behalf of Customer, its affiliate or a Licensee) as of the expiry or termination of the Supply Agreement or (b) are delivered by Dynavax to Customer or any of its affiliates after the expiry or termination of this Agreement in accordance with Section 15.
“Selling Party” has the meaning provided in the definition of Net Sales.
“Specifications” means the specifications for the Dynavax Adjuvant as set forth in the Quality Agreement, as they may be amended from time to time in accordance with the Quality Agreement. As of the Effective Date, the Specifications are the same as or tighter than those of the Product (as defined in the Clinical Collaboration Agreement) that was supplied under the Clinical Collaboration Agreement.
“Supply Agreement” has the meaning provided in the Supply Agreement Summary.
B-7
“Term” means the period beginning on the Effective Date and, subject to earlier termination of the Supply Agreement in accordance with Section 14 of these Conditions, expiring on the Expiration Date.
“UMIC Price” has the meaning given in Annex A.
“UMICs” has the meaning given in Annex A.
“Uncancellable” means with respect to orders for the manufacture of Dynavax Adjuvant placed with the Dynavax CMO in response to Orders from Customer, such orders that cannot be cancelled by Dynavax using commercially reasonable efforts, without Dynavax incurring any out-of-pocket cost as a result of such cancellation.
“Unit” of Customer Product means the amount of Customer Product required and sufficient for a single immunization of one (1) patient.
“Units Sold” means, for any accounting period, the number of Units of Customer Product sold by the Selling Parties in such accounting period that are included in the computation of Net Sales. For clarity, “Units Sold” in an accounting period exclude Customer Product(s) provided to third parties without charge in connection with research and development, clinical trials, compassionate use, humanitarian and charitable donations, or indigent programs in such accounting period.
“Unit Threshold Price” means [***] per Unit of Customer Product.
|
|
(a) |
any headings in the Supply Agreement shall not affect the scope/interpretation of the Supply Agreement; |
|
|
(b) |
except where the Supply Agreement expressly specifies Business Days, all references to numbers of days in the Supply Agreement refer to calendar days; |
|
|
(c) |
unless the context otherwise requires reference to the singular includes the plural and vice versa, any reference to a person includes a body corporate and words importing one gender include both genders; |
|
|
(d) |
a reference to a statute or statutory provision is (unless otherwise stated) a reference to the applicable country’s or regulatory jurisdiction’s statute as it is then in effect, taking account of any amendment, extension, or re-enactment, and includes any subordinate legislation made under it that is then in effect; |
|
|
(e) |
where the words “include(s)” or “including” are used in the Supply Agreement, they are deemed to have the words “without limitation” following them, and are illustrative and shall not limit the sense of the words preceding them; |
|
|
(f) |
references to Annexes are references to Annexes of the Supply Agreement; and |
|
|
(g) |
references to Sections are references to Sections of these Conditions (including all subsections thereof, if any) unless otherwise specified. |
|
1.3 |
In the event of any conflict/inconsistency between the terms of this Supply Agreement and: |
|
|
(a) |
the terms of the Quality Agreement, the Quality Agreement shall govern for all quality-related matters and the Supply Agreement shall govern for all other matters; |
B-8
|
|
(b) |
the terms of the Pharmacovigilance Agreement, the Pharmacovigilance Agreement shall govern for all pharmacovigilance-related matters and the Supply Agreement shall govern for all other matters; |
|
2.4 |
Any Orders for Dynavax Adjuvant submitted by Customer shall reference the Supply Agreement and shall be governed exclusively by the terms contained herein. Unless mutually agreed to by the Parties in writing, any term or condition in any Order Form, purchase order, confirmation, or other document furnished by Customer or Dynavax that is in any way inconsistent with, or in addition to, the terms and conditions set forth in the Supply Agreement is hereby expressly rejected. |
|
3.2 |
Except to the extent otherwise expressly permitted by Section 4.9 in the event of [***], during the Term and subject to [***], Customer (a) [***], (b) [***], and (c) [***]. For clarity, [***]. |
B-9
|
3.5 |
Customer and Dynavax shall enter into a Quality Agreement and Pharmacovigilance Agreement, each in a form reasonable and typical for the industry, within thirty (30) days of the Effective Date. The Quality Agreement shall include provisions covering inter alia recalls of Customer Product(s), and Dynavax Adjuvant and the respective responsibilities of the Parties. |
B-10
|
promulgated thereunder (the “Act”); (d) not be articles that, under the provisions of the Act, may not be introduced into interstate commerce; and (e) be free and clear of any lien or encumbrance. |
|
3.12 |
Notwithstanding anything to the contrary in the Supply Agreement including this Section 3, Customer [***]. |
|
|
(a) |
the Dynavax Adjuvant is properly packed and secured in a manner reasonably determined by Dynavax to be appropriate for shipping; |
|
4.2 |
Dynavax shall deliver the Dynavax Adjuvant within five (5) Business Days of the delivery date specified in the Order and to the location set out in the Order or as otherwise agreed by the Parties |
B-11
|
before delivery (“Delivery Location”). Dynavax shall not be responsible for any delay in delivery of Dynavax Adjuvant to the extent caused by a third party carrier. |
B-12
|
Adjuvant to Customer within six (6) months of such determination at no additional cost to the Customer. |
In the event of [***]:
|
|
(a) |
[***]; |
|
|
(b) |
[***]; and |
|
|
(c) |
[***]. |
B-13
|
5.4 |
The Parties hereby agree that all rights to any invention, whether or not patentable, that is generated by or on behalf of Customer in the course of using any of the Dynavax Adjuvant supplied hereunder or developing, using, manufacturing or having manufactured Customer Product(s), that, in each case, [***] shall be [***] and [***]. |
The Parties hereby agree that [***]. The Parties agree that [***].
|
5.5 |
Dynavax and Customer shall [***]. The Parties agree that [***]. Customer hereby grants Dynavax (a) [***], and (b) [***]. Dynavax hereby grants Customer (a) [***]; and (b) [***]. . |
|
5.6 |
In the event a [***]Invention is created by a Party, such Party shall notify the other Party without delay including provision of details of such [***]Invention. [***]. |
|
5.7 |
In the event a Party becomes aware of any suspected infringement of [***] by a third party, it shall notify the other Party without delay. The Parties will discuss in good faith the best way forward. |
B-14
|
5.8 |
No right or license under any Intellectual Property Rights of a Party is granted or shall be granted to the other Party by implication, estoppel or otherwise. Any such rights or licenses are or shall be granted only as expressly provided in the Supply Agreement. |
|
5.9 |
The Parties acknowledge and agree that the Supply Agreement is not a “joint research agreement” as defined in 35 U.S.C. § 100(h), and neither Party shall invoke the America Invents Act Joint Research Agreement exception codified at 35 U.S.C. § 102(c) (or any equivalent law outside the United States) in exercising any of its rights under the Supply Agreement without the prior written consent of the other Party. |
|
5.11 |
Notwithstanding anything to the contrary in the Supply Agreement including this Section 5, nothing in the Supply Agreement is intended to or shall be construed to [***]. |
|
6.1 |
Prices. The prices for the Dynavax Adjuvant shall be as set forth in Annex A, subject to Section 6.3. |
B-15
|
|
the amounts invoiced under Sections 6.2(a) and 6.2(b) as soon as practicable after, and in any event within fifteen (15) days of, the date of receipt of the invoice to a bank account designated in writing by Dynavax. |
For purposes of performing such trueing up exercise, within ten (10) Business Days after the end of each Quarter, the Customer shall report to Dynavax: (i) the total number of Doses of Dynavax Adjuvant contained in all Units of Customer Product(s) Disposed of by or on behalf of Customer in LMICs (excluding private markets in LMICs) during such Quarter; (ii) the total number of Doses of Dynavax Adjuvant contained in all Units of Customer Product(s) Disposed of by or on behalf of Customer (a) in UMICs (excluding private markets in UMICs) and (b) for private markets in LMICs during such Quarter; and (iii) the total number of Doses of Dynavax Adjuvant contained in all Units of Customer Product(s) Disposed of by or on behalf of Customer (a) in HICs and (b) for private markets in UMICs, in each case, during such Quarter.
If the total number of Doses of Dynavax Adjuvant invoiced by Dynavax to Customer at the LMIC Price in such Quarter exceeds the total number of Doses of Dynavax Adjuvant contained in all Units of Customer Product(s) Disposed of by or on behalf of Customer in LMICs (excluding private markets in LMICs) during such Quarter, then Customer shall pay to Dynavax an additional amount (the “Additional Amount”) calculated in USD (United States dollars) according to the following formula: [(UMIC Price – LMIC Price) MULTIPLIED BY (W – X – Z))] PLUS [(HIC Price – LMIC Price) MULTIPLIED BY (W – X – Y)]; where:
“W” equals the total number of Doses of Dynavax Adjuvant invoiced by Dynavax to Customer at the LMIC Price in such Quarter;
“X” equals the total number of Doses of Dynavax Adjuvant contained in all Units of Customer Product(s) Disposed of by or on behalf of Customer in LMICs (excluding private markets in LMICs) in such Quarter;
“Y” equals the sum of (a) the total number of Doses of Dynavax Adjuvant contained in all Units of Customer Product(s) Disposed of by or on behalf of Customer in UMICs (excluding private markets in UMICs), and (b) the total number of Doses of Dynavax Adjuvant contained in all Units of Customer Product(s) Disposed of by or on behalf of Customer in private markets in LMICs; and
“Z” equals the sum of (a) the total number of Doses of Dynavax Adjuvant contained in all Units of Customer Product(s) Disposed of by or on behalf of Customer in HICs, and (b) the total number of Doses of Dynavax Adjuvant contained in all Units of Customer Product(s) Disposed of by or on behalf of Customer in private markets in UMICs.
B-16
The Customer shall provide to Dynavax promptly upon request all such additional information as Dynavax may reasonably request in order to determine the Additional Amount. The Additional Amount shall be due and payable within thirty (30) days of the date of receipt by Customer of an invoice from Dynavax for the Additional Amount.
B-17
|
|
(a) |
Customer shall keep, and shall cause its affiliates and Licensees to keep, complete and accurate records pertaining to the sale of Customer Product(s) in sufficient detail to permit Dynavax to confirm (i) the country in which each Unit of Customer Product(s) is Disposed of (if sales are made to a specific country); and (ii) the accuracy of all royalties paid hereunder; in each case, for at least three (3) full calendar years following the end of the calendar year to which they pertain. Dynavax shall have the right, once annually, to cause an independent, certified public accountant of international standing and reasonably acceptable to Customer to audit such records to confirm Additional Amounts, Net Sales, Units Sold, Net Sales Per Unit, Adjusted Net Sales per Unit and royalties for a period covering not more than the preceding three (3) full calendar years. No calendar year shall be subject to audit under this section more than once. Such audits may be exercised during normal business hours upon ten (10) days prior written notice to Customer. The auditor will execute a reasonable written confidentiality agreement with Customer and will disclose to Dynavax only such information as is reasonably necessary to provide Dynavax with information regarding any discrepancies between (i) amounts reported and actually paid, and (ii) amounts payable under the Supply Agreement. The auditor will send a copy of the report to Customer at the same time it is sent to Dynavax. The report sent to both Parties will include the methodology and calculations used to determine the results. If such audit reveals that Customer has failed to accurately report information pursuant to Section 6.3 or Section 6.5 or to make any Additional Amount or royalty payment (or portion thereof) when due under the Supply Agreement, then Customer, within thirty (30) days after receipt of the final audit report, shall pay to Dynavax any underpaid amounts due under the Supply Agreement, together with interest on such underpaid or late amounts calculated in accordance with Section 6.6. Dynavax shall bear the full cost of such audit unless such audit discloses an underpayment by Customer of more than 5% of the amount due for any calendar year under the Supply Agreement, in which case Customer shall bear the full cost of such audit. If such audit discloses an overpayment by Customer, then Dynavax, within thirty (30) days after receipt of the final audit report, shall pay to Customer any overpaid amounts under the Supply Agreement. |
|
|
(c) |
Dynavax shall, where permitted and as soon as reasonably practicable, notify the Customer if it (or the Dynavax CMO) receives notification from any Regulatory Authority or any other authority of an inspection which specifically relates to or impacts on the manufacturing or supply of the Dynavax Adjuvant under the Supply Agreement and will promptly provide to the Customer extracts or copies of all correspondence, reports, notices, findings and other material pertinent to such inspections received or produced by Dynavax, but only if such inspection relates to or impacts the manufacturing and/or supply of the Dynavax Adjuvant under the Supply Agreement (and the scope of such disclosure does not include the aforementioned information to the extent it specifically relates to services provided to other Dynavax clients). Furthermore, Dynavax shall keep Customer reasonably informed of any follow-on actions / remedial measures that may be required to be undertaken by Dynavax/Dynavax CMO to address any issues identified on account of the |
B-18
|
|
foregoing. Dynavax shall (and shall cause Dynavax CMO to) diligently attend to any such follow-on actions / remedial measures to ensure that the supply of the Dynavax Adjuvant under the Supply Agreement and the manufacturing and sale of the Customer Product(s) remain unaffected or minimally affected. |
|
|
(a) |
neither such Party nor any of its affiliates will, directly or indirectly through affiliates or third parties, pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving of anything of value to a public official or entity or other Person for purpose of obtaining or retaining business for or with, or directing business to, any Person, including such Party and its affiliates, nor will such Party or any of its affiliates directly or indirectly promise, offer or provide any corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to a public official or entity or any other Person; |
|
|
(b) |
neither such Party nor any of its affiliates (or any of their respective employees and contractors), in connection with the exercise of such Party’s rights or performance of such Party’s obligations under the Supply Agreement, shall cause the other Party to be in violation of Anti-Corruption Laws or Export Control Laws; |
|
|
(c) |
such Party shall immediately notify the other Party if such Party has any information that there is or is likely to be a violation of Anti-Corruption Laws or Export Control Laws in connection with the exercise of such Party’s rights or performance of such Party’s obligations under the Supply Agreement; and |
|
|
(d) |
each Party shall undertake due diligence activities appropriate to its activities under the Supply Agreement in accordance with applicable Anti-Corruption Laws and related guidance, including guidance issued by the U.S. Department of Justice Criminal Division (entitled “Evaluation of Corporate Compliance Programs”) as amended from time to time, concerning the Foreign Corrupt Practices Act (15 U.S.C. §§78dd-1, et. seq.), and issued by the U.K. Ministry of Justice concerning the UK Xxxxxxx Xxx 0000 as amended from time to time, such activities to include the conduct of appropriate due diligence in relation to third party contractors, and shall collaborate with the other Party to ensure such compliance. |
Each Party has the right, upon reasonable notice and at its sole expense, to conduct, or have conducted by an independent third party reasonably acceptable to the other Party, no more than once every three years (except for cause), a reasonable and customary audit of the other Party for the purposes of monitoring compliance with this Section 7.1, and the other Party shall, subject to compliance with Applicable Laws, provide to such Party any relevant documents reasonably requested by such Party in relation thereto. Save in respect of such an audit for cause, the auditing Party shall reimburse the audited Party for reasonable and documented out-of-pocket costs and expenses incurred by the audited Party in complying with the foregoing audit requirements.
|
7.2 |
Dynavax warrants and represents to Customer that: |
|
|
(a) |
it has the requisite power and authority to enter into the Supply Agreement and to perform its obligations hereunder; |
|
|
(b) |
as of the Effective Date neither Dynavax nor any of its officers or employees has been debarred under the U.S. Food, Drug and Cosmetic Act or any equivalent foreign law, and |
B-19
|
|
Dynavax is not involved, nor to its knowledge are any of its officers or employees involved, in any such debarment proceeding. Dynavax agrees that it will (i) not use, and (ii) require that any third-party from whom it obtains services in connection with this Supply Agreement not use, the services of any person debarred under the U.S. Food, Drug and Cosmetic Act or any equivalent foreign law; |
|
|
(c) |
as of the Effective Date, there (i) have not been any lawsuit(s) or dispute(s) and (ii) are no pending lawsuit(s) / dispute(s) (or any notice of any imminent lawsuit / dispute), in each case, against Dynavax or its affiliates, or, to Dynavax’s knowledge, Dynavax CMO, relating to the Dynavax Adjuvant; |
|
|
(d) |
to the best of Dynavax’s knowledge, the manufacturing, offering for sale, selling, exporting, importing and using of the Dynavax Adjuvant shall not infringe the intellectual property rights of any third party; |
|
|
(e) |
it and Dynavax CMO hold all authorizations, permits and licenses which are necessary to fulfil Dynavax’s obligations hereunder; |
|
|
(f) |
there are no agreements between Dynavax and any third party that conflict with the Supply Agreement. |
|
7.3 |
Customer warrants and represents to Dynavax that: |
|
|
(a) |
it has the requisite power and authority to enter into the Supply Agreement and to perform its obligations hereunder; and |
|
|
(b) |
there are no agreements between Customer and any third party that conflict with the Supply Agreement. |
B-20
|
|
|
8.3 |
Exclusions. Neither Party shall be liable to the other Party for any loss of an indirect or consequential nature including any loss of turnover, profits, business or goodwill, whether in |
B-21
|
contract, warranty, negligence, tort, strict liability or otherwise, arising out of any breach of or failure to perform any of the provisions of the Supply Agreement. |
|
8.4 |
Exclusions [***]. Notwithstanding the foregoing, nothing in the Supply Agreement shall limit the liability of either Party in respect of: |
|
|
(a) |
personal injury or death arising out of that Party’s negligence or wilful misconduct; or |
|
|
(b) |
that Party’s fraud or fraudulent misrepresentation or wilful misconduct; or |
|
|
(c) |
any other liability of such Party which cannot be limited or excluded as a matter of law; or |
|
|
(d) |
any material breach by such Party of applicable Data Protection Legislation; or |
|
|
(e) |
any material breach by such Party of applicable Anti-corruption Laws; |
|
|
(f) |
any indemnities of such Party set out under Section 8.1; or |
|
|
(g) |
any breach by such Party of confidentiality obligations set out under Section 10. |
|
8.6 |
This Section 8 shall survive termination or expiration of the Supply Agreement. |
[***] will, at its own expense, obtain and maintain [***], (a) product liability and general liability insurance providing protection in the amount of [***] and (b) workers’ compensation insurance with not less than the minimum coverage limit as required by law. Upon written request [***], [***] will furnish to [***], a copy of the certificate of insurance evidencing compliance with the provisions of this Section. The existence of such coverage will in no way limit [***] liability or obligations expressly set forth in the Supply Agreement.
B-22
|
|
(c) |
to actual and bona fide potential investors, acquirors, and other financial partners of the Receiving Party or its affiliates, and additionally in the case of Customer or its affiliates being the Receiving Party, Licensees and Authorized Third Parties; in each case, for the purpose of evaluating or carrying out an actual or potential investment or acquisition, in each case under reasonable written obligations of confidentiality and non-use; provided that the Receiving Party or its affiliate limits such disclosure to the maximum extent possible and redacts the financial terms and other provisions of the Supply Agreement that are not reasonably required to be disclosed to existing or potential investors, acquirors and other financial partners in connection with such potential investment or acquisition. |
|
10.6 |
Dynavax shall keep Customer informed of all matters relating to the manufacturing and supply of the Dynavax Adjuvant by or on behalf of Dynavax that would reasonably be expected to require an amendment to, or have an adverse impact, on the Regulatory Approval(s) / regulatory submissions for the Customer Product(s) [***]. |
|
11.1 |
Except as required by law, regulation, or any competent government authority or Regulatory Authority or in compliance with this Section 11, the Parties shall consult on and agree in writing |
B-23
|
upon the form of all press releases, publications, public announcements and public disclosures concerning the Supply Agreement or its subject matter (each a “Publication”). |
|
11.2 |
Neither Party shall use the names, logos or trademarks of the other in any Publication, advertising, promotion, or commercially-related publicity without the named Party’s prior express written consent, except as expressly provided for in this Section 11. |
|
11.3 |
Notwithstanding the foregoing, the Customer may issue a Publication regarding Customer Vaccine / Customer Product at any time provided that such Publication does not include any Confidential Information of Dynavax. |
|
12. |
Compliance with Applicable Laws |
|
12.2 |
Dynavax or Dynavax CMO, as applicable, shall manufacture, sample, test and store all Dynavax Adjuvant and provide a COA and COC in accordance with the Quality Agreement. |
Both Parties will comply with all applicable requirements of the Data Protection Legislation. Except as specifically agreed otherwise in writing between the Parties, it is hereby acknowledged and agreed that (i) no personal data will be shared between the Parties under or in connection with the Supply Agreement; and (ii) if the sharing of personal data between the Parties is strictly needed in order to perform their obligations under the Supply Agreement, a specific additional written data sharing agreement (incorporating such terms as may be required by applicable Data Protection Legislation) shall be agreed and signed by the Parties before any such sharing of personal data.
|
14.2 |
Without affecting any other right or remedy available to it, either Party may terminate the Supply Agreement with immediate effect by giving written notice to the other Party if: |
B-24
|
|
|
|
(c) |
the other Party suspends, or threatens to suspend, or ceases or threatens to cease to carry on all or a substantial part of its business; |
|
|
(d) |
the other Party or any of its directors, employees, or consultants have been found to have violated any applicable Anti-Corruption Laws. |
|
14.3 |
Customer has the right to terminate the Supply Agreement upon thirty (30) days’ written notice to Dynavax in the event: |
|
|
(a) |
there is a significant efficacy or safety concern related to the Customer Product(s) or the Dynavax Adjuvant or the Customer Vaccine that cannot be resolved to a Regulatory Authority’s satisfaction; or |
|
|
(b) |
a Regulatory Authority directs that the Customer Product(s) / Customer Vaccine / Dynavax Adjuvant be recalled or removed from the market; |
|
|
(c) |
Customer Product(s) / Customer Vaccine do not receive the necessary Regulatory Approval(s) for the development, manufacturing or commercialization; or |
|
|
(d) |
for any other reason including for convenience; |
in each case, subject to the provisions of Section 15.
B-25
|
information technology specialists), and (b) all of the Disclosing Party’s Confidential Information contained in such electronic copies of files shall remain subject to the non-use and non-disclosure provisions contained herein. |
Upon expiration or termination of the Supply Agreement for any reason: Dynavax shall, subject to prior payment by Customer of (i) all outstanding invoices for (A) Dynavax Adjuvant delivered by Dynavax; and (B) Orders for Binding Quantities not yet delivered that are Uncancellable; and (ii) in the case of Orders for Binding Quantities scheduled for delivery in 2021 and not yet delivered (and therefore not yet invoiced by Dynavax under Section 6.2(a)), an invoice issued by Dynavax for [***] percent ([***]%) of the LMIC Price of such Binding Quantities; manufacture/deliver Orders for Binding Quantities (or any portion thereof) not yet delivered.
|
15.4 |
Upon expiration or termination of the Supply Agreement for any reason, Customer and its affiliates and their Licensees shall be entitled to sell any existing Customer Product(s) in stock and also use any Remaining Stock to manufacture Customer Product(s) for sale, subject in each case to Customer’s payment and reporting obligations under Section 6 with respect to the sale of any such Customer Product(s). |
|
15.5 |
The Parties’ rights and obligations under Annex A (with regard to pricing of Doses of Dynavax Adjuvant and royalties on applicable Net Sales) and under Sections 1, 3.3, 3.6 (only so long as the Remaining Stock is available with Customer, its affiliates, their Licensees or their respective sub-contractors), 3.7, 3.9, 3.10, 3.11, 3.12, 4.1-4.5 (solely with respect to deliveries of Dynavax Adjuvant made after expiration or termination of the Supply Agreement), 4.6, 4.7, 4.8, 4.9 (solely in the event of [***]), 4.10, 4.11, 5, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7, 8, 9, 10, 11, 12.3, 12.4, 13, 15 and 17 of these Conditions shall survive expiration or termination of the Supply Agreement. |
|
16.2 |
The corresponding obligations of the other Party will be suspended to the same extent as those of the Affected Party. |
|
16.4 |
An Affected Party cannot claim relief if the Force Majeure Event is attributable to the Affected Party’s wilful act or negligence. |
|
16.5 |
The Affected Party shall notify the other Party in writing as soon as practicable after the Force Majeure Event ceases or no longer causes the Affected Party to be unable to comply with its |
B-26
|
obligations under the Supply Agreement. Following such notification, the Supply Agreement shall continue to be performed on the terms existing immediately before the occurrence of the Force Majeure Event unless mutually agreed otherwise in writing by the Parties. |
|
|
(i) |
personally, in which case the notice will be deemed to have been received at the time of delivery; |
|
|
(ii) |
by pre-paid, first-class post if the notice is being sent to an address within the country of posting, in which case the notice will be deemed to have been received at 09:00 in the country of receipt on the fifth (5th) Business Day in the country specified in the receiving Party’s address for notices after the date of posting; or |
|
|
(iii) |
by international courier service if being sent to an address outside the country of posting, in which case the notice will be deemed to have been received upon receipt by the receiving Party as documented by such international courier service. |
|
|
(b) |
A notice given under the Supply Agreement is valid if sent electronically or by fax if the paper version of notice is promptly dispatched to the receiving Party in any of the foregoing manners. |
B-27
Customer address for notice:
Biological E. Limited
Plxx Xx 000-X, Xxxx Xx 00
Xxxxxxx Xxxxx, Xxxxxxxxx 000 000
Xxxxxxxxx Xxxxx, Xxxxx
Attn: N. Xxxxxx Xxxxx
Xx. Vice President - Legal
Fax: +91- 040 -7121 6332
Tel: x00 0000 0000
With a copy to Xxxxxx Xxxxx at the address above.
Dynavax address for notice:
Dynavax Technologies Corporation
2100 Xxxxxx Xxxxxx, Xxxxx 000
Xxxxxxxxxx, XX 00000
XXX
Attn: President and Chief Operating Officer
Email: xxxxxxx@xxxxxxx.xxx
With a copy to:
Dynavax Technologies Corporation
2100 Xxxxxx Xxxxxx, Xxxxx 000
Xxxxxxxxxx, XX 00000
XXX
Attn: General Counsel
Email: xxxxx@xxxxxxx.xxx
B-28
|
between them, whether written or oral, relating to such subject matter, including the NDA, it being understood that information disclosed by a Party to the other Party pursuant to the NDA shall be subject to the non‑disclosure and non‑use obligations of the Parties under the Supply Agreement; provided that, except as set forth in Section 5.10 of the Supply Agreement, the Collaboration Agreements shall continue in full force and effect in accordance with their respective terms. |
|
17.8 |
Rights of Third Parties. This Supply Agreement is neither expressly nor impliedly made for the benefit of any party other than those executing it. |
|
17.10 |
Further Assurances. Each Party will execute, acknowledge and deliver such further instruments, and do all such other acts, as may be reasonably necessary or appropriate in order to carry out the expressly stated purposes and the clear intent of the Supply Agreement. |
|
17.11 |
Successors. This Supply Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns. |
|
17.12 |
Governing Law. The Supply Agreement, and any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with it or its subject matter or formation shall be governed by and construed in accordance with the laws of England and Wales without giving effect to any choice of law or conflict of law provisions or rules that would cause the application of the laws of any other jurisdiction. The U.N. Convention on Contracts for the International Sale of Goods (1980) is excluded and will not apply to the Supply Agreement. Nothing in the Supply Agreement shall prevent either Party from applying to a court of law for injunctive relief. |
|
|
(b) |
Arbitration. All Disputes not resolved within thirty (30) days following the written request for amicable resolution shall be submitted to the International Court of Arbitration of the International Chamber of Commerce (“ICC”) and shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce (the “Rules”) (which Rules are deemed to be incorporated by reference into the Supply Agreement). The following provisions shall apply, unless the Parties agree otherwise: |
|
|
(i) |
The arbitral tribunal shall be composed of one or more arbitrators appointed in accordance with the Rules; |
|
|
(ii) |
The seat, or legal place, of arbitration shall be London, England; |
|
|
(iii) |
The language of the arbitration shall be English; |
|
|
(iv) |
The tribunal shall draw up and submit to the Parties for signature the Terms of Reference within sixty (60) days of receiving the file; |
B-29
|
|
(v) |
The arbitration award shall be final and binding on the Parties, and judgment upon the award may be entered by any court having jurisdiction thereof; and |
|
|
(vi) |
Except as may be required by Applicable Laws, neither a Party nor an arbitrator may disclose the existence, content, or results of any arbitration hereunder without the prior written consent of both Parties. For clarity, no award or procedural order made in the arbitration shall be published, except as may be required by Applicable Laws. |
|
17.14 |
Counterparts |
The Supply Agreement may be executed in one (1) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
B-30
