ASSET PURCHASE AGREEMENT dated as of July 27, 2023 by and between AEGLEA BIOTHERAPEUTICS, INC. and IMMEDICA PHARMA AB
Exhibit 10.9
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Execution Version
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dated as of
July 27, 2023
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by and between
and
IMMEDICA PHARMA AB
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TABLE OF CONTENTS
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ARTICLE I PURCHASE PRICE |
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Section 1.1 |
Purchase Price |
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Section 1.2 |
Milestone Payments. |
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ARTICLE II PURCHASE AND SALE |
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Section 2.1 |
Acquired Assets |
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Section 2.2 |
Excluded Assets |
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Section 2.3 |
Assumption of Assumed Liabilities |
7 |
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Section 2.4 |
Excluded Liabilities |
7 |
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Section 2.5 |
Undisclosed Contracts |
9 |
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Section 2.6 |
Non-Assignable Assets |
9 |
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Section 2.7 |
Designated Buyer |
9 |
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Section 2.8 |
ADA Assay License |
10 |
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ARTICLE III CLOSING |
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Section 3.1 |
Closing |
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Section 3.2 |
Deliveries by Aeglea |
10 |
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Section 3.3 |
Deliveries by Immedica at the Closing |
10 |
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Section 3.4 |
Additional Closing Deliveries |
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Section 3.5 |
Appointment |
11 |
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ARTICLE IV REPRESENTATIONS AND WARRANTIES OF AEGLEA |
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Section 4.1 |
Organization and Good Standing |
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Section 4.2 |
Authorization of Agreement |
11 |
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Section 4.3 |
Subsidiaries |
12 |
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Section 4.4 |
Conflicts; Consents of Third Parties |
12 |
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Section 4.5 |
Acquired Assets |
12 |
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Section 4.6 |
Transferred Product Registrations. |
13 |
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Section 4.7 |
Assigned Contracts. |
13 |
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Section 4.8 |
Sufficiency of the Assets; Title to Acquired Assets |
14 |
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Section 4.9 |
Compliance with Laws; Litigation |
14 |
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Section 4.10 |
Regulatory Compliance |
14 |
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Section 4.11 |
Intellectual Property; Data Privacy and Security |
15 |
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Section 4.12 |
Taxes |
17 |
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Section 4.13 |
Employee Matters |
17 |
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Section 4.14 |
Environmental Compliance |
18 |
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Section 4.15 |
Finders Fees |
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Section 4.16 |
No Other Representations or Warranties |
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ARTICLE V REPRESENTATIONS AND WARRANTIES OF IMMEDICA |
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Section 5.1 |
Organization and Good Standing |
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Section 5.2 |
Authorization of Agreement |
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Section 5.3 |
Conflicts; Consents of Third Parties |
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ARTICLE VI COVENANTS |
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Section 6.1 |
Cooperation |
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Section 6.2 |
Confidentiality |
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Section 6.3 |
Publicity |
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Section 6.4 |
Transfer of Acquired Assets; Transfer and Maintenance of Product Registrations; Cooperation |
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Section 6.5 |
Batch Disposition |
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Section 6.6 |
Specified Patents |
21 |
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Section 6.7 |
Misallocated Assets |
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Section 6.8 |
Lien Releases |
22 |
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Section 6.9 |
Certain Matters |
22 |
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Section 6.10 |
Reimbursement |
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Section 6.11 |
Delivery of Post-Closing Correspondence |
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ARTICLE VII INDEMNIFICATION |
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Section 7.1 |
Survival |
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Section 7.2 |
Indemnification by Aeglea |
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Section 7.3 |
Indemnification by Immedica |
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Section 7.4 |
Indemnification Procedures |
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Section 7.5 |
Limitations on Indemnified Costs |
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Section 7.6 |
Sources of Recovery |
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Section 7.7 |
Exclusive Remedy |
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ARTICLE VIII TAX MATTERS |
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Section 8.1 |
Tax Matters; Cooperation |
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Section 8.2 |
Allocation of Purchase Price; Treatment of Milestone Payments |
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Section 8.3 |
Transfer Taxes |
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Section 8.4 |
Apportioned Obligations. |
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Section 8.5 |
Withholding |
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ARTICLE IX MISCELLANEOUS |
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Section 9.1 |
Expenses |
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Section 9.2 |
Governing Law |
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Section 9.3 |
Specific Performance |
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Section 9.4 |
Jurisdiction |
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Section 9.5 |
WAIVER OF JURY TRIAL |
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Section 9.6 |
Entire Agreement |
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Section 9.7 |
License Agreement |
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Section 9.8 |
Amendments and Waivers |
31 |
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Section 9.9 |
Notices |
31 |
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Section 9.10 |
Severability |
32 |
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Section 9.11 |
No Third-Party Beneficiaries |
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Section 9.12 |
Bulk Sales Laws |
32 |
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Section 9.13 |
Assignment |
32 |
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Section 9.14 |
Neutral Construction |
32 |
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Section 9.15 |
Counterparts; Effectiveness |
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This ASSET PURCHASE AGREEMENT is entered into as of July 27, 2023 (this βAgreementβ), by and between Aeglea BioTherapeutics, Inc., a corporation organized and existing under the laws of Delaware (βAegleaβ), and Immedica Pharma AB, a limited company (Aktiebolag) organized and existing under the laws of Sweden (βImmedicaβ). Each of Aeglea and Immedica are sometimes referred to herein individually as a βPartyβ and collectively as the βParties.β Capitalized terms used herein and not otherwise defined shall have the meanings set forth in Exhibit A.
W I T N E S S E T H:
WHEREAS, Aeglea has established a research, development and manufacturing program for pegzilarginase for the treatment of Arginase-1 Deficiency as well as other therapeutic, prophylactic, palliative and diagnostic uses (the βProgramβ);
WHEREAS, Immedica and Aeglea are parties to that certain License and Supply Agreement dated as of March 21, 2021, as amended by that certain Memorandum of Understanding dated July 1, 2021, that certain Memorandum of Understanding dated June 22, 2022, and that certain Amendment No. 2 to the Agreement dated March 28, 2023 (the βLicense Agreementβ), pursuant to which Aeglea licenses to Immedica certain rights in and to the Product and Aegleaβs Intellectual Property rights therein; and
WHEREAS, Xxxxxx agrees to sell to Immedica, and Immedica agrees to purchase from Aeglea, assets owned by Aeglea and related to the Product on the terms and subject to the conditions set forth herein.
NOW, THEREFORE, in consideration of the foregoing and the mutual representations, warranties, covenants and agreements contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound hereby, the Parties hereby agree as follows:
ARTICLE I
PURCHASE PRICE
Section 1.1 Purchase Price. In consideration of the conveyance to Immedica of all right, title and interest in, under and to the Acquired Assets and the other rights granted to Immedica hereunder, and subject to the terms and conditions hereof, Immedica shall pay to Aeglea:
Section 1.2 Milestone Payments.
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Milestone Event |
Milestone Payment |
Pricing and Reimbursement Approval in France of the Product that is indicated for treatment of Arginase-1 Deficiency by the applicable Governmental Authority in France, where such Product has previously received Regulatory Approval in France for the treatment of Arginase-1 Deficiency |
Reimbursement Earnout Amount for such Product in France |
Pricing and Reimbursement Approval in Germany of the Product that is indicated for treatment of Arginase-1 Deficiency by the applicable Governmental Authority in Germany, where such Product has previously received Regulatory Approval in Germany for the treatment of Arginase-1 Deficiency |
Reimbursement Earnout Amount for such Product in Germany |
Pricing and Reimbursement Approval in the United Kingdom of the Product that is indicated for treatment of Arginase-1 Deficiency by the applicable Governmental Authority in the United Kingdom, where such Product has previously received Regulatory Approval in the United Kingdom for the treatment of Arginase-1 Deficiency |
Reimbursement Earnout Amount for such Product in the United Kingdom |
Regulatory Approval of the BLA of the Product for the treatment of Arginase-1 Deficiency in the United States |
$30,000,000 |
Additional Milestone Event (as such term is defined in Schedule β1.2(a)). |
Additional Milestone Amount (as such term is defined in Schedule β1.2(a)). |
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(i) The definitions of Reimbursement Earnout Amount, Actual Reimbursement Percentage, Actual Reimbursement Price, Expected Reimbursement Price and Pricing Reimbursement Approval are stated with respect to a 2 mg vial of the Product. In the event that any of the Milestone Events set forth in the first three rows of the table set forth in this βSection 1.2 occurs with respect to a vial with a different amount of Product, the amounts in Euros and British Pounds Sterling will be proportionally adjusted, on a linear basis based on mg of Product, for purposes of calculating the Reimbursement Earnout Amount. By way of example, in the event that any of the Milestone Events set forth in the first three rows of the table set forth in this βSection 1.2 occurs with respect to a 4 mg vial of Product, then the Expected Reimbursement Price of such 4 mg vial of Product (A) with respect to France would be [*]/4 mg vial of such Product; (B) with respect to Germany would be [*]/4 mg vial of such Product; and (C) with respect to the United Kingdom would be [*]/4 mg vial of such Product, and the Reimbursement Earnout Amount for such 4 mg vial of such Product would be determined using such amounts.
(ii) βActual Reimbursement Percentageβ means, with respect to a 2 mg vial of the Product in a given country, a number equal to the quotient of (A) the Actual Reimbursement Price for such 2 mg vial of the Product received by Immedica in such country, divided by (B) the Expected Reimbursement Price for such 2 mg vial of the Product in such country. By way of examples, if the Actual Reimbursement Price for a 2 mg vial of the Product received by Immedica in France is [*], then the Actual Reimbursement Percentage for such 2 mg vial of the Product in France is [*] or 93%; and if the Actual Reimbursement Price for a 2 mg vial of the Product received by Immedica in Germany is [*], then the Actual Reimbursement Percentage for such 2 mg vial of the Product is [*] or 87%.
(iii) βActual Reimbursement Priceβ means, with respect to a given country, the price reimbursed by the applicable Governmental Authority, net of any mandatory rebates, for a 2 mg vial of the
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Product in such country pursuant to the Pricing and Reimbursement Approval for such 2 mg vial of the Product in such country, where such reimbursed price may be the listed price or a discounted price, net of any mandatory rebates, of such 2 mg vial of the Product that is agreed and approved between Immedica and such applicable Governmental Authority.
(iv) βExpected Reimbursement Priceβ means, (A) with respect to France, [*]/2 mg vial of the Product; (B) with respect to Germany, [*]/2 mg vial of the Product; and (C) with respect to the United Kingdom, [*]/2 mg vial of the Product.
(v) [Reserved].
(vi) βPricing and Reimbursement Approvalβ means, with respect to a 2 mg vial of the Product in a given country, following Regulatory Approval of such 2 mg vial of the Product for the treatment of Arginase-1 Deficiency in such country by the applicable Regulatory Authority in such country, the later of (A) the approval, agreement, determination or decision by (1) the Ministries of Health and Social Security in France as published in the Journal Officiel, (2) the National Institute for Health and Care Excellence in the United Kingdom as set forth in the applicable commercial access agreement and (3) Spitzenverband der Gesetzlichen Krankenkassen (GKV-Spitzenverband) in Germany as published in the Xxxxx Taxe establishing a price for such 2 mg vial of the Product that can be legally charged to consumers, if required or desirable, in such country in connection with the broad commercialization of such 2 mg vial of the Product for the treatment of Arginase-1 Deficiency in such country; and (B) the approval, agreement, determination or decision by the foregoing applicable Governmental Authority establishing the level of reimbursement for such 2 mg vial of the Product that will be reimbursed by such Governmental Authority, if required or desirable, in such country in connection with the broad commercialization of such 2 mg vial of the Product for the treatment of Arginase-1 Deficiency in such country.
(vii) [Reserved].
(viii) [Reserved].
(ix) [Reserved].
(x) βReimbursement Earnout Amountβ means, with respect to a 2 mg vial of the Product in a given country: (A) if the Actual Reimbursement Percentage of such 2 mg vial of the Product in such country is equal to 100% or more, $10,000,000, (B) if the Actual Reimbursement Percentage of such 2 mg vial of the Product in such country is less than 80%, zero, and (C) if the Actual Reimbursement Percentage of such 2 mg vial of the Product in such country is 80% or more but less than 100%, an amount equal to the sum of (i) $3,333,333 and (ii) the product of (A)(x) the Actual Reimbursement Percentage for such 2 mg vial of the Product in such country minus 80% divided by (y) 20% multiplied by (B) $6,666,666; or, in the case of the foregoing clause (C), the formula expressed as follows:
$3,333,333 |
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Actual Reimbursement Percentage minus 80% |
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$6,666,666 |
20% |
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(xi) [Reserved].
(xii) [Reserved].
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ARTICLE II
PURCHASE AND SALE
Section 2.1 Acquired Assets.
(i) the assets listed on Schedule β2.1(b)(i)(D);
(ii) the Assigned Contracts;
(iii) all Biological Materials;
(iv) all Inventory;
(v) all Product Registrations that are (A) used in or held for use in the Program or in connection with the Product or (B) listed on Schedule β2.1(b)(v) (collectively, the βTransferred Product Registrationsβ); provided that Aeglea shall be entitled to retain copies of the Transferred Product Registrations solely to the extent necessary to comply with applicable Law and its internal document retention policies, subject to Aegleaβs nonuse and confidentiality obligations set forth in βSection 6.2;
(vi) all Documents primarily related to the Program or Product or that are otherwise related to the Product or Program and reasonably necessary and useful to the Product or the Program (collectively, the βTransferred Documentsβ), including all attorney-client privilege and attorney work-product protection and all Documents subject to the attorney-client privilege or work-product protection in each case that relate to the Product or the Program; provided that the Transferred Documents shall exclude all (w) personnel files for any current or former directors, officers, employees, independent contractors or consultants (collectively, βAeglea Service Providersβ), (x) Documents relating to Spyre Therapeutics, Inc. and its businesses or assets, as well as the transactions (the βSpyre Transactionsβ) contemplated by that certain Agreement and Plan of Merger, dated June 22, 2023, by and between Aeglea, Spyre Therapeutics, Inc., Aspen Merger Sub I, Inc. and Sequoia Merger Sub II, LLC (collectively, the βSpyre Documentsβ), (y) Documents subject to the attorney-client privilege or work-product protection relating solely to the License Agreement (and not the Product or the Program), and (z) Documents relating to the determination by Aeglea or any of its Subsidiaries with respect to the wind-down or discontinuation of all or a portion of the Program or any study related thereto; and provided, further, that Aeglea shall be entitled to (1) redact information from any Transferred Document that if in a separate document would fall within the foregoing exceptions or that relates exclusively to something other than the Product or the Program, and (2) retain copies of the foregoing (A) to the extent necessary to comply with applicable Law and its internal document retention policies and (B) to the extent any Transferred Document relates to Excluded Assets or Excluded Liabilities, in each case, subject to Xxxxxxβs nonuse and confidentiality obligations set forth in βSection 6.2;
(vii) all claims, causes of action (including the right to sue for past infringement or misappropriation), defenses, rights of recovery and rights of set-off against third parties and all credits (including all guarantees, warranties, indemnities and similar rights) in favor of Aeglea or any of its
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Subsidiaries, in each case to the extent relating to, arising out of or in connection with the Product, the Program, the Acquired Assets or the Assumed Liabilities; and
(viii) all other assets, properties and rights of a type not expressly covered in this βSection 2.1(b) that are exclusively related to, exclusively used in or exclusively held for use in Program or in connection with the Product.
Section 2.2 Excluded Assets.
(i) all cash and cash equivalents, securities, negotiable instruments, accounts receivable, notes and other amounts receivable of Aeglea or its Subsidiaries;
(ii) any rights to Tax refunds, credits, deductions, allowances or other Tax benefits of Aeglea or its Subsidiaries;
(iii) the company seal, minute books, charter documents, stock or equity record books and such other books and records as pertain to the organization, existence or capitalization of Aeglea and its Subsidiaries, as well as any other records or materials relating to Aeglea or its Subsidiaries that are exclusively related to the Excluded Assets or are not related to the Acquired Assets, the Program or the Product;
(iv) the shares of capital stock, partnership interests, membership interests or other equity interests of any Person (including Aeglea or any of its Subsidiaries);
(v) other than the Assigned Intellectual Property and subject to the terms and conditions of βSection 6.6 and the Specified Patent License Agreement, all right, title and interest in and to all Intellectual Property and all other intangible property of Aeglea;
(vi) all equipment and tangible personal property of Aeglea or any of its Subsidiaries;
(vii) all real property owned or leased by Aeglea or any of its Subsidiaries;
(viii) all Contracts listed on Schedule β2.2(b)(viii);
(ix) all rights which accrue or will accrue to Aeglea or any of its Subsidiaries under this Agreement;
(x) (A) all attorney-client privilege and attorney work-product protection of Aeglea or its Subsidiaries, (B) all Documents subject to the attorney-client privilege or work-product protection, in the case of the foregoing clauses (A) and (B), solely to the extent not primarily related to the Program or Product or that are otherwise not related to the Product or Program and not reasonably necessary and useful to the Product or the Program, (C) all Documents subject to the attorney-client privilege or work-product protection maintained by Aeglea or its Subsidiaries in connection with the Transaction, the License Agreement or the Spyre Transaction and (D) all Documents (including those subject to attorney-client
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privilege or work-product protection) that (i) are personnel files for Aeglea Service Providers, (ii) are Spyre Documents or (iii) relate to the determination by Aeglea or any of its Subsidiaries with respect to the wind-down or discontinuation of all or a portion of the Program or any study related thereto;
(xi) Tax Returns of Aeglea and its Subsidiaries (other than Tax Returns or any portion thereof solely relating to any Acquired Asset);
(xii) all current and prior insurance policies of Aeglea and its Subsidiaries and all rights of any nature with respect thereto, including all insurance recoveries thereunder and rights to assert claims with respect to any such insurance recoveries;
(xiii) all assets with respect to any employee benefit plans, agreements or arrangements contributed to, sponsored, maintained or entered into by Aeglea or its Subsidiaries or otherwise relating to any Aeglea Service Providers;
(xiv) the ADA Assays; and
(xv) all other assets, properties, contractual rights, goodwill and other intangible assets, rights and claims of Aeglea and its Subsidiaries not included in the Acquired Assets.
Section 2.3 Assumption of Assumed Liabilities.
(i) all Liabilities of Aeglea arising under or in connection with the Assigned Contracts from and after the Closing, excluding for clarity the Excluded Liabilities set forth in Sections β2.4(b)(iv) and β2.4(b)(v) below, but including the amounts as set forth in Schedule β2.3(b)(i);
(ii) all Liabilities of Aeglea arising out of or relating to actions by Immedica or its Subsidiaries commenced after the Closing, irrespective of the legal theory asserted, arising from the administration, manufacture, advertising, marketing, distribution, sale or use of the Product or conduct of the Program during the period of time on or after the Closing;
(iii) without duplication of the other provisions of this βSection 2.3(b), all Liabilities arising out of or in connection with an event first occurring at any time from and after the Closing to the extent relating to the Program or Product, or the use, ownership or operation of the Acquired Assets by Immedica or its Subsidiaries from and after the Closing, other than Liabilities of Aeglea or any of its Subsidiaries arising out of a breach or termination of this Agreement by Aeglea or any of its Subsidiaries.
Section 2.4 Excluded Liabilities.
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(i) all Liabilities to the extent not related to the Program, Product or the Acquired Assets;
(ii) all Liabilities relating to or arising out of the Excluded Assets;
(iii) (A) all Liabilities of Aeglea, its Affiliates or any consolidated, affiliated, combined or unitary group of which Aeglea or any of its Affiliates is or has been a member, for Taxes and (B) all Liabilities for Taxes with respect to the Acquired Assets for taxable periods ending on or prior to the Closing Date; provided that any Transfer Taxes incurred in connection with the Transaction and Apportioned Obligations shall be paid in the manner set forth in Article βVIII;
(iv) all Liabilities relating to the Assigned Contracts to the extent such Liabilities (A) arise before the Closing, including, for the avoidance of doubt, any amounts owed under any Assigned Contract prior to the Closing pursuant to the terms thereof, regardless of whether the work to be performed, services to be rendered or goods to be provided in exchange for such amounts owed are to be provided before or after payment therefor or before or after the Closing, and regardless of whether an invoice for any such payment is rendered before or after the Closing; provided that the amounts listed on Schedule β2.3(b)(i) under the column βExpense to be Assumed by Immedicaβ shall be assumed by Immedica, (B) arise from or relate to any breach by Aeglea or any of its Subsidiaries of any provision of any of such Assigned Contract or (C) arise from or relate to any action or inaction by Aeglea or any of its Subsidiaries in connection with any such Assigned Contract;
(v) all Liabilities under any Contract that is not an Assigned Contract and, subject to βSection 2.6, all Liabilities under any Assigned Contract that is not validly and effectively assigned to Immedica pursuant to this Agreement or any other Instrument;
(vi) all Liabilities, whether arising prior to, upon or following the Closing, with respect to any Aeglea Service Providers, including, without limitation, all Liabilities (A) under or relating to any employee benefit plan, contract, program, fund or arrangement and any trust, escrow or similar agreement related thereto, whether or not funded, in respect of any Aeglea Service Provider or with respect to which Aeglea or any of its Affiliates has made or is required to make payments, transfers or contributions, or any management, employment, severance, change in control, noncompete, confidentiality, offer letter, retention, incentive or similar Contract, and (B) the matters set forth on Schedule β2.4(b)(vi);
(vii) all Liabilities of Aeglea or any of its Affiliates in respect of Indebtedness;
(viii) all Liabilities in respect of any pending Legal Proceedings and any Legal Proceedings initiated after the Closing arising out of or relating to the administration, development, manufacture, advertising, marketing, distribution, sale or use of the Product or conduct of the Program prior to the Closing;
(ix) all Expenses of Aeglea or any of its Subsidiaries payable to Third Parties, including to any outside professionals (including any broker, finder, agent, investment banker, legal, accounting or tax adviser), incurred by Aeglea or any of its Subsidiaries before, on or after the Closing, in connection with the authorization, preparation, negotiation, execution and performance of this Agreement or the other
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Instruments, or the process of selling the Acquired Assets, including any investment banking or brokerage fees, findersβ fees or commissions; and
(x) all other Liabilities arising out of or relating to the Product, the Program or the Acquired Assets, to the extent such Liabilities relate to the period of time prior to Closing.
Section 2.5 Undisclosed Contracts. If any Program Contract was not set forth on Schedule β2.1(b)(i) or β2.2(b)(viii) and is identified following the Closing, Aeglea shall promptly notify Immedica in writing giving sufficient disclosure of such Program Contract and provide Immedica with a copy thereof, in which case Immedica shall thereafter be entitled to deem such Program Contract an βAssigned Contractβ and the provisions of this Agreement (including βSection 2.6) shall apply to such Program Contract as though it were an Assigned Contract, and Aeglea and Immedica shall take such action reasonably requested by Immedica (and consistent with the other provisions of this Agreement (including βSection 2.6)) to assign such Program Contract to Immedica. Neither Aeglea nor any of its Subsidiaries shall voluntarily terminate any such nondisclosed Program Contract prior to providing Immedica with written notice of the intent to terminate and giving Immedica a reasonable period of time to review such Program Contract and determine whether to exercise its right to treat such Program Contract as an βAssigned Contract.β
Section 2.6 Non-Assignable Assets. Notwithstanding anything to the contrary in this Agreement, nothing in this Agreement or the consummation of the Transaction shall be construed as an attempt or agreement to assign any Acquired Asset, including any Contract, Permit, certificate, approval, authorization or other right, which by its terms or by Law is non-assignable without the consent of a Third Party or a Governmental Authority or is terminable or cancelable by a Third Party or a Governmental Authority in the event of an assignment (any such Acquired Asset, a βNonβassignable Assetβ) unless and until such consent shall have been obtained. Aeglea shall and shall cause its Subsidiaries to use all commercially reasonable efforts to obtain any such consents with respect to the Acquired Assets, including all Non-assignable Assets, and including all consents set forth on Schedule β4.4(a), as promptly as practicable, and shall cooperate as reasonably requested by Immedica in any efforts made by Immedica or any of its Affiliates to obtain such consent. If any such consent or approval is not obtained, Aeglea shall, and shall cause its Subsidiaries to, provide to Immedica the benefits of such Non-assignable Asset in accordance with this Agreement and shall enforce, or cause its Subsidiaries to enforce, at the request of and for the benefit of Immedica, any rights of Aeglea or its Subsidiaries arising thereunder, including the right to seek any available remedies or to terminate in accordance with the terms thereof, in each case at Immedicaβs cost and expense. Aeglea shall and shall cause its Subsidiaries to promptly pay to Immedica when received all monies received by Aeglea or any of its Affiliates under any such Non-assignable Asset or any claim, right or benefit arising thereunder, except to the extent the same represents an Excluded Asset. As a condition to Aeglea providing Immedica with the benefits of any Non-assignable Asset, Immedica shall perform, in the name or on behalf of Aeglea or its applicable Subsidiary, all obligations of Aeglea or its applicable Subsidiary and shall indemnify Aeglea or its applicable Subsidiary for any Liabilities first arising thereunder following the Closing, except to the extent such Liabilities relate to the gross negligence or willful misconduct of Aeglea or any Aeglea Indemnified Party or the failure of Aeglea or any Aeglea Indemnified Party to follow the reasonable written (email being sufficient) instructions of Immedica or any of its Subsidiaries with respect to such Non-assignable Asset. To the extent that, in connection with obtaining a Third Partyβs consent under any Non-assignable Asset, one or more of the Parties enter into an agreement with such Third Party that provides for an allocation of liability among the Parties with respect to such Non-assignable Asset that is inconsistent with the terms of this Agreement, the Parties agree that, as among themselves, the provisions of this Agreement shall control.
Section 2.7 Designated Buyer. Notwithstanding anything to the contrary contained in this Agreement, Immedica may elect to have any or all of the Acquired Assets sold, assigned, conveyed, transferred or delivered to, or any of the Assumed Liabilities assumed by, one or more of its Subsidiaries, in each case as set forth in the Instruments to be delivered at Closing; provided, however, that no such sale, assignment, conveyance, transfer
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or delivery shall (a) relieve Immedica of any of its obligations to Aeglea hereunder with respect to the Assumed Liabilities or (b) otherwise increase or expand the obligations of Aeglea hereunder.
Section 2.8 ADA Assay License. Aeglea and its Subsidiaries hereby grant to Immedica and its Affiliates a royalty-free, fully paid-up, worldwide, fully transferable, irrevocable, perpetual, non-exclusive, sublicensable (including the right to sublicense through multiple tiers) license under their respective rights in and to the ADA Assays to use and otherwise Exploit the ADA Assays for any and all purposes.
ARTICLE III
CLOSING
Section 3.1 Closing. The closing of the Transaction (the βClosingβ) shall take place on the date hereof (the βClosing Dateβ) remotely by exchange of documents and signatures (or their electronic counterparts), simultaneously with the execution and delivery of this Agreement.
Section 3.2 Deliveries by Aeglea.
(i) an assignment and assumption agreement and bill of sale, in a form reasonably agreed among the Parties (the βAssignment and Assumption and Bill of Saleβ), executed by a duly authorized officer of Aeglea;
(ii) the agreements listed on Schedule β3.2(b); and
(iii) the IP Assignment Agreement, executed by a duly authorized officer of Aeglea.
(iv) [Reserved].
Section 3.3 Deliveries by Immedica at the Closing. At the Closing, Immedica shall deliver, or cause to be delivered, to Aeglea, as applicable, the following:
Section 3.4 Additional Closing Deliveries. From time to time following the Closing, at the reasonable request of Aeglea or Immedica, such other Party shall execute, acknowledge and deliver all such further
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conveyances, notices, assumptions, releases and acquittances and such other instruments, and shall take such further actions, as may be necessary to assure (a) to Immedica and its successors and assigns, all of the properties, rights, titles, interests, estates, remedies, powers and privileges intended to be conveyed to Immedica under this Agreement and the other Instruments, and (b) to the Parties and their respective Affiliates, and their respective successors and assigns, the assumption of the Liabilities intended to be assumed by Immedica under this Agreement and the other Instruments, and to otherwise make effective the Transaction.
Section 3.5 Appointment. Aeglea hereby constitutes and appoints, effective as of the Closing, Immedica and its successors and assigns as the true and lawful attorney of Aeglea with full power of substitution in the name of Immedica, or in the name of Aeglea but for the benefit of Immedica, to collect for the account of Immedica any items of Acquired Assets. Immedica shall be entitled to retain for its own account any amounts collected pursuant to the foregoing powers, including any amounts payable as interest in respect thereof and shall promptly remit to Aeglea without any set-off any amounts collected that are not Acquired Assets.
ARTICLE IV
Β
REPRESENTATIONS AND WARRANTIES OF Aeglea
Aeglea hereby represents and warrants to Immedica as of the Closing Date as follows:
Section 4.1 Organization and Good Standing. Aeglea is an entity duly organized, validly existing and in good standing under the applicable Laws of the state of its organization and has all requisite corporate or other similar organizational powers required to carry on its business as now conducted. Aeglea is duly qualified to do business as a foreign entity and, to the extent legally applicable, in good standing as a foreign entity in each jurisdiction where such qualification is necessary, except for those jurisdictions where failure to be so qualified or in good standing would not, individually or in the aggregate, reasonably be expected to be material to the Acquired Assets, the Product (which term βProduct,β solely for purposes of this Article βIV, shall refer to the Product in accordance with good manufacturing practices, as defined under the applicable sections of the United States Code of Federal Regulations, and the specifications contained in the Transferred Product Registrations) or the Program (which term βProgram,β solely for purposes of this Article βIV, shall refer to the research, development and manufacturing program for pegzilarginase solely with respect to the treatment of Arginase-1 Deficiency), or materially impede or materially delay the consummation by Aeglea of the Transactions or the performance of its obligations under this Agreement or any Instrument to which it is a party.
Section 4.2 Authorization of Agreement. Aeglea and each of its applicable Subsidiaries has all requisite power and authority to execute and deliver this Agreement and each other agreement, document or instrument contemplated by this Agreement to which it is a party (collectively, the βInstrumentsβ), to perform its respective obligations hereunder and thereunder and to consummate the Transaction and the other transactions contemplated hereby and thereby. The execution, delivery and performance by Aeglea and each of its applicable Subsidiaries of each of this Agreement and each other Instrument and the consummation of the Transaction and the other transactions contemplated hereby and thereby have been duly authorized and approved by all requisite corporate or similar action on the part of Aeglea and each of its applicable Subsidiaries. Each of the Instruments has been, or will be at or prior to the Closing, duly and validly executed and delivered by Aeglea and each of its Subsidiaries party thereto and (assuming the due authorization, execution and delivery by the other parties thereto) each of the Instruments, when so executed and delivered, will constitute the legal, valid and binding obligations of Aeglea and each such Subsidiary, enforceable against it in accordance with its terms, subject to the effect of any applicable Laws relating to bankruptcy, reorganization, insolvency, moratorium, fraudulent conveyance or preferential transfers, or similar Laws relating to or affecting creditorsβ rights generally and subject, as to enforceability, to the effect of general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at Law).
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Section 4.3 Subsidiaries. Each Subsidiary of Aeglea which has title to any Acquired Assets is duly organized, validly existing and in good standing under the laws of its jurisdiction of organization and has all requisite corporate or similar power and authority to carry on its portion of the Program as currently conducted and is duly qualified to do business and is in good standing as a foreign corporation or other entity in each jurisdiction where the ownership or operation of the Acquired Assets or the conduct of the Program requires such qualification, except for failures to be so duly organized, validly existing, qualified or in good standing that would not, individually or in the aggregate, be material to the Acquired Assets, the Product or the Program or materially impede or materially delay the consummation by such Subsidiary of the Transactions or the performance of its obligations under this Agreement or any Instrument to which it is a party.
Section 4.4 Conflicts; Consents of Third Parties.
Section 4.5 Acquired Assets.
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Section 4.6 Transferred Product Registrations.
Section 4.7 Assigned Contracts.
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Section 4.8 Sufficiency of the Assets; Title to Acquired Assets.
Section 4.9 Compliance with Laws; Litigation.
Section 4.10 Regulatory Compliance.
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Section 4.11 Intellectual Property; Data Privacy and Security.
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Section 4.12 Taxes.
Section 4.13 Employee Matters.
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Section 4.14 Environmental Compliance. Except as to matters that would not reasonably be expected to be material to the Program, the Acquired Assets or the Product:
Section 4.15 Finders Fees. There is no investment banker, broker, finder or other intermediary which has been retained by or is authorized to act on behalf of Aeglea or any of its Affiliates who might be entitled to any fee or commission in connection with the transactions contemplated by this Agreement.
Section 4.16 No Other Representations or Warranties. Except for the representations and warranties contained in this Article βIV and the representations and warranties contained in any other Instrument, Immedica acknowledges that neither Aeglea nor any other Person on behalf of Aeglea has made, and Immedica has not relied upon, any representation or warranty, whether express or implied, with respect to the Program, Product, Acquired Assets, Aeglea or its Subsidiaries, or Aegleaβs or its Subsidiariesβ businesses, affairs, assets, Liabilities, financial condition, results of operations, future operating or financial results, estimates, projections, forecasts, plans or prospects (including the reasonableness of the assumptions underlying such estimates, projections, forecasts, plans or prospects) or with respect to the accuracy or completeness of any other information provided or made available to Immedica by or on behalf of Aeglea in connection with the Transaction.
ARTICLE V
Β
REPRESENTATIONS AND WARRANTIES OF IMMEDICA
Immedica hereby represents and warrants to Aeglea as of the Closing Date as follows:
Section 5.1 Organization and Good Standing. Immedica is an entity duly organized, validly existing and, to the extent legally applicable, in good standing under the applicable Laws of the country of its organization and has all requisite corporate or other similar organizational powers required to carry on its business as now conducted. Immedica is duly qualified to do business as a foreign entity and, to the extent legally applicable,
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in good standing as a foreign entity in each jurisdiction where such qualification is necessary, except for those jurisdictions where the failure to be so qualified or in good standing would not, individually or in the aggregate, reasonably be expected to materially impede or materially delay the consummation by Immedica of the Transactions or the performance of its obligations under this Agreement or any Instrument to which it is a party.
Section 5.2 Authorization of Agreement. Immedica has all requisite power and authority to execute and deliver this Agreement and each Instrument to which it is a party, to perform its respective obligations hereunder and thereunder and to consummate the Transaction and the other transactions contemplated hereby and thereby. The execution, delivery and performance by Immedica of each of this Agreement and each other Instrument to which it is a party and the consummation of the Transaction and the other transactions contemplated hereby and thereby have been duly authorized and approved by all requisite corporate or similar action on the part of Immedica. Each of the Instruments to which Immedica is a party has been, or will be at or prior to the Closing, duly and validly executed and delivered by Immedica and (assuming the due authorization, execution and delivery by the other parties thereto) each of such Instruments, when so executed and delivered, will constitute the legal, valid and binding obligations of Immedica, enforceable against it in accordance with its terms, subject to the effect of any applicable Laws relating to bankruptcy, reorganization, insolvency, moratorium, fraudulent conveyance or preferential transfers, or similar Laws relating to or affecting creditorsβ rights generally and subject, as to enforceability, to the effect of general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at Law).
Section 5.3 Conflicts; Consents of Third Parties. None of the execution and delivery of this Agreement or the Instruments to which Immedica is a party by Immedica, or the consummation of the Transaction or the other transactions contemplated hereby and thereby, will conflict with, or result in any violation of, or constitute a breach of, or conflict with or constitute a default (with or without notice or lapse of time, or both) under any provision of, or require any consent or other action by any Person under, or give rise to any right of termination, cancellation or acceleration under: (i) the certificate of incorporation and by-laws or comparable organizational documents of Immedica; (ii) any Order of any Governmental Authority applicable to Immedica; or (iii) any applicable Law, except, in the case of clauses (ii) and (iii) above, where such conflict, violation or default would not reasonably be expected to materially impede or materially delay the consummation by Immedica of the Transactions or the performance of its obligations under this Agreement or any Instrument to which it is a party.
ARTICLE VI
Β
COVENANTS
Section 6.1 Cooperation. Each of the Parties shall use commercially reasonable efforts to take, or cause to be taken, all actions and do, or cause to be done, all things necessary, proper or advisable to, in the most expeditious manner practicable, carry out the intent of this Agreement.
Section 6.2 Confidentiality. For a period of ten (10) years from and after the Closing Date, each Party shall not, and shall cause its Affiliates and Representatives not to, directly or indirectly, disclose, reveal, divulge or communicate to any Person other than the other Party or any of their respective Affiliates or Representatives, or, subject to the provisos set forth herein, use or otherwise exploit for the benefit of any Person other than the other Party or any of their respective Affiliates or Representatives, any Confidential Information of the other Party without the prior written consent of such other Party; provided, that, with respect to any Confidential Information that constitutes a trade secret under applicable Law, the obligations under this βSection 6.2 shall remain in effect until such Confidential Information is no longer maintained as a trade secret under applicable Law. Neither Party shall have any obligation to keep confidential any Confidential Information if and to the extent disclosure thereof is specifically required by applicable Law; provided, that in the event disclosure is required by applicable Law, the disclosing Party shall, to the extent permissible under applicable Law, notify the other Party of such requirement prior to making any disclosure so that the other Party may seek an appropriate protective order. For
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purposes of this Agreement, βConfidential Informationβ means all confidential and proprietary information of such Party; provided, that Confidential Information of a Party shall not include, and there shall be no obligation hereunder with respect to, information that (i) is generally available to the public on the date of this Agreement, (ii) becomes generally available to the public other than as a result of a disclosure by the receiving Party or any of its Affiliates or Representatives in breach of this βSection 6.2, (iii) is or becomes available to the receiving Party or any of its respective Affiliates from a source that is not known, after reasonable inquiry, by such Person to be bound by an obligation of confidentiality (provided that the provisions of this clause (iii) shall only apply to Confidential Information relating to the Acquired Assets and Assumed Liabilities to the extent that such information first becomes available after the Closing) or (iv) is independently developed by the receiving Party or any of its respective Affiliates after Closing without the use of, or reference to, the disclosing Partyβs Confidential Information. For clarity, from and after Closing, Confidential Information relating to the Acquired Assets and Assumed Liabilities shall be the Confidential Information of Immedica, and Confidential Information relating to the Excluded Assets and Excluded Liabilities shall remain the Confidential Information of Aeglea. Notwithstanding anything in the foregoing to the contrary, nothing shall prevent a Party from disclosing Confidential Information that is reasonably required to be disclosed in connection with the enforcement of this Agreement or any other Instrument.
Section 6.3 Publicity. Neither Party nor their respective Affiliates shall issue any press release or public announcement concerning this Agreement or the Transaction or make any other public disclosure containing the terms of this Agreement without obtaining the prior written approval of the other Party (not to be unreasonably withheld, conditioned or delayed) unless, in the judgment of the disclosing Party, disclosure is otherwise required by applicable Law; provided, however, that if disclosure is required by applicable Law, the Parties shall, to the extent reasonably possible, provide the other Party with prompt notice of such requirements prior to making any disclosure and confer with the other Party concerning the timing and content of such required public statement before the same is made; provided, further, that Immedica may provide general information regarding this Agreement, the other Instruments and the transactions contemplated hereby and thereby to its existing or prospective investors on a confidential basis without consulting with or obtaining the consent of Aeglea. Notwithstanding the foregoing, the Parties agree that (a) Immedica may issue a press release regarding the Transaction in the form mutually agreed by the Parties prior to the date hereof, and (b) Aeglea may file a Form 8-K with the United States Securities and Exchange Commission regarding the Transaction, which 8-K may include a copy of this Agreement, provided that Immedica shall be afforded a reasonable opportunity to review and comment on such 8-K prior to the filing thereof, which comments Aeglea shall consider in good faith.
Section 6.4 Transfer of Acquired Assets; Transfer and Maintenance of Product Registrations; Cooperation.
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Section 6.5 Batch Disposition. Prior to the later of (i) thirty (30) days after Closing and (ii) ten (10) days following the date on which Aeglea or its applicable Affiliate receives analysis results and batch documentation reasonably necessary to affect the following batch release, Aeglea shall, or shall cause one or more of its Subsidiaries to, perform batch disposition and release of 2 mg vials of batch number B23020012 of the Inventory produced by Aeglea or one or more of its Subsidiaries to Immedica for secondary packaging.
Section 6.6 Specified Patents.
Section 6.7 Misallocated Assets. If, following the Closing, any right, property or asset not forming part of the Acquired Assets is found to have been transferred to Immedica in error, either directly or indirectly, Immedica shall (a) transfer at no cost to Aeglea, such right, property or asset (and any related Liability) as soon as practicable to one or more of Aeglea and its Subsidiaries designated by Aeglea and (b) prior to such transfer, ensure that Immedica shall, where permitted by the terms on which it has the right to such asset, hold the asset (or part
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thereof), and any monies, goods or other benefits arising after the Closing by virtue of it, as agent of and trustee for Aeglea and its Subsidiaries and allow Aeglea and its Subsidiaries from and after the Closing to have full enjoyment and use of such asset and Aeglea and its Subsidiaries shall bear all burdens relating to such asset. If, following the Closing, any right, property or asset forming part of the Acquired Assets is found to have been retained by Aeglea in error, either directly or indirectly, Aeglea shall (i) transfer, at no cost to Immedica, such right, property or asset (and any related Liability) as soon as practicable to Immedica and (ii) prior to such transfer, ensure that Aeglea shall where permitted by the terms on which Aeglea or its applicable Affiliate has the right to such asset, hold the asset (or part thereof), and any monies, goods or other benefits arising after the Closing by virtue of it, as agent of and trustee for Immedica and allow Immedica from and after the Closing to have full enjoyment and use of such asset and Immedica shall bear all burdens relating to such asset. For the avoidance of doubt, the Parties understand and agree that (x) the Excluded Assets are not intended to, and shall not, be transferred to Immedica and Aeglea shall retain such rights, properties and assets, and (y) the Acquired Assets are intended to, and shall, be transferred to Immedica and Immedica shall acquire such rights, properties and assets.
Section 6.8 Lien Releases. Aeglea shall provide, and shall cause its Subsidiaries to provide, all assistance reasonably requested by Immedica in connection with obtaining, effective at or as soon as possible following the Closing, appropriate termination statements under the Uniform Commercial Code (or equivalent documents pursuant to applicable Law), payoff letters and other instruments, in connection with the release of security interests or other Liens against or relating to any of the Acquired Assets.
Section 6.9 Certain Matters.
Section 6.10 Reimbursement. Following the Closing, promptly following the earlier of (a) receipt by Immedica of a positive opinion from the European Medicines Agencyβs Committee for Medicinal Products for Human Use recommending the granting of a marketing authorization with respect to the Product and (b) the date of vial thaw by the applicable manufacturer to Immedica of the first drug substance batch of the Product initiated by Immedica pursuant to the Fuji Scope of Work, Immedica shall, within thirty (30) days thereof, pay an amount equal to the Fuji Credit to Aeglea in cash by wire transfer of immediately available funds in accordance with written instructions furnished to Immedica by Aeglea.
Section 6.11 Delivery of Post-Closing Correspondence. Following the Closing, Aeglea shall promptly forward to Immedica any mail (including electronic mail) and other correspondence that Aeglea or any of its Subsidiaries receives after the Closing Date that is intended for the owner of the Acquired Assets, Assumed Liabilities, the Program or the Product. Following the Closing, Immedica shall promptly forward to Aeglea any mail (including electronic mail) and other correspondence that Immedica or any of its Subsidiaries receives after the Closing Date that relates to the Excluded Assets, the Excluded Liabilities or is otherwise intended for the owner of the Excluded Assets.
ARTICLE VII
Β
INDEMNIFICATION
Section 7.1 Survival. The representations and warranties of the Parties contained in this Agreement or in any certificate or other writing delivered pursuant hereto shall survive until 5:00 p.m. Eastern Time on the twelve (12)-month anniversary of the Closing Date; provided, that (a) the representations and warranties of Aeglea contained in Sections β4.1, β4.2, β4.3, ββ4.4(a)(i), β4.8(b) and β4.15 and the first two sentences of βSection 4.5(a) (collectively, the βFundamental Representationsβ) shall survive the Closing until 5:00 p.m. Eastern Time on May 22, 2026 and (b) the representations and warranties of Aeglea contained in βSection 4.11 (the βIP Representationsβ)
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and the representations and warranties of Aeglea contained in βSection 4.8(a) shall survive the Closing until 5:00 p.m. Eastern Time on May 22, 2026 (as applicable, the βSurvival Periodβ). The covenants and agreements of the Parties contained in this Agreement or in any certificate or other writing delivered pursuant hereto shall survive indefinitely or for such shorter period explicitly specified therein. Upon termination and expiration of any representation and warranty, covenant or agreement for the purposes of indemnification, all indemnification obligations with respect to such representation and warranty, covenant or agreement shall likewise terminate and expire, except to the extent that the Person to be indemnified pursuant to this Article βVII (the βIndemnified Partyβ) shall have (in good faith) given written notice a claim to the indemnifying party pursuant to this Article βVII (the βIndemnifying Partyβ) before termination of the applicable Survival Period, in which event the representation and warranty, covenant or agreement alleged in the claim to have been breached and any associated right to indemnification shall continue until such claim for indemnification is resolved. For the avoidance of doubt, it is the intention of the Parties that the foregoing respective Survival Periods and termination dates supersede any applicable statutes of limitations that would otherwise apply to such matters.
Section 7.2 Indemnification by Xxxxxx. From and after the Closing Date and subject to the provisions of this Article βVII, Aeglea shall reimburse, defend, indemnify and hold Immedica and its directors, officers, employees, Affiliates, agents, attorneys and Representatives, and each of their respective successors and permitted assigns (collectively, the βImmedica Indemnified Partiesβ) harmless from and against any and all Losses incurred, resulting or arising from or relating to:
Section 7.3 Indemnification by Immedica. From and after the Closing Date and subject to the provisions of this Article βVII, Immedica shall reimburse, defend, indemnify and hold each of Aeglea and its respective directors, officers, employees, Affiliates, agents, attorneys, Representatives, successors and permitted
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assigns (the βAeglea Indemnified Partiesβ) harmless from and against any and all Losses incurred, resulting or arising from or relating to:
Section 7.4 Indemnification Procedures.
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Section 7.5 Limitations on Indemnified Costs.
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Section 7.6 Sources of Recovery. The Milestone Set-off shall be the sole and exclusive recourse for any and all payments that may become owing to the Immedica Indemnified Parties pursuant to a claim for indemnification under this Article βVII (other than (A) pursuant to βSection 7.2(d), (B) pursuant to βSection 7.2(b) with respect to any breach of or failure to perform any covenant or obligation contained in this Agreement that by its terms contemplates performance thereof following the Closing and such breach remains uncured for a period greater than sixty (60) days after Immedica provides written notice of such breach, and (C) with respect to willful misconduct or intentional fraud (collectively, the βExcluded Indemnity Mattersβ)); provided that (i) the Immedica Indemnified Parties shall not be entitled to recover any Loss (or series of related Losses) against Aeglea or any of its Subsidiaries (other than by means of a Milestone-Setoff) with respect to an Excluded Indemnity Matter referred to in the foregoing clause (B) unless and until such Loss (or series of related Losses) equals or exceeds $100,000 and (ii) following May 22, 2026, the Immedica Indemnified Parties shall not be entitled to recover any Loss against Aeglea or any of its Subsidiaries (other than by means of a Milestone-Setoff) with respect to an Excluded Indemnity Matter referred to in the foregoing clause (A), except to the extent an Indemnification Claim in respect of such Loss was first made prior May 22, 2026 (it being understood, for the avoidance of doubt, that nothing in this proviso shall limit or otherwise affect an Immedica Indemnified Partyβs rights to recover Losses at any time with respect to an Excluded Indemnity Matter by means of a Milestone-Setoff). No claim for indemnification under this Article βVII by the Immedica Indemnified Parties shall be asserted against, and the Immedica Indemnified Parties shall not be entitled to indemnification from, Aeglea or any of its Subsidiaries for a claim for indemnification under Article βVII (other than in respect of the Excluded Indemnity Matters, but subject to the proviso in this βSection 7.6) except to the extent such recourse is limited to Milestone Set-Offs. For the avoidance of doubt, nothing in this βSection 7.6 shall limit or otherwise affect Immedicaβs right to specific performance as provided in βSection 9.3.
Section 7.7 Exclusive Remedy. Following the Closing Date, the sole and exclusive remedy of any Indemnified Parties for any Losses (including any Losses from claims for breach of contract, warranty, tortious conduct (including negligence) or otherwise and whether predicated on common Law, statute, strict liability or otherwise) that each Party may at any time suffer or incur, or become subject to, as a result of, or in connection with
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this Agreement, including any inaccuracy or breach of any representation and warranty contained in this Agreement by any Party, or any failure by any Party to perform or comply with any covenant or agreement that, by its terms, was to have been performed, or complied with, under this Agreement, shall be indemnification in accordance with this Article βVII and any Milestone Set-Off pursuant to ββSection 1.2(e), except with respect to any claim based on intentional fraud or willful misconduct or claims for specific performance pursuant to βSection 9.3, injunction or other equitable relief. For the avoidance of doubt, the limitations set forth in this Article βVII shall not apply to claims for intentional fraud or willful misconduct.
ARTICLE VIII
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TAX MATTERS
Section 8.1 Tax Matters; Cooperation. Each Party shall cooperate fully, as and to the extent reasonably requested by the other Party, in connection with the filing of Tax Returns, making of elections and any audit or other Legal Proceeding with respect to Taxes attributable to the Acquired Assets. Such cooperation shall include the retention and (upon any other Partyβs request) the provision of records and information that are reasonably relevant to any such audit or other Legal Proceeding for a period of at least six (6) years following the Closing Date. On or after the end of such period, each Party shall provide the other with at least ten (10) daysβ prior written notice before destroying any such books and records, during which period the Party receiving such notice can elect to take possession, at its own expense, of such books and records. Each Party shall make employees available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder. Each Party agrees, upon reasonable request, to use their commercially reasonable efforts to obtain any certificate or other document from any Governmental Authority or any other Person as may be necessary to mitigate, reduce or eliminate any Tax that could be imposed (including with respect to the Transaction). The Parties shall cooperate with each other in the conduct of any audit or other proceeding relating to Taxes involving the Acquired Assets.
Section 8.2 Allocation of Purchase Price; Treatment of Milestone Payments. The Initial Payment, and any Milestone Payments, for the Acquired Assets shall be allocated as determined by the mutual agreement of the Parties. The Parties shall provide such information as any of them shall reasonably request. The Parties shall (a) prepare each report relating to the federal, state and local and other tax consequences of the purchase and sale contemplated hereby in a manner consistent herewith and (b) not take any position in any tax filing, return, proceeding, audit or otherwise which is inconsistent with the position of the other parties unless permitted to do so by Law. The Parties agree and acknowledge that any Milestone Payments shall be treated for all applicable Tax purposes as additional purchase price for the Acquired Assets, except as otherwise required by applicable Law (including Section 483 of the Code)
Section 8.3 Transfer Taxes. Aeglea and Immedica shall be each responsible for 50% of any Transfer Taxes in connection with the sale and purchase of the Acquired Assets, regardless of the Person liable for such Transfer Taxes under applicable Law, and the Parties shall work together to timely file or caused to be filed all necessary documents (including all Tax Returns) with respect to such Transfer Taxes.
Section 8.4 Apportioned Obligations.
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Section 8.5 Withholding. Immedica and its Affiliates shall be entitled to deduct and withhold from any consideration payable hereunder, or other payment otherwise payable pursuant to this Agreement, the amounts required to be deducted and withheld under applicable Law. Immedica shall use commercially reasonable efforts (a) to provide prompt notice to Aeglea if Immedica determines that any payment required to be made by Immedica or any of its Affiliates is subject to any such deduction or withholding, and (b) to cooperate with Aeglea to reduce or eliminate such deduction or withholding. Any amounts so withheld shall be paid over to the appropriate Governmental Authority, and shall be treated for all purposes of this Agreement as having been paid to the applicable Person in respect to which such deduction and withholding was made.
ARTICLE IX
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MISCELLANEOUS
Section 9.1 Expenses. Except as specifically provided to the contrary in this Agreement, all costs and expenses incurred in connection with the negotiation and execution of this Agreement, and the other Instruments, and the consummation of the Transaction shall be paid by the Party incurring such costs and expenses, whether or not the Transaction is consummated.
Section 9.2 Governing Law. This Agreement and all Legal Proceedings relating to, arising out of or under or in connection with this Agreement and the Transaction, including the negotiation, execution and performance hereunder, shall be governed by, and construed in accordance with, the Laws of the State of New York, regardless of the Laws that might otherwise govern under applicable principles of choice of Law or conflicts of Law rules or provisions thereof to the extent they would result in the application of the Laws of another jurisdiction.
Section 9.3 Specific Performance. Each of Aeglea and Immedica acknowledges and agrees that any breach of this Agreement may give rise to irreparable harm for which monetary damages would not be an adequate remedy. Each Party accordingly agrees that, in addition to any other remedies available under applicable Law or this Agreement, each of Immedica and Aeglea shall be entitled to seek enforcement of the terms of this Agreement by decree of specific performance without the necessity of proving the inadequacy of monetary damages as a remedy and to obtain injunctive relief against any breach or threatened breach of this Agreement. Any Party seeking an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions of this Agreement shall not be required to provide any bond or other security in connection with such order or injunction. The rights and remedies provided for pursuant to this βSection 9.3 are cumulative to, and not exclusive of, any rights or remedies otherwise available hereunder.
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Section 9.4 Jurisdiction. The Parties agree that any Legal Proceeding seeking to enforce any provision of, or based on any matter arising out of or in connection with, this Agreement or the Transaction shall be brought exclusively in the United States District Court for the Southern District of New York or any New York State court sitting in New York City, Borough of Manhattan, so long as one of such courts shall have subject matter jurisdiction over such Legal Proceeding, and that any cause of action arising out of this Agreement shall be deemed to have arisen from a transaction of business in the State of New York, and each of the Parties hereby irrevocably consents to the jurisdiction of such courts (and of the appropriate appellate courts therefrom) in any such Legal Proceeding and irrevocably waives, to the fullest extent permitted by Law, any objection that it may now or hereafter have to the laying of the venue of any such Legal Proceeding in any such court or that any such Legal Proceeding brought in any such court has been brought in an inconvenient forum. Process in any such Legal Proceeding may be served on any Party anywhere in the world, whether within or without the jurisdiction of any such court. Without limiting the foregoing, each Party agrees that service of process on such party as provided in βSection 9.9 shall be deemed effective service of process on such party.
Section 9.5 WAIVER OF JURY TRIAL. EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.
Section 9.6 Entire Agreement. This Agreement (including all Exhibits and Schedules hereto) and other documents and instruments delivered pursuant hereto constitute the entire agreement and supersede all prior representations, agreements, understandings and undertakings, both written and oral, between the Parties, with respect to the subject matter hereof, including the License Agreement, and no Party is relying on any prior oral or written representations, agreements, understandings or undertakings with respect to the subject matter hereof and thereof.
Section 9.7 License Agreement. The Parties hereby agree that, as of Closing, (i) the License Agreement is hereby terminated in full, (ii) no rights or obligations (including any rights or obligations that purport to survive termination of the License Agreement) of either Party under the License Agreement shall survive such termination, (provided, that Immedica shall remain responsible for the payment of the invoices set forth in Schedule β9.7), and (iii) the License Agreement shall have no further force or effect. For clarity, nothing in this βSection 9.7 will be construed to limit or modify a Partyβs rights or obligations pursuant to this Agreement or any other Instrument.
(a) Aeglea, on behalf of itself, its Affiliates and its and their current and former officers, employees, stockholders, agents, representatives, attorneys, successors and assigns (collectively, the βAeglea Releasing Partiesβ), hereby irrevocably and unconditionally releases and forever discharges Immedica and its Affiliates and their current and former officers, directors, stockholders, employees, agents, representatives and attorneys (collectively, the βImmedica Releaseesβ), or any of them, from any and all Losses of any nature whatsoever, known or unknown, liquidated or unliquidated, suspected or unsuspected, fixed or contingent, in law or in equity, arising under or in connection with the License Agreement that the Aeglea Releasing Parties now have, own or hold, or at any time heretofore ever had, owned or held or could have had, owned or held against the Immedica Releasees, except for the payment of the invoices set forth in Schedule β9.7 and for any and all Losses arising from intentional fraud or willful misconduct of the Immedica Releasees.
(b) Immedica, on behalf of itself, its Affiliates and its and their current and former officers, employees, stockholders, agents, representatives, attorneys, successors and assigns (collectively, the βImmedica Releasing Partiesβ), hereby irrevocably and unconditionally releases and forever discharges Aeglea and its Affiliates and their current and former officers, directors, stockholders, employees, agents, representatives and attorneys (collectively, the βAeglea Releaseesβ), or any of them, from any and all Losses of any nature whatsoever, known or unknown, liquidated or unliquidated, suspected or unsuspected, fixed or contingent, in law or in equity,
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arising under or in connection with the License Agreement that the Immedica Releasing Parties now have, own or hold, or at any time heretofore ever had, owned or held or could have had, owned or held against the Aeglea Releasees, except for any and all Losses arising from intentional fraud or willful misconduct by the Aeglea Releasees.
Section 9.8 Amendments and Waivers. This Agreement can be amended, supplemented or changed, and any provision hereof can be waived, only by written instrument making specific reference to this Agreement signed by the Party against whom enforcement of any such amendment, supplement, modification or waiver is sought. The waiver by any Party of a breach of any provision of this Agreement shall not operate or be construed as a further or continuing waiver of such breach or as a waiver of any other or subsequent breach. No failure on the part of any Party to exercise, and no delay in exercising, any right, power or remedy hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of such right, power or remedy by such Party preclude any other or further exercise thereof or the exercise of any other right, power or remedy.
Section 9.9 Notices. All notices or other communications which are required or permitted hereunder shall be in writing and sufficient if delivered personally or sent by nationally recognized overnight courier or by registered or certified mail, postage prepaid, return receipt requested, or by email, as follows:
If to Aeglea, to:
Aeglea BioTherapeutics, Inc.
000 Xxxxxxxx Xxxxxx
Building 00, Xxxxx 000X
Waltham, MA 02453
Attn: Xxxxxxxx Xxxxxxxx
Email: [*]
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and by email to:
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Attn: General Counsel
Email: xx@xxxxxx.xxx
If to Immedica, to:
Immedica Pharma AB
Xxxxxxxxxx 0X, 000 63
Stockholm, Sweden
Attention: Chief Executive Officer; General Counsel
Email: xxxxxxxxx@xxxxxxxx.xxx; xxxxx@xxxxxxxx.xxx
With a copy (which shall not constitute notice) to:
Xxxxx Xxxx & Xxxxxxxx LLP
000 Xxxxxxxxx Xxx.
Attention: Xxxxxxx Xxxxx
Email: xxxxxxx.xxxxx@xxxxxxxxx.xxx
or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. All such notices and other communications required or permitted by this Agreement shall
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be deemed to have been duly given (a) if sent to a recipient at the proper address as determined pursuant to this βSection 9.9, by registered or certified mail, return receipt requested, five calendar days after being deposited in the United States mail, postage prepaid; (b) if sent by Express Mail, Federal Express or similar reputable overnight delivery service that maintains records of receipt for next Business Day delivery, the next Business Day after being entrusted to such service, with delivery charges prepaid or charged to the senderβs account; (c) if sent by email, on the date of transmission with electronic confirmation of transmission; and (d) if delivered by hand, on the date of delivery.
Section 9.10 Severability. If any term or other provision of this Agreement is held by a court of competent jurisdiction or other Governmental Authority to be invalid, illegal or incapable of being enforced under any applicable Law or public policy, all other terms or provisions of this Agreement shall nevertheless remain in full force and effect so long as the economic or legal substance of the Transaction is not affected in any manner materially adverse to any Party. Upon such determination that any term or other provision is invalid, illegal or incapable of being enforced, the Parties shall negotiate in good faith to modify this Agreement so as to affect the original intent of the Parties as closely as possible in an acceptable manner in order that the Transaction is consummated as originally contemplated to the greatest extent possible.
Section 9.11 No Third-Party Beneficiaries. Nothing in this Agreement shall create or be deemed to create any third-party beneficiary rights in any Person that is not a Party (or its permitted successors and assigns) except with respect to indemnification as contemplated by βSection 7.2 and βSection 7.3.
Section 9.12 Bulk Sales Laws. Immedica and Aeglea each hereby waive compliance by Aeglea with the provisions of the βbulk sales,β βbulk transferβ or similar laws of any state. Xxxxxx agrees to indemnify and hold the Immedica Indemnified Parties harmless against any and all Losses (including any Taxes) incurred or suffered by any Immedica Indemnified Party as a result of any failure to comply with any such βbulk sales,β βbulk transferβ or similar laws.
Section 9.13 Assignment. The provisions of this Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns. No Party may assign or transfer this Agreement or any rights or obligations hereunder, directly or indirectly (by operation of Law or otherwise), without the prior written approval of the other Parties and any attempted assignment without such required approval shall be null, void and of no effect; provided, that (a) Aeglea may assign its rights, interests, and obligations hereunder to an Affiliate of Aeglea or to any successor in interest (whether by merger, acquisition, asset purchase or otherwise) to all or substantially all of its business, in each case without Immedicaβs prior written approval, and (b) Immedica may assign its rights, interests, and obligations hereunder (in whole and not in part) to a wholly owned Affiliate of Immedica without Aegleaβ prior written approval; provided that any such assignment or designation pursuant to the foregoing clause β(a) or β(b) shall not relieve the assigning Party of any of its obligations hereunder or otherwise adversely affect the other Party or any of its Affiliates. Upon any permitted assignment, the references in this Agreement to a Party shall also apply to any such assignee unless the context otherwise requires.
Section 9.14 Neutral Construction. The Parties have participated jointly in the negotiation and drafting of this Agreement and, in the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as jointly drafted by the Parties and no presumption or burden of proof shall arise favoring or disfavoring any Party by virtue of the authorship of any provision of this Agreement.
Section 9.15 Counterparts; Effectiveness. This Agreement may be executed and delivered in one or more counterparts, and by the different Parties in separate counterparts, each of which when executed and delivered shall be deemed to be an original but all of which taken together shall constitute one and the same agreement, with the same effect as if the signatures thereto were upon the same instrument. Counterparts may be delivered via electronic mail (including .pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000 (e.g., xxx.xxxxxxxx.xxx)) or other transmission method and any counterpart so delivered shall be
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deemed to have been duly and validly delivered and be valid and effective as delivery of a manually executed counterpart of this Agreement. Each of the Parties represents that it has undertaken commercially reasonable steps to verify the identity of each individual person executing any such counterparts via electronic signature on behalf of such Party and has and will maintain sufficient records of the same. This Agreement shall become effective when each Party shall have received a counterpart hereof signed by all of the other Parties. Until and unless each Party has received a counterpart hereof signed by each other Party, this Agreement shall have no effect and no Party shall have any right or obligation hereunder (whether by virtue of any other oral or written agreement or other communication).
[Signature Pages Follow]
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their respective officers thereunto duly authorized, as of the date first written above.
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[Signature Page to Asset Purchase Agreement]
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Exhibit A
Definitions; Interpretations
(a) For purposes of this Agreement, the following terms shall have the meanings specified in this Exhibit A, and the terms defined in Schedule β1.2 shall have the meanings specified in such Schedule. Further, those additional capitalized terms not defined in this Exhibit A or Schedule β1.2 shall have the meaning as set forth in the Agreement.
βADA Assaysβ means the assays used in connection with the Program for anti-drug antibody testing developed pursuant to that certain Master Services Agreement by and between Aeglea and BioAgilytix Labs, LLC, dated as of October 16, 2015.
βAffiliateβ means, with respect to a Person, any other Person that controls, is controlled by, or is under common control with such Person. For purposes of this definition, βcontrolβ when used with respect to any Person means the power to direct the management and policies of such Person, directly or indirectly, whether through the ownership of voting securities, by contract or otherwise, and the terms βcontrollingβ and βcontrolledβ have correlative meanings.
βAssigned Contractsβ means the Contracts set forth on Schedule β2.1(b)(ii), including all amendments and supplements thereto and all Statements of Work and Purchase Orders thereunder.
βAssigned Intellectual Propertyβ means, any and all Intellectual Property that is owned by Aeglea or any of its Subsidiaries and used or held for use in, or otherwise related to, the conduct of the Program or any Exploitation of the Product as of the Closing, including the Intellectual Property listed on Schedule β2.1(b)(i)(A), but excluding the ADA Assays.
βAssigned Patentsβ means any and all Patents included in the Assigned Intellectual Property.
βBiological Materialsβ means any biological substances and materials, including any tissues, cells, cell lines, organisms, blood samples, genetic material, antibodies, and plasmids, in each case relating exclusively to the Product or held for exclusive use in the Program. For the sake of clarity, human tissue samples taken from a human patient in the context of a Clinical Study with respect to a Product or a Program do not relate exclusively to such Product or such Program.
βXxxx Xxxx Actβ means the Xxxx-Xxxx Act, 35 U.S.C. Β§ 200-211 together with all regulations implementing the same, including 37 CFR 401, as each may be amended from time to time.
βBLAβ means a Biologics License Application (as defined in 21 C.F.R. 600 et. seq.) filed with the FDA, and any amendments thereto.
βBusiness Dayβ means any day of the year on which national banking institutions in New York, U.S. and Stockholm, Sweden are open to the public for conducting business and are not required or authorized by applicable Law to close.
βClinical Studyβ means any investigation in human subjects intended to determine the clinical pharmacological, pharmacokinetic, and/or other pharmacodynamic effects of an investigational agent, and/or to identify any adverse reactions to an investigational agent to assess the agentβs safety and efficacy.
βCodeβ means the Internal Revenue Code of 1986, as amended.
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βContractβ means any written or oral agreement, contract, indenture, note, mortgage, loan, instrument, license, guarantee, bond, lease, commitment, understanding or undertaking.
βCPRIT Technologyβ means (i) all Patents set forth on Schedule β2.1(b)(i)(C) and (ii) any and all data generated pursuant to that certain Cancer Research Grant Contract between AERase, Inc. and Cancer Prevention and Research Institute of Texas dated as of June 1, 2014.
βDocumentsβ means all files, documents (including all documents related to past or present preclinical and clinical trials, nonclinical studies and stability studies, in each case in both raw data and processed data (i.e., JMP file) form), instruments, papers, books, reports (including clinical, preclinical and nonclinical reports, and all data sets associated with such reports), records, budgets, forecasts, ledgers, journals, supplier lists, customer data, operating data and plans (including all launch preparation documentation), technical documentation, and other similar materials, and specifically including the label components with respect to the Product, the safety database for the Product (including all source data, related correspondence with the FDA and any similar information), all information, reports, records, data or materials relating to quality assurance matters with respect to the Product, in each case whether in hard copy or electronic format; provided, that βDocumentsβ does not include Product Registrations or Permits.
βEnvironmental Lawβ means any applicable Law relating to the protection of the environment or the handling, treatment, storage, disposal or release of hazardous substances, wastes or materials.
βExpensesβ means any and all expenses, costs, claims, demands, assessments, judgments, penalties and fees (including reasonable attorneysβ and other professionalsβ fees and disbursements).
βExploitβ means to research, have researched, develop, have developed, use, have used, make, have made, sell, have sold, offer for sale, have offered for sale, commercialize, have commercialized, import, have imported, export, have exported, register, have registered, and otherwise exploit or have exploited. βExploitationβ has a correlative meaning.
βFD&C Actβ means the United States Federal Food, Drug, and Cosmetic Act, as amended, and the rules and regulations promulgated thereunder.
βFDAβ means the United States Food and Drug Administration or any successor agency thereto.
βFuji Creditβ means [*] to be paid by Aeglea to Fujifilm pursuant to the Fuji Scope of Work for services not yet rendered.
βFuji Scope of Workβ means that certain Scope of Work 7 entitled βManufacturing Pre-Production, cGMP Production, Testing and Disposition for AEB1101,β with Program Reference R2841.03, by and between Fujifilm and Aeglea dated as of November 27, 2022.
βFujifilmβ means Fujifilm Diosynth Biotechnologies U.S.A., Inc.
βGovernmental Authorityβ means any nation or government or governmental or regulatory body thereof, or political subdivision thereof, whether federal, state, local or foreign, or any agency, instrumentality or authority thereof, or any court or arbitrator (public or private) or any other entity exercising executive, judicial, legislative, regulatory or administrative functions of or pertaining to regulation or to government.
βINDβ means an Investigational New Drug Application submitted under Section 505(i) of the FD&C Act, or an analogous application or submission with any analogous agency or Regulatory Authority outside of the United States for the purposes of obtaining permission to conduct clinical trials.
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βIndebtednessβ means any amount owed by Aeglea or any of its Subsidiaries (including (i) unpaid principal, (ii) unpaid interest, (iii) premium thereon (including make-whole premiums) and (iv) prepayment penalties, breakage costs, fees, expenses or similar charges arising as a result of the discharge of such amount owed), without duplication, in respect of: (a) obligations of Aeglea or any of its Subsidiaries for borrowed money (including the current portion thereof) and related accrued interest payable in respect of such borrowed money, (b) obligations of Aeglea or any of its Subsidiaries evidenced by bonds, notes, debentures or other similar instruments (including a purchase money obligation), (c) all reimbursement obligations of Aeglea or any of its Subsidiaries relating to letters of credit, bankersβ acceptances, surety, performance bonds or other bonds or similar instruments to the extent called, drawn or otherwise due, (d) capitalized lease obligations of Aeglea or any of its Subsidiaries (including the current portion thereof) and related accrued interest payable in respect of such obligations, (e) all guarantees, including guarantees of any items set forth in clauses (a) through (d) and (f) obligations of Aeglea or any of its Subsidiaries that are secured in whole or in part by the assets of Aeglea or any of its Subsidiaries.
βIndemnification Claimβ means any claim in respect of which payment may be sought under Article βVII of this Agreement.
βIntellectual Propertyβ means any and all intellectual property rights or similar proprietary rights throughout the world, including all (i) Patents, (ii) Trademarks, (iii) copyrights and moral rights, including registrations or applications for registrations thereof and all renewals, extensions, restorations and reversions of the foregoing (βCopyrightsβ), (iv) Know-How, (v) database rights, industrial designs, industrial property rights, publicity rights and privacy rights and (vi) rights to assert, claim or sue and collect damages for the past, present or future infringement, misappropriation or other violation of any of the foregoing.
βInventoryβ means all inventory of the Product owned by Aeglea or its Subsidiaries as of the Closing Date, wherever located, including all finished goods, work in process, raw materials, cell banks, vials and other reagents, starting materials, and intermediates from the synthesis of Product.
βInventory Specificationsβ means the applicable specifications and standards set forth in the Marketing Authorization Application (EMEA/H/C/005484) submitted by Immedica to the European Medicines Agency with respect to the Product.
βIP Assignment Agreementβ means the Intellectual Property Assignment Agreement to be entered into between Aeglea (or an Affiliate thereof) and Immedica (or an Affiliate thereof) at the Closing in substantially the form attached hereto as Exhibit B.
βKnow-Howβ means any and all know-how, trade secrets, data, results, technology, business or financial information or information of any type whatsoever, in any tangible or intangible form, including practices, techniques, methods, assays, techniques, processes, protocols, inventions, discoveries, improvements, developments, specifications, formulations, formulae, algorithms, marketing reports, business plans, expertise, technology, software, test data (including pharmacological, biological, chemical, biochemical, medical, toxicological, preclinical, and clinical test data and any other research or development data), standard operating procedures, manufacturing records, stability data and other study data and procedures.
βKnowledgeβ means the actual knowledge of each of Xxxxxxxx Xxxxxxxx, Xxxxxxx Xxxxxxx and Xxx Xxxxxxxxxxx, after reasonable inquiry of each such individualβs direct reports.
βLawβ means any foreign, federal, state and local law (including common law), statute, code, ordinance, rule, regulation (including zoning and building code), permit, legislation, injunction, judgment, decree, ruling, Order or other requirement of any Governmental Authority or any securities exchange upon which a Party is listed or becomes listed.
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βLegal Proceedingβ means any judicial, administrative or arbitral actions, suits, mediations, audits, investigations, inquiries, hearings, proceedings (public or private), litigation, complaints, allegations, demands, charges, grievances, prosecutions or claims (including counterclaims).
βLiabilityβ means any debt, liability or obligation (whether direct or indirect, absolute or contingent, accrued or unaccrued, known or unknown, liquidated or unliquidated, or due or to become due) and including all costs and expenses relating thereto.
βLienβ means any lien, encumbrance, pledge, mortgage, deed of trust, security interest, charge, condition, restriction, covenant, license, purchase option, lease, sublease or other third-party right, right of first refusal, easement, right of way, servitude, transfer restriction, encroachment, reservation or title defect of any kind or nature.
βLossesβ means all damages, losses, claims, Liabilities, charges, fines, penalties, diminution in value, lost profits, judgments, amounts paid in settlement, costs and Expenses (including reasonable expenses of investigation and reasonable attorneysβ fees and expenses in connection with any Legal Proceeding, whether involving a Third-Party Claim or a claim solely between the parties hereto to enforce the provisions hereof).
βMaterial Adverse Effectβ means any fact, event, change, development, condition, circumstance or effect that, individually or in the aggregate, (A) has, or would reasonably be expected to have, a material adverse effect on the Program, the Product and the Acquired Assets taken as a whole, or (B) prevents or materially impairs or delays, would be reasonably expected to prevent or materially impair or delay, the ability of Aeglea to perform its obligations hereunder, including the consummation of the Transaction; provided that, in the case of clause (A) above, βMaterial Adverse Effectβ shall not include any such fact, event, change, development, condition, circumstance or effect to the extent it results from (i) global or national political conditions, including the outbreak or escalation of war or terrorist activities, (ii) global or national economic, monetary, or financial conditions, including changes in prevailing interest rates, credit markets, or financial market conditions in or affecting the United States, (iii) changes in applicable Law (or the interpretations thereof) or GAAP (or the interpretations of), (iv) the taking of any action specifically required to be taken by this Agreement or taken by any Party or any of its Affiliates or any of their respective Affiliates with the prior written consent or at the written request of the other Party, (v) earthquakes, hurricanes, tsunamis, typhoons, lightning, hailstorms, blizzards, tornadoes, droughts, floods, cyclones, arctic frosts, mudslides, wildfires and other natural disasters and weather conditions, (vi) impacts on relationships with suppliers, employees, labor organizations, or Governmental Authorities, in each case attributable to the execution, announcement or pendency of this Agreement or the Transaction, or (vii) changes generally in the life sciences and healthcare industries; except to the extent, in the case of clauses (i), (ii), (iii), (v) and (vii), such fact, event, change, development, condition, circumstance or effect disproportionately affects the Program, the Product or the Acquired Assets, relative to other participants in the industry or industries in which the Program operates.
βOrderβ means any order, injunction, judgment, decree, determination, ruling, writ, assessment or arbitration or other award of a Governmental Authority.
βOrdinary Course of Businessβ means, with respect to any Person or business, the ordinary course of business of such Person and its Affiliates or such business, in each case, consistent with past practices.
βPatentsβ means any and all patents (which shall include invention patents, utility models, design patents, industrial designs, and priority rights), applications for patents, invention disclosures, provisional applications, substitutions, supplementary protection certificates, reissues, reexaminations, renewals, revisions, extensions, divisionals, continuations, continuations-in-part, inventorsβ certificates, utility certificates, patents or certificates of addition, inventorsβ certificates of addition, and utility certificates of addition and other indices of invention ownership and the right to claim priority to any part of the foregoing.
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βPermitsβ means any approvals, authorizations, consents, licenses, permits or certificates (including certificates of occupancy) of a Governmental Authority.
βPermitted Liensβ means (i) Liens for Taxes, assessments or other governmental charges or levies not yet due or payable or that are being contested in good faith by appropriate Legal Proceedings and for which adequate reserves have been set aside in the relevant financial statements in accordance with generally applicable accounting principles; (ii) statutory Liens of landlords and mechanicsβ, carriersβ, warehousemenβs, workersβ, repairersβ and similar Liens imposed by applicable Law or arising or incurred in the Ordinary Course of Business with respect to amounts not yet due and payable or being contested in good faith by appropriate Legal Proceedings; (iii) Liens incurred or deposits made in the Ordinary Course of Business in connection with workersβ compensation, unemployment insurance or other types of social security; (iv) rights under the Specified Patents licensed to the U.S. Federal Government on a non-exclusive basis pursuant to the Xxxx Xxxx Act; (v) rights under the CPRIT Technology licensed to the Cancer Prevention and Research Institute of Texas on a non-exclusive basis pursuant to that certain Cancer Research Grant Contract between AERase, Inc. and Cancer Prevention and Research Institute of Texas dated as of June 1, 2014; and (vi) non-exclusive licenses that were entered into by Aeglea or any of its Subsidiaries in the Ordinary Course of Business and where the grant of rights to use any Intellectual Property is solely for any performance of services under each such agreement.
βPersonβ means any individual, corporation, limited liability company, partnership, firm, joint venture, association, joint-stock company, trust, unincorporated organization, Governmental Authority or other entity.
βProductβ means any pharmaceutical product containing, incorporating or comprising pegzilarginase (CAS Registry Number: 1659310-95-8) whether as the sole pharmaceutical ingredient, or in combination with other active pharmaceutical ingredients, in any form, formulation, mode of administration, presentation or dosage form.
βProduct Registrationsβ means (i) any approvals, clearances, registrations, licenses, listings, permits, investigational new drug exemptions, orphan drug designations, rare pediatric disease designations, clinical trial authorizations or marketing authorizations, together with any supplements or amendments thereto (collectively, βApprovalsβ), whether existing, pending or issued or in draft form, to Aeglea or an Affiliate of Aeglea by the relevant Governmental Authority prior to the Closing Date related to the research, development, manufacture, importation, distribution, marketing and/or sale of the Product, (ii) any rights that Aeglea or a Subsidiary of Aeglea has in any Approval referred to in clause (i) of this definition under any agreement pursuant to which any such Approval is held in the name of a third person, (iii) any regulatory applications, submissions, dossiers, notifications, registrations, decisions, correspondence or other filings made to or with a Regulatory Authority with respect to the Product or the Program, (iv) supporting documentation in Aegleaβs or an Affiliate of Aegleaβs files with respect to any of the foregoing clauses (i)-(iii), including annual reports and adverse event reports and (v) as applicable, complete and accurate electronic copies of all items referred to in the foregoing clauses (i)-(iv). The Product Registrations shall include INDs, Regulatory Approvals and the pricing and reimbursement approval (if applicable or available) and all national drug code numbers (if any) assigned to the Product.
βProgram Contractβ means any Contract that is primarily related to, or otherwise material to, the Product or the Program.
βRegulatory Approvalsβ means, with respect to the Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization that is required by the applicable Governmental Authority to market and sell the Product in such country or jurisdiction.
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βRegulatory Authorityβ means, with respect to a country, any national (e.g., the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other Governmental Authority involved in the granting of a Regulatory Approval or, to the extent required in such country, price approval, for biological or pharmaceutical Product in such country.
βRepresentativesβ means, with respect to any Person, such Personβs directors, officers, employees, attorneys, counsel, consultants, advisors, financing sources, accountants, auditors, authorized representatives, agents or Affiliates.
βSubsidiaryβ means, with respect to any Person, any entity of which securities or other ownership interests having ordinary voting power to elect a majority of the board of directors or other persons performing similar functions are at the time directly or indirectly owned by such first Person.
βTax Returnβ means any return (including any information return), report, statement, schedule, notice, form or other document or information filed with or submitted to, or required to be filed with or submitted to, any Taxing Authority in connection with the determination, assessment, collection or payment of any Tax or in connection with the administration, implementation or enforcement of or compliance with any Law relating to any Tax.
βTaxesβ means (I) any and all federal, state, local or foreign taxes, charges, fees, imposts, levies or other assessments, including all net income, gross receipts, capital, sales, use, ad valorem, value added, transfer, franchise, profits, inventory, capital stock, license, withholding, payroll, employment, social security, unemployment, excise, severance, stamp, occupation, property and estimated taxes, customs duties, fees, assessments and charges of any kind whatsoever, together with any such Liabilities for any other Person, whether arising by reason of consolidated, combined, or similar Tax Returns, as a transferee, by contract, by operation of Law, or otherwise; and (ii) all interest, penalties, fines, additions to tax or additional amounts imposed by any Taxing Authority in connection with any item described in clause (i) above.
βTaxing Authorityβ means any Governmental Authority responsible for the administration of any Tax.
βThird Partyβ means any Person other than the Parties or any of their respective Affiliates.
βTrademarksβ means any and all trademarks, service marks, logos, slogans, trade names, trade dress, internet domain names, social media handles, and any other indicator of the source of origin of goods or services, including all applications and registrations of, and all goodwill associated with, the foregoing.
βTransactionβ means the purchase and sale of the Acquired Assets and the assumption of the Assumed Liabilities as contemplated by this Agreement.
βTransfer Taxesβ means any and all sale, use, stamp, documentary, filing, recording, transfer, gross receipts, registration, duty or similar fees or Taxes or governmental charges (together with any interest or penalty, addition to tax or additional amount imposed) as levied by any Taxing Authority on the purchase and sale of the Acquired Assets.
βUnited Statesβ or βU.S.β means the United States of America and its territories, possessions and commonwealths.
(b) Other Definitional and Interpretive Matters. Unless otherwise expressly provided, for purposes of this Agreement, the following rules of interpretation shall apply:
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(i) Calculation of Time Periods. When calculating the period of time before which, within which or following which any act is to be done or step taken pursuant to this Agreement, the date that is the reference date in calculating such period shall be excluded. If the last day of such period is a non-Business Day, the period in question shall end on the next succeeding Business Day.
(ii) Currency. Unless otherwise specified in this Agreement, all references to β$β and dollars set forth herein shall mean United States (U.S.) dollars.
(iii) Exhibits/Schedules. The Exhibits and Schedules to this Agreement are an integral part of this Agreement and are hereby incorporated herein and made a part hereof as if set forth herein. Any capitalized terms used in any Exhibit or Schedule but not otherwise defined therein shall be defined as set forth in this Agreement. The representations and warranties contained in Article βIV are qualified by reference to the Schedules attached hereto and referred to in Article βIV (collectively, the βDisclosure Scheduleβ). The Parties acknowledge and agree that (i) the Disclosure Schedule may include items or information that Aeglea is not required to disclose under this Agreement, (ii) disclosure of such items or information shall not be deemed to expand the scope of the representations and warranties of Aeglea under this Agreement, (iii) inclusion of information in the Disclosure Schedule shall not be construed as an admission that such information is necessarily material in any respect and (iv) reference in a particular Section of the Disclosure Schedule shall only be deemed to be an exception to (or, as applicable, a disclosure for purposes of) (A) the representations and warranties (or covenants and agreements, as applicable) of Aeglea that are contained in the corresponding Section of this Agreement and (B) any other representation and warranty (or covenant and agreement, as applicable) of Aeglea that is contained in this Agreement, but only if the relevance of that reference as an exception to (or a disclosure for purposes of) such representation and warranty (or covenant and agreement, as applicable) would be reasonably apparent to a reasonable person without any independent knowledge regarding the matter(s) so disclosed.
(iv) Gender and Number. Any reference in this Agreement to gender shall include all genders, and words imparting the singular number only shall include the plural and vice versa.
(v) Headings. The provision of the Table of Contents, the division of this Agreement into Articles, Sections and other subdivisions and the insertion of headings are for convenience of reference only and shall not affect or be utilized in construing or interpreting this Agreement. All references in this Agreement to any βArticle,β βSectionβ or other subdivision are to the corresponding Article, Section or other subdivision of this Agreement unless otherwise specified.
(vi) Herein. Words such as βherein,β βhereinafter,β βhereof,β βhereunderβ and βheretoβ refer to this Agreement as a whole and not merely to a subdivision in which such words appear unless the context otherwise requires.
(vii) Including. The word βincludingβ or any variation thereof means βincluding without limitation,β unless otherwise specified and shall not be construed to limit any general statement that it follows to the specific or similar items or matters immediately following it.
(viii) Other. The word βorβ shall be exclusive; references to βwrittenβ or βin writingβ include in electronic form (including email); any reference to βdaysβ means calendar days unless Business Days are expressly specified; and references to any statute, rule, regulation, law or applicable Law shall be deemed to refer to all applicable Laws as amended or supplemented from time to time and to any rules, regulations and interpretations promulgated thereunder.
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Exhibit B
IP Assignment Agreement
B-1
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Exhibit C
Specified Patent Assignment Agreement
C-1
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Exhibit D
Specified Patent License Agreement
D-1