EX-10.3 3 a14-9752_1ex10d3.htm EX-10.3 [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions....
Exhibit 10.3
[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
ASSIGNMENT AND NOVATION AGREEMENT
BETWEEN
BAYER CONSUMER CARE AG
AND
KYTHERA HOLDINGS LTD.
ASSIGNMENT AND NOVATION AGREEMENT
THIS ASSIGNMENT AND NOVATION AGREEMENT (this “Agreement”), is entered into as of March 7, 2014 (the “Effective Date”), by and among Bayer Consumer Care AG, a company organized under the laws of Switzerland (“Bayer”) and KYTHERA Holdings Ltd., a company incorporated under the laws of Bermuda (“KHL”) (each, a “Party” and together, the “Parties”) and, with respect to Article 2 and Sections 5.3 and 8.4 hereof only, KYTHERA Biopharmaceuticals Inc., a Delaware corporation (“Parent”).
Agreement”), the issuance of a note from Parent to KHL dated as of the Effective Date, and assigned from KHL to Bayer as of the Effective Date, a form of which is attached as Exhibit B hereto (“Note”), and the payment of certain milestone payments and other consideration, as provided herein; and
NOW THEREFORE, the Parties agree as follows:
Except as otherwise set forth below, all capitalized and undefined terms in this Agreement shall have the meanings set forth in the Amended License Agreement or the Collaboration Agreement, as applicable:
1.1 “Amended License Agreement” has the meaning set forth in the WHEREAS clauses.
1.2 “Annual Ex-Manufacturer Sales” means the total amounts invoiced by KHL, its Affiliates and their respective Sublicensees for sales of all Products (combined as if they were one Product for this purpose) to Third Parties (including Distributors) in a calendar year, less the following deductions to the extent estimated as percentages below or included and itemized in the applicable invoice:
(a) normal and customary trade, cash and quantity allowances or discounts granted and taken directly with respect to sales of such Products;
(b) amounts actually repaid or credited by reason of defects, rejections, recalls, returns, rebates and allowances;
(c) charge-backs and other amounts paid on sale or dispensing of Products;
(d) Third Party cash rebates related to sales of Products, to the extent allowed;
(e) retroactive price reductions that are actually allowed or granted;
(f) [*] of the total gross invoice amount for any amounts which are not collected by KHL or its Affiliates or their respective Sublicensees, including bad debts;
(g) compulsory refunds, credits and rebates related to the sale of Products, accrued, paid or deducted pursuant to agreements (including without limitation managed care agreements) or applicable Law;
(h) [*] of the total gross invoice amount for transportation, freight insurance, distribution, packaging and handling costs;
[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(i) sales taxes, value added taxes, excise taxes and customs duties, or other consumption taxes and compulsory payments to Governmental Authorities or other governmental charges imposed on the sale of Products; and
(j) as agreed by the Parties, any other specifically identifiable costs or charges included in the gross invoiced sales price of such Products falling within categories substantially equivalent to those listed above, and ultimately credited to customers or a Governmental Authority or agency thereof.
Notwithstanding the foregoing, amounts billed by KHL, its Affiliates, or their respective Sublicensees for the sale of Products among KHL, its Affiliates or their respective Sublicensees for resale shall not be included in the computation of Annual Ex-Manufacturer Sales hereunder. For purposes of determining Annual Ex-Manufacturer Sales, the Products shall be deemed to be sold when invoiced and a “sale” shall not include reasonable transfers or dispositions, at no cost, as samples or for charitable purposes, or transfers or dispositions at no cost for preclinical, clinical or regulatory purposes. Each of the deductions set forth above shall be reasonable and customary, and in accordance with KHL’s financial systems and with U.S. Generally Accepted Accounting Principles, consistently applied.
For Combination Products, the Annual Ex-Manufacturer Sales used for the calculation of milestones under Section 5.3 shall be determined by multiplying the Annual Ex-Manufacturer Sales of such Combination Product by the fraction A/(A+B), where A equals the standard sales price of the Product containing the same amount of the Compound as the sole active ingredient contained in such Combination Product, and B equals the standard sales price of the ready-for-sale form of a product containing the same amount of the other therapeutically active ingredient(s) contained in the Combination Product. In the event that no separate sales are made of either the Product or the other product(s) contained in such Combination Product, the reasonably estimated commercial value thereof, as determined by mutual agreement of the Parties, will be used instead of the standard sales price.
For Bundled Products, the Annual Ex-Manufacturer Sales used for the calculation of milestones under Section 5.3 shall be determined by multiplying the Annual Ex-Manufacturer Sales of such Bundled Product by the fraction X/(X+Y), where X equals the standard sales price of the Product included in the Bundled Product, and Y equals the standard sales price of the other product(s) included in such Bundled Product. In the event that no separate sales are made of either the Product or the other product(s) contained in such Bundled Product, then the standard sales price of such Product or other product(s) when last on the market in such country shall be used. In the event that such Product or other product(s) have never been on the market, the reasonably estimated commercial value thereof, as determined by mutual agreement of the Parties, will be used instead of the standard sales price.
1.3 “Assigned IP” has the meaning set forth in Section 4.1.
1.4 “Bayer Indemnitees” has the meaning set forth in Section 8.1.
1.5 “Bayer Retained IP” has the meaning set forth in Section 4.2.
1.6 “Collaboration Agreement” has the meaning set forth in the WHEREAS clauses.
1.7 “Indemnified Party” has the meaning set forth in Section 8.3.
1.8 “Indemnifying Party” has the meaning set forth in Section 8.3.
1.9 “Intendis” has the meaning set forth in the WHEREAS clauses.
1.10 “KHL Indemnitees” has the meaning set forth in Section 8.2.
1.11 “Losses” means, with respect to a Party, any and all liabilities, expenses and/or losses, including without limitation (i) reasonable legal expenses and attorneys’ fees for external counsel that are incurred by or on behalf of such Party, and (ii) documented internal costs (including general and administrative expenses) incurred by or on behalf of such Party to the extent that such costs are charged on a basis consistent with such Party’s ordinary business practices consistently applied, and consistent with industry standards.
1.12 “Note” has the meaning set forth in the WHEREAS clauses.
1.13 “Original License Agreement” has the meaning set forth in the WHEREAS clauses.
1.14 “Parent Common Stock” has the meaning set forth in the WHEREAS clauses.
1.15 “Registration Rights Agreement” means that certain Registration Rights Agreement, dated as of the Effective Date, among Bayer, Parent and KHL that provides for, among other things, the registration of the Parent Common Stock for sale by Bayer under the Securities Act of 1933, as amended.
1.16 “Restructuring Agreement” has the meaning set forth in the WHEREAS clauses.
1.17 “Securities Purchase Agreement” has the meaning set forth in the WHEREAS clauses.
1.18 “Third Party” means any person other than the Parties and their respective Affiliates.
1.19 “TSA” has the meaning set forth in Section 3.1.
ARTICLE 2 AMENDED LICENSE AGREEMENT
2.1 Amendment. Except as otherwise expressly provided in the Assignment and Novation Agreement, KHL acknowledges that Bayer and Parent have entered into the Amended License Agreement to remove Bayer’s obligations to Develop, manufacture, or Commercialize the Compound and Products, and that accordingly, upon and after the Effective Date, Bayer shall have no obligations with respect to the Development, manufacture or Commercialization of the Compound and Products, nor shall it have any obligation, express or implied, to use Commercially Reasonable Efforts, or any other level of efforts, in connection with such activities except for those expressly provided in the Amended License Agreement.
2.2.1 Bayer hereby transfers, by novation, as of the Effective Date, all of its right, title, and interest in and to the Amended License Agreement, and assigns all of its rights and delegates all of its obligations, liabilities and duties thereunder, to KHL. KHL hereby expressly assumes all rights and obligations, liabilities and duties of Bayer upon and after the Effective Date under the Amended License Agreement, in every way as if KHL were, and had originally been, a party to the Amended License Agreement in place of Bayer, except as expressly provided in Sections 2.3.2 and 2.4.
2.2.2 Parent, KHL and Bayer each consent to the transfer by novation set forth in Section 2.2.1 and agrees that Bayer’s rights and obligations, liabilities and duties under the Amended License Agreement are hereby novated and assigned and delegated, as applicable, to KHL as of the Effective Date. KHL hereafter shall have all rights and obligations, liabilities and duties of Bayer under the Amended License Agreement upon and after the Effective Date except as expressly provided in Sections 2.3.2 and 2.4.
2.2.3 Parent hereby consents to the assignment and novation by Bayer set forth in Section 2.2.1 and confirms that such assignment and novation shall, except as otherwise expressly provided in Sections 2.3.2 and 2.4, fully relieve Bayer of all of its rights and extinguish all of its obligations, liabilities and duties to Parent under the Amended License Agreement. Parent hereby accepts the obligations of KHL under the Amended License Agreement in place of the obligations of Bayer, upon and after the Effective Date. Bayer shall be removed as a party thereto upon and after the Effective Date without any action on the part of either party to the Amended License Agreement.
2.3 Releases.
2.3.1 Bayer and its Affiliates, on the one hand, and Parent, KHL, and their Affiliates, on the other hand, hereby release and forever discharge, except as otherwise expressly provided in Sections 2.3.2 and 2.4, each other, and their respective partners, members, shareholders, subsidiaries, officers, directors, agents, servants, employees, assigns, successors, affiliates and attorneys, from any and all claims, demands, causes of action, suits, debts, dues, duties, sums of money, accounts, covenants, contracts, agreements, promises, damages, judgments, liabilities and obligations, both contingent and fixed, known and unknown, of every kind and nature whatsoever in law or equity, or otherwise, under local, state or federal law, which they ever had or ever will have in the future relating in any way to, or arising in connection with, the Original License Agreement, the Amended License Agreement, and the assignment and novation thereof set forth in Section 2.1.
2.3.2 The relief, extinguishment, release and discharge provided for in Section 2.3.1 shall not apply to (a) any indemnification obligations contained in the Original License Agreement or Amended License Agreement that are applicable to acts or omissions of Parent or Bayer occurring prior to the Effective Date, (b) those rights and obligations under the Amended License Agreement that survive as set forth in Section 2.4, or (c) all rights and obligations, and any claims of the Parties and their Affiliates for acts or omissions occurring after the Effective
Date under this Agreement, the Restructuring Agreement, the Note, the Securities Purchase Agreement, the Registration Rights Agreement, or the TSA.
2.4 Survival of Obligations Under the Amended License Agreement. Notwithstanding anything in this ARTICLE 2 to the contrary, Parent and Bayer acknowledge and agree that the foregoing assignment and novation does not relieve Parent or Bayer of their rights and obligations to each other under the following provisions of the Amended License Agreement solely to the extent such sections pertain to activities conducted by and obligations applicable to Parent and/or Bayer prior the Effective Date: Sections 3.2 (provided that Bayer shall not have the right to review Parent’s records), 4.8 (for the period set forth therein), 4.9, 8.1, 8.2, 8.4, 8.5, 8.6, 8.8, 8.9, 11.4, 11.5, 11.6(a) (solely with regard to any rights and obligations that continue to apply to Parent and/or Bayer with respect to activities conducted and obligations applicable prior to the Effective Date as provided in this Section 2.4), 11.9-11.13 and Articles 1, 7 and 10. Accordingly, the foregoing provisions shall survive as obligations of Parent and Bayer after the assignment effected in this Agreement becomes effective.
ARTICLE 3 TRANSITION ACTIVITIES
(a) Bayer, Intendis and their Affiliates shall make available certain staff members for an agreed-upon amount of time during the transition period to answer any reasonable questions KHL may have regarding any Information or Technology transferred to KHL, as specified in the TSA. Thereafter, KHL may propose from time to time that Bayer, Intendis and their Affiliates support KHL, including with respect to such Information and Technology, by providing staff members and performing additional activities, on terms to be specified by the Parties in the TSA.
(b) Bayer, Intendis and their Affiliates shall continue, during the period specified in the TSA, to perform certain ongoing activities related to the Compound and the Product, as further set forth in the TSA.
(c) From and after the Effective Date, Bayer, Intendis and their Affiliates shall not file any new clinical trial applications or commence, in any way, any new clinical trials for Compound or Product. Bayer, Intendis and their Affiliates shall conduct no other development, marketing, or commercialization activities with respect to Compound or Product, except to the extent expressly specified in the TSA.
(a) Bayer, Intendis and their Affiliates, as applicable, shall, consistent with the transition plan contemplated by the TSA, and subject to the conditions in the TSA, terminate, in whole or in relevant part, Third Party Agreements identified in the TSA;
(b) Bayer, Intendis and their Affiliates shall not enter into any new agreements with Third Parties that relate to the Development or Commercialization of Products under the Amended License Agreement, or any other activities under the Amended License Agreement; and
(c) Any new agreements that are entered into by KHL with Third Parties that relate to the Development or Commercialization of Products in the BCC Territory under the Amended License Agreement during the first three (3) years after the Effective Date shall contain an acknowledgment by each such Third Party to the effect that Bayer is not a party
to such agreement and that Bayer is no longer involved in the development, manufacture or commercialization of the Compound and/or the Product in the BCC Territory.
3.2 Activities Prior to the Execution of the TSA.
3.2.1 KHL shall provide written notice to Bayer prior to engaging in consultations with Regulatory Authorities prior to the execution of the TSA.
3.2.2 Each Party shall designate a transition manager to coordinate the regulatory and development activities prior to the execution of the TSA. The two (2) transition managers are authorized to make interim decisions to transition to KHL the rights and responsibilities described in this ARTICLE 3 prior to the execution of the TSA upon their mutual agreement, to minimize or avoid any delays or interruptions in the development and manufacture of the Products from the Effective Date until the execution of the TSA.
3.2.3 KHL shall compensate Bayer and its Affiliates for any transition services provided by Bayer and its Affiliates in accordance with Section 3.2.2 prior to the execution of the TSA within thirty (30) days after the execution of the TSA at the rate and on the terms set forth in the TSA.
ARTICLE 4 INTELLECTUAL PROPERTY
of Developing, making, using, selling, offering to sell, importing, exporting, or otherwise Commercializing and obtaining Regulatory Approval of the Compound and Products.
4.3 Potential Patentable Inventions. Notwithstanding the provisions of 4.2:
4.3.1 Notification to KHL. Within thirty (30) days of the Effective Date, Bayer shall notify KHL if it believes any of the Bayer Retained IP could potentially constitute a patentable invention but which is, as of the Effective Date, not the subject of a filed or pending Patent (such Bayer Retained IP, a “Potential Patentable Invention”), and shall provide to KHL a brief written description of such Potential Patentable Invention. All such disclosures to KHL shall constitute the Confidential Information of Bayer.
4.3.2 Bayer Retained Patents. For [*] following the Effective Date (the “Election Period”), Bayer and its Affiliates shall have the sole right to seek Patent protection for each Potential Patentable Invention. During the Election Period, KHL shall not, and shall cause its Affiliates not to, seek Patent protection with respect to such Potential Patentable Invention. Bayer and its Affiliates (i) shall retain all of their right, title and interest, including all intellectual property rights, in and to any Potential Patentable Invention which, in whole or in part, is disclosed or claimed in an application for Patent filed prior to the expiration of the Election Period (whether or not a Patent ultimately issues), and (ii) hereby grant to KHL and its Affiliates an exclusive, royalty-free, perpetual, irrevocable, sublicenseable license under their right, title and interest, including all intellectual property rights, in and to all such Potential Patentable Inventions, solely for the purpose of Developing, making, using, selling, offering to sell, importing, exporting, or otherwise Commercializing and obtaining Regulatory Approval of the Compound and Products.
4.3.3 KHL Assumed Patents. If Bayer does not file an application for a Patent with respect to any Potential Patentable Invention prior to the expiration of the Election Period, KHL may seek Patent protection with respect to such Potential Patentable Invention. Bayer shall also, after the expiration of the Election Period, continue to have the right to seek Patent protection with respect to such Potential Patentable Invention. If KHL desires to seek such Patent protection for such Potential Patentable Invention after the Election Period, provided that Bayer has not already done so, KHL shall notify Bayer of the same, and Bayer and its Affiliates shall and hereby do assign to KHL, effective as of the date of such notice, all of their right, title and interest, including all intellectual property rights, in and to such Potential Patentable Invention (an “Assumed Patentable Invention”). KHL shall and hereby does grant to Bayer and its Affiliates, effective as of the date of such notice, an exclusive, royalty-free, perpetual, irrevocable, sublicenseable license under its right, title and interest, including all intellectual property rights, in and to all Assumed Patentable Inventions, solely for the purpose of Developing, making, using, selling, offering to sell, importing, exporting, or otherwise Commercializing and obtaining Regulatory Approval of compounds and products other than the Compound and Products. If Bayer desires to seek such Patent protection for such Potential Patentable Invention after the Election Period, provided that KHL has not already done so, Bayer shall notify KHL of the same, and Bayer shall and hereby does grant to KHL and its Affiliates, effective as of the date of such notice, an exclusive, royalty-free, perpetual, irrevocable, sublicenseable license under its right, title and interest, including all intellectual property rights, in and to such Potential Patentable Invention, solely for the purpose of Developing, making,
[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
using, selling, offering to sell, importing, exporting, or otherwise Commercializing and obtaining Regulatory Approval of the Compound and Products.
4.4 License To Bayer Under Assigned IP. KHL hereby grants to Bayer and its Affiliates a non-exclusive, royalty-free, sublicenseable license under the Assigned IP, and a sublicense under the Licensed Intellectual Property, solely to the extent necessary to perform Bayer’s obligations under ARTICLE 3 and the TSA.
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As an inducement for Bayer’s agreement to execute this Agreement, Parent hereby guarantees the payment obligations pursuant to this ARTICLE 5 such that if KHL fails to make any payment pursuant to this Section 5.3 when due and in the manner required by ARTICLE 5, then within thirty (30) days after the date that Bayer has provided written notice to Parent of such failure, if KHL has not made such payment prior to the expiration of such time period or otherwise resolved such failure to the satisfaction of Bayer, Parent shall assume all such payment obligations, and thereafter Parent shall have a direct obligation to Bayer equal to that of KHL.
[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Bayer hereunder, shall be calculated in U.S. Dollars. Amounts in a currency other than U.S. Dollars shall be converted into U.S. Dollars at the respective average annual exchange rate for the respective calendar year. The average annual exchange rate shall be determined as the arithmetic average of the daily (other than a Saturday, Sunday or public holiday as defined by the European Central Bank) reference rates within the respective calendar year of that currency versus the Dollar as determined and published by the European Central Bank on its website (xxxx://xxx.xxx.xxx/xxxxx/xxxxxxxx/xxxxxxxxx/xxxx/xxxxx.xx.xxxx) or, as the case may be, any successor page.
[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
of payment, provided that Bayer shall use commercially reasonable efforts to deliver any necessary forms and certificates complying with applicable law, duly executed, to reduce or eliminate any applicable withholding tax, and (ii) exclusive of value added tax (“VAT”). VAT applies additionally as legally owed, payable after receipt of a proper invoice, which meets all legal requirements according to the applicable VAT-law.
(a) If KHL is required by law (including any change in law or any request, rule, guideline or directive (whether or not having the force of law) after the date hereof) to make any deduction or withholding on account of any tax from any sum paid or payable by it to Bayer hereunder and under any other agreement or document between KHL and Bayer: (A) KHL shall notify Bayer of any such requirement or any change in any such requirement as soon as KHL becomes aware of it; (B) KHL shall pay any such tax before the date on which penalties attach thereto, such payment to be made (if the liability to pay is imposed on KHL) for its own account or (if that liability is imposed on Bayer) on behalf of and in the name of Bayer; (C) the sum payable by KHL in respect of which the relevant deduction, withholding or payment is required shall be increased to the extent necessary to ensure that, after the making of that deduction, withholding or payment, Bayer receives on the due date a net sum equal to what it would have received had no such deduction, withholding or payment been required or made; and (D) within thirty (30) days after paying any sum from which it is required by law to make any deduction or withholding, and within thirty (30) days after the due date of payment of any tax which it is required by clause (B) above to pay, KHL shall deliver to Bayer evidence satisfactory to the other affected parties of such deduction, withholding or payment and of the remittance thereof to the relevant taxing or other authority. Notwithstanding the foregoing or anything herein to the contrary, if any additional amount required to be paid to Bayer under this clause 5.8.2(a) above shall increase solely as a result of any assignment of this Agreement (or portion thereof) by Bayer to any other entity, KHL shall not be responsible for such increased amounts but shall only be responsible for the amount payable pursuant to this clause 5.8.2(a) immediately prior to the effectiveness of such assignment.
(b) If KHL is required to pay any additional amount to Bayer pursuant to clause 5.8.2(a) above, then Bayer shall use reasonable efforts to assign its rights and obligations hereunder to another of its offices, branches or affiliates, if, in the reasonable judgment of Bayer, such assignment (A) would eliminate or reduce materially amounts payable pursuant hereunder, (B) would not subject Bayer to any unreimbursed cost or expense, (C) would not require Bayer to take any action inconsistent with its internal policies or legal or regulatory restrictions, and (D) would not otherwise be disadvantageous to Bayer. KHL shall pay all reasonable costs and expenses incurred by Bayer in connection with any such assignment. A certificate setting forth such costs and expenses submitted by Bayer to KHL shall be conclusive absent manifest error.
ARTICLE 6 REPRESENTATIONS AND COVENANTS
6.1 Mutual Representations. Each Party represents as follows as of the Effective Date:
6.1.1 It is a corporation, company, or other entity duly organized or incorporated, validly existing and in good standing under the laws of its jurisdiction as set forth on the first page of this Agreement, is qualified to do business and is in good standing as a foreign corporation or other entity in each jurisdiction in which the performance of its obligations hereunder requires such qualification, and has all requisite power and authority, corporate or otherwise, to conduct its business as now being conducted and to execute, deliver and perform this Agreement.
6.1.2 The execution, delivery and performance by it of this Agreement have been duly authorized by all necessary corporate action, and do not and will not:
(a) require any consent or approval of its stockholders or any government authority, except the approvals of the applicable Regulatory Authorities for the transfer of the MAA Approvals; or
(b) violate any provision of any law, rule, regulation, order, writ, judgment, injunction, decree, determination or award presently in effect having applicability to it or any provision of its charter documents.
6.1.3 This Agreement is legal, valid and binding and any obligations under this Agreement are enforceable in accordance with their respective terms and conditions.
6.1.4 It is not under any obligation to any person, or entity, contractual or otherwise, that is materially conflicting or materially inconsistent in any respect with the terms of this Agreement or that would materially impede the diligent and complete fulfillment of its obligations.
6.2 Bayer Representation. Bayer represents as follows as of the Effective Date:
6.2.1 It has disclosed all inventions and intellectual property rights Controlled by Bayer and its Affiliates that are necessary for or actually used in, as of the Effective Date, the Developing, making, using, selling, offering to sell, importing, exporting, or otherwise Commercializing and obtaining Regulatory Approval of the Compound and Product in the form and for use with the delivery technology described in pending Regulatory Filings.
6.2.2 Neither Bayer nor its Affiliates have assigned, transferred, conveyed, licensed or otherwise granted to any Third Party any right, title, or interest in or to the Assigned IP, and neither Bayer nor its Affiliates are aware of any Third Party having any interest therein, including without limitation any liens or encumbrances with respect thereto.
ARTICLE 7 CONFIDENTIALITY AND DISCLOSURE
(a) was already known to the receiving Party or its Affiliates, other than under an obligation of confidentiality, at the time of disclosure by the other Party;
(b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party or its Affiliates;
(c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party or its Affiliates in breach of this Agreement;
(d) is subsequently disclosed to the receiving Party or its Affiliates by a Third Party who has a legal right to make such disclosure; or
(e) is subsequently independently discovered or developed by the receiving Party or its Affiliates without the aid, application, or use of the disclosing Party’s Confidential Information, as evidenced by a contemporaneous writing.
(a) such disclosure is reasonably necessary for the prosecuting or defending litigation as contemplated by this Agreement;
(b) such disclosure is reasonably necessary: (i) to such Party’s directors, attorneys, independent accountants, financial advisors or other service providers for the sole purpose of enabling such parties to provide advice to the receiving Party, provided that in each such case on the condition that such parties are bound by confidentiality and non-use obligations; or (ii) to actual or potential investors and/or acquirers, or merger partners solely for the purpose of evaluating an actual or potential investment or acquisition; provided that in each such case on the condition that such actual or potential investors and/or acquirers are bound by confidentiality and non-use obligations no less stringent than those contained in this Agreement;
(c) such disclosure is required by judicial or administrative process or rules of a securities exchange, provided that in such event such Party shall promptly inform the other Party as to such required disclosure and provide the other Party an opportunity to challenge or limit the disclosure obligations. Confidential Information that is disclosed by judicial or administrative process or rules of a securities exchange shall remain otherwise subject to the confidentiality and non-use obligations of this ARTICLE 7, and the Party disclosing Confidential Information pursuant to this Section 7.3(c) shall take all steps reasonably necessary, including seeking of confidential treatment or a protective order to ensure the continued confidential treatment of such Confidential Information; or
(d) in the case of KHL or its Affiliates, such disclosure is reasonably necessary to its subcontractors, licensees or other collaborators or partners (including potential and future collaborators and partners) for the purpose of the Development, conduct of Regulatory Activities with respect to, manufacture and/or Commercialization of the Products, on the condition that such subcontractors, licensees or other collaborators or partners are bound by confidentiality and non-use obligations at least as stringent as those contained in this Agreement.
Agreement, and the business rationale for the Agreement, which may be released to Third Parties.
8.1.1 any material breach of a representation, warranty or covenant made by Parent or KHL in this Agreement, the Note, the Securities Purchase Agreement, the Registration Rights Agreement, or the TSA;
8.1.2 any negligent act or omission or willful misconduct of any of the KHL Indemnitees in connection with this Agreement, the Note, the Securities Purchase Agreement, the Registration Rights Agreement, or the TSA; or
8.1.3 any activity performed directly in connection with the Development, manufacture, or Commercialization of the Compound or the Product by or on behalf of Parent or KHL, or their Affiliates, licensees, subcontractors or distributors (other than Bayer and its Affiliates, subcontractors or distributors) prior to or after the Effective Date, including without limitation personal injury or death, or any damage to any property, caused by a defect in any Compound or finished Product manufactured by or on behalf of Parent or KHL, or their Affiliates, licensees, subcontractors or distributors (other than Bayer and its Affiliates, subcontractors or distributors) prior to or after the Effective Date.
8.2.1 any material breach of a representation, warranty or covenant made by Bayer in this Agreement, the Note, the Securities Purchase Agreement, the Registration Rights Agreement, or the TSA; or
8.2.2 any negligent act or omission or willful misconduct of any of the Bayer Indemnitees in connection with this Agreement, the Note, the Securities Purchase Agreement, the Registration Rights Agreement, or the TSA.
“Indemnifying Party”) in writing of any Third Party Claim which the Indemnified Party has determined has given or could give rise to a right of indemnification under this Agreement. Failure to promptly notify the Indemnifying Party of any such claim shall not relieve the Indemnifying Party of any such duty to so indemnify except to the extent that the Indemnifying Party can demonstrate actual loss and prejudice as a result of such failure. The Indemnifying Party shall have the obligation to control the defense of the Indemnified Party against any such Third Party Claim, utilizing counsel chosen in the Indemnifying Party’s sole discretion; provided, however, that the Indemnified Party may participate in any such defense, at its own expense, by separate counsel of its choice; provided further, that any such participation shall not limit the Indemnifying Party’s right to control such defense. Notwithstanding the foregoing, the Indemnifying Party shall obtain the prior written approval of the Indemnified Party, not to be unreasonably withheld or delayed, before (i) admitting any liability or fault of the Indemnified Party, (ii) ceasing to defend against any Third Party Claim or (iii) entering into any settlement, adjustment or compromise of such Third Party Claim involving injunctive or similar equitable relief being asserted against any Indemnified Party or any of its Affiliates. The Indemnified Party shall cooperate with the Indemnifying Party in the provision of any such defense by providing to the Indemnifying Party all such information, assistance and authority as may reasonably be requested by the Indemnifying Party.
the other Party within forty-five (45) days after the period for resolution by the Chief Executives has expired.
9.3.1 Any arbitration under this Section 9.3 shall be conducted with the applicable ICC Rules as such Rules may be amended from time to time. In such arbitration the governing law to be applied is as described in Section 11.11. The International Bar Association Rules on the Taking of Evidence in International Commercial Arbitration shall govern the taking of evidence in any such proceeding, it being the intent of the Parties to enable a reasonable amount of discovery in any such proceeding.
9.3.2 The arbitration shall be conducted by a panel of three (3) arbitrators. Within ten (10) days after receipt of an arbitration notice from a Party, each Party shall select one (1) arbitrator with relevant industry experience and the International Court of Arbitration of the ICC (the “Court”) shall select a third arbitrator in accordance with the Rules. In the event that only one of the Parties selects an arbitrator, then the Court shall select an arbitrator in accordance with the Rules for such Party, and a third arbitrator in accordance with the Rules. Each and every arbitrator of the arbitration panel conducting the arbitration must and shall agree to render an opinion within twenty (20) days (or sixty (60) days if a Party requests a written opinion of the findings of fact and conclusion of law pursuant to Section 9.3.5 below) after the final hearing before the panel.
9.3.3 The place of arbitration shall be London, England, and the language used in any such proceeding (and for all testimony, evidence and written documentation) shall be English.
9.3.4 The Parties acknowledge that they desire for any arbitration to be conducted in an efficient, speedy and economical manner. The Parties shall use good faith efforts to complete arbitration under this Section 9.3 within one hundred eighty (180) days following the initiation of such arbitration. In order to effectuate this desire, the arbitral panel shall establish procedures reasonably directed to facilitating such goals and completing such arbitration within such one hundred eighty (180) day period.
9.3.5 The decision or award of the arbitral panel shall be final and binding and incontestable and may be used as a basis for judgment thereon in any jurisdiction. To the full extent permissible under Laws, the Parties hereby expressly agree to waive the right to appeal from the decision of the arbitrator(s), there shall be no appeal to any court or other authority (government or private) from the decision of the arbitrator(s), and the Parties shall not dispute nor question the validity of such decision or award before any regulatory or other authority in any jurisdiction where enforcement action is taken by the Party in whose favor the decision or award is rendered, except in the case of fraud or on the grounds established under Article V of the Convention on the Recognition and Enforcement of Foreign Arbitral Awards. The arbitrator(s) shall, upon the request of either Party, issue a written opinion of the findings of fact and conclusions of law and shall deliver a copy to each of the Parties. Without limiting any other remedies that may be available under Laws, the arbitral panel shall have no authority to
award provisional remedies of any nature whatsoever, or punitive, special, consequential, or any other similar form of damages.
9.3.6 Each Party shall bear its own costs and attorneys’ fees, and the Parties shall equally bear the fees, costs, and expenses of the arbitrator(s) and the arbitration proceedings; provided, however, that the arbitrator(s) may exercise discretion to award costs, including attorney’s fees, to the prevailing Party.
If to KHL: KYTHERA Biopharmaceuticals, Inc.
00000 Xxxx Xxxxxx Xxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Attention: Xxxxx Xxxxx, Esq., General Counsel
Facsimile: (000) 000-0000
With a copy to: Xxxxxx & Xxxxxxx LLP
000 Xxxxx Xxxxx
Xxxxx Xxxx, XX 00000
Attention: Xxxx Xxxxxxxxx, Esq. and Xxxxxx Xxxxx, Esq.
Facsimile: (000) 000-0000
If to Bayer: Bayer Consumer Care AG
Xxxxx Xxxxxx-Xxxxxx 00
0000 Xxxxx, Xxxxxxxxxxx
Attention: Xxxxxx Xxxxxx
Facsimile: x00 00 000 00 00
With a copy to: Bayer HealthCare Consumer Care
000 Xxxxx Xxxxxxxxx, X.X. Xxx 000
Xxxxxxxx, XX 00000-0000
Attention: Xxxxxxx X. Xxxxxx, Esq., Vice President & Assistant General Counsel
Facsimile: (000) 000-0000
And with a copy to: Xxxxxx & Xxxxxx LLP
000 Xxxxxxx Xxxxxx, X.X.
Xxxxxxxxxx, X.X. 00000
Attention: Xxxxx Xxxxxx, Esq.
Facsimile: (000) 000-0000
If to Kythera: Kythera Biopharmaceuticals, Inc.
00000 Xxxx Xxxxxx Xxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Attention: Xxxxx Xxxxx, Esq., General Counsel
Facsimile: (000) 000-0000
With a copy to: Xxxxxx & Xxxxxxx LLP
000 Xxxxx Xxxxx
Xxxxx Xxxx, XX 00000
Attention: Xxxx Xxxxxxxxx, Esq. and Xxxxxx Xxxxx, Esq.
Facsimile: (000) 000-0000
11.4 Assignment; Change in Control.
11.4.1 Except as otherwise permitted by this Agreement, and subject to the requirements of this Agreement, no Party may assign or transfer this Agreement, or any rights or obligations hereunder without the prior written consent of the other, except that a Party may make such an assignment without the other Party’s consent to (a) any of its Affiliates or (b) a successor in a Change in Control. Any permitted successor or assignee of rights and/or obligations hereunder shall, in writing to the other Party, expressly assume performance of such rights and/or obligations. Any permitted assignment shall be binding on the successors of the assigning Party. Any assignment or attempted assignment by either Party in violation of the terms of this Section 11.4 shall be null, void and of no legal effect.
11.4.2 For clarity, nothing in this Agreement shall restrict KHL or its Affiliates from assigning any right, title or interest in or to any revenues from sales of Products to any Third Party in connection with a monetization transaction, provided that KHL otherwise complies with all the terms and conditions of this Agreement.
11.4.3 KHL shall not assign to any Third Party any intellectual property necessary or useful for the development, manufacture or sale of the Compound or Products unless such Third Party agrees in writing to make all milestone payments set forth in Section 5.3 directly to Bayer that would otherwise be due to Bayer if such intellectual property had not been so assigned and the activities of such Third Party with respect to Compound and Product had been activities of KHL.
of New York, without giving effect to any choice of law principles that would require the application of the laws of a different jurisdiction.
[Signature page follows]
IN WITNESS WHEREOF, the Parties hereto have caused this Assignment and Novation Agreement to be duly executed and delivered in duplicate originals as of the date first above written.
Agreed: |
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BAYER CONSUMER CARE AG | ||
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/s/ Xxxxxx Xxxxxxx |
/s/ Xxxxx Xxxxxxx | |
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By: |
Xxxxxx Xxxxxxx |
Xxxxx Xxxxxxx |
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Title: |
Legal Counsel |
Head CAO |
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Agreed: |
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KYTHERA HOLDINGS LTD. | ||
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/s/ Xxxxx X. Xxxxxxx, Xx. | ||
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By: |
Xxxxx X. Xxxxxxx, Xx. | |
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Title: |
Director | |
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Agreed, solely with respect to Article 2 and Sections 5.3 and 8.4: |
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KYTHERA BIOPHARMACEUTICALS, INC. | ||
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/s/ Xxxxx X. Xxxxxxx, Xx. | ||
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By: |
Xxxxx X. Xxxxxxx, Xx. | |
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Title: |
President and Chief Executive Officer |
[Signature page of Assignment and Novation Agreement]
EXHIBIT A
Securities Purchase Agreement
[provided separately]
EXHIBIT B
Note
[provided separately]
EXHIBIT C
Initial Press Release
[provided separately]
EXHIBIT D
Communication Messages
[provided separately]