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1.	Definitions and Interpretation

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(a)	the MA Transfer Date; or

(b)	ninety (90) days from Closing Date for the US Territory or two (2) years from the Closing Date in the Territory other than the US Territory.

(a)	the approval of the manufacturing (or sourcing from a Third Party) of the Product by Purchaser or its Affiliate or designate; or

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(i)	normal trade and cash discounts;

(ii)	amounts repaid or credited by reasons of defects, rejections, recalls or returns;

(iii)	rebates and chargebacks to customers and Third Parties (including, without limitation, Medicare, Medicaid and Managed Healthcare and similar of rebates);

(iv)	any amounts recorded in gross revenue associated with goods provided to customers for free-with the exception of samples;

(v)	amounts provided or credited to customers through coupons and other discount programs;

(vi)	delayed ship order credits, discounts or payments related to the impact of price increases between purchase and shipping dates;

(vii)	fee for service payments to customers for any non‑separable services (including compensation for maintaining agreed inventory levels and providing information); and

(viii)	other reductions or specifically identifiable amounts deducted for reasons similar to those listed above in accordance with recording Party’s Accounting Standards.

(i)	US Net Sales only include the value charged or invoiced on the first sale to a Third Party and sales between or among the recording Party and its Affiliates and authorized sublicensees shall be disregarded for purposes of calculating US Net Sales; and

(ii)	If a US Product is delivered to the Third Party before being invoiced (or is not invoiced), US Net Sales will be calculated at the time all the revenue recognition criteria under internationally recognized Accounting Standards (such as US GAAP and IRFS) are met.

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(a)	“includes” and “including” shall mean respectively includes and including “without limitation”;

(b)	a Party includes its permitted assignees and/or the respective successors in title to substantially the whole of its undertaking;

(c)	words denoting the singular shall include the plural and vice versa, and words denoting any gender shall include all genders;

(d)	the Exhibits, Annexes and other attachments form part of the operative provision of this Agreement and references to this Agreement shall, unless the context otherwise requires, include references to the Exhibits, Annexes and attachments;

(e)	the headings in this Agreement are for information only and shall not be considered in the interpretation of this Agreement;

(f)	general words shall not be given a restrictive interpretation by reason of their being preceded or followed by words indicating a particular class of acts, matters or things;

(g)	any reference to “writing” or “written” includes faxes and any legible reproduction of words delivered in permanent and tangible form (but does not include email); and

(h)	the Parties agree that the terms and conditions of this Agreement are the result of negotiations between the Parties and that this Agreement shall not be construed in favour of or against any Party by reason of the extent to which any Party participated in its preparation.

(a)

Novartis shall, or shall cause its Affiliates to, with effect as of the Closing, sell, transfer and convey to Purchaser, and Purchaser shall purchase from Novartis and its Affiliates, free and clear of all Encumbrances other than Permitted Encumbrances, all of Novartis’ and its Affiliates’ rights, titles and interests in and to the following and for the avoidance of doubt, in each case solely to the extent exclusively related to the Field in the Territory

(i)	the Marketing Authorizations;

(ii)	the Transferred Commercial Property; and

(iii)	the Transferred Know-How (other than manufacturing processes related to [***]).

(b)	Novartis shall, or shall cause its Affiliates to, with effect as of the Closing, sell, transfer and convey to Purchaser, and Purchaser shall purchase from Novartis and its Affiliates, free and clear of all Encumbrances other than Permitted Encumbrances, all of Novartis’ and its Affiliates’ rights, titles and interests in and to the following:

(i)	the Transferred Intellectual Property;

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(ii)	the Transferred Know-How consisting of manufacturing processes related to [***]; and

(iii)	the [***] Agreements that are assigned by Novartis to Purchaser pursuant to Article 11 below and as set forth in Annex 5 (collectively, the “Transferred [***] Agreements”).

(c)	The assets transferred pursuant to subsections 2.1(a) and 2.1(b) shall be the “Transferred Assets” as used in this Agreement.

(a)	the Licensed IP, subject to the license rights granted to the Purchaser in Clause 3.1;

(b)	the name “Novartis”, “Ciba‑Geigy” or “Sandoz”, or any trademark, service mark, trade dress, logo, trade name, the semi-figurative Novartis house mark or corporate name confusingly similar or related thereto;

(c)	the accounts receivable and the accounts payable, including accruals, prepaid expenses and any cash or cash equivalents of Novartis or any of its Affiliates relating to the Business, the Product or the Transferred Commercial Property for the period prior to the Closing Date;

(d)	any real property or leaseholds (together with all fixtures and fittings related to any property), physical plant, machinery, equipment, motor vehicles or office equipment;

(e)	any rights or assets belonging to the generic business of Sandoz (which is the generic division of Novartis), or any of its successors, containing the Drug Substance, but, for the avoidance of doubt, such rights or assets do not include the assets or rights set forth in Clause 2.1;

(f)	any rights or assets belonging to the business of Alcon (which is a division of Novartis), or any of its successors, containing the Drug Substance, but, for the avoidance of doubt, such rights or assets do not include the assets or rights set forth in Clause 2.1;

(g)	any rights under Novartis’ insurance policies or self‑insurance which are related to the Business;

(h)

originals of books and records that Novartis and/or its Affiliates are required to retain pursuant to any Law, provided however, that (i) Novartis and its Affiliates, as applicable, shall provide copies (redacted to the extent necessary to remove any confidential information not related to the Drug Substance or Product in the Territory) of such books and records upon the Purchaser’s reasonable request and (ii) Novartis and its Affiliates, as applicable, may destroy such books and records in accordance with their prevailing records retention procedures to the extent such books and records are no longer required to be retained by Law so long as Novartis and its Affiliates have previously provided copies of such books and records pursuant to clause (i) of this Clause 2.2(h) after giving Purchaser reasonable opportunity to take possession thereof as provided in Clause 17.3; and

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(i)	any rights or assets, other than the Transferred Assets.

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(a)

any Liabilities arising within or outside the Territory from product liability claims or from patent or trademark infringement claims, actions or lawsuits brought by any Third Party relating to Product or Drug Substance manufactured by or for Purchaser or its Affiliates (or its Third Party collaborators) or sold by Purchaser or its Affiliates (or on their behalf) after the Closing Date (including sales made by Novartis and its Affiliates to Third Parties during the Phase 1 Period as set out in the Supply Agreement) in the Territory; and

(b)	any other Liabilities exclusively related to the Business and Transferred Assets arising from and as a result of events arising after the Closing Date.

(a)

Transfer of Marketing Authorizations. Subject to Clause 5.1(b), Purchaser shall file, or shall cause its Affiliate or designee to file, or, if required by applicable law, Novartis, its Affiliate or designee shall file, applications for the transfer of the Marketing Authorizations for the Product in each country as soon as practicable and in any event no longer than [***] from the Closing Date with respect to all countries in the Territory; provided, however, that in the European countries, the Purchaser shall use its commercially reasonable efforts to file for the transfer of the Marketing Authorizations within [***] from the Closing Date. Purchaser shall provide Novartis with a detailed action submission plan for the transfer of the Marketing Authorizations for the Product (the “Marketing Authorization Plan”) within [***] from the Closing Date. The Marketing Authorization Plan shall include all requirements and actions necessary, to obtain approval of the Marketing Authorization transfer by the Regulatory Authorities in each country in the Territory (including, but not limited to, the establishment of the Purchaser’s Affiliate or local agent, requirements of a Certificate of the Pharmaceutical

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(b)

Non-transferred Marketing Authorizations. Within [***] after the Closing Date, Purchaser shall inform Novartis in writing of any Marketing Authorizations or approvals for manufacturing that Purchaser does not intend to transfer (each a “Non‑transferred Marketing Authorization”).  Upon receiving notice of such Non‑transferred Marketing Authorizations, Novartis shall deregister all such Non‑transferred Marketing Authorizations as soon as practicable and shall, thereafter cease all shipments of the Product to all locations within the relevant countries as soon as feasible; provided that (i) where the deregistration of a Marketing Authorization is not possible from a legal, regulatory or reputational perspective, Purchaser shall still be required to file for the transfer of the Marketing Authorizations in accordance with Clause 5.1(a) above; for the avoidance of any doubt, such Marketing Authorization shall not be deemed to be a Non-transferred Marketing Authorization, (ii) Purchaser shall reimburse Novartis for any write-offs of Inventory resulting from such deregistration and the parties shall cooperate to minimize any such write-offs and (iii) Purchaser shall bear the Third Party fees levied by applicable Regulatory Authorities and Governmental Entities and any other out of pocket costs regarding the deregistration of any Non-transferred Marketing Authorizations.

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(a)

Transfer of Patents and Trademarks and Registered Designs. Within [***] Business Days after the Closing Date, Novartis shall execute and deliver to Purchaser, the IP Assignment Agreements. Upon receipt by Purchaser of the IP Assignment Agreements, Purchaser will promptly execute the IP Assignment Agreements, and Purchaser shall be responsible for filing the IP Assignment Agreements with the relevant Intellectual Property registries at its sole cost and expense, including all filing costs and external fees. Other than its obligations under Clause 5.5(c), Novartis’ sole obligation with regards to the transfer of the Transferred Intellectual Property consisting of Patents and Trademarks and Registered Designs will be to properly execute the IP Assignment Agreements and any other documents required to register the transfer of such Intellectual Property in the Territory and to assist with related formalities (including executing forms suitable for recording in all jurisdictions where such Intellectual Property is registered in the Territory to the extent such jurisdiction requires terms and conditions that differ from the relevant IP Assignment Agreements).

(b)

Transfer of Domain Names. Within [***] Business Days after the Closing Date, Novartis shall execute and deliver to Purchaser the Domain Name Assignment Agreements. Upon receipt by Purchaser of the Domain Name Assignment Agreements, Purchaser will promptly execute the Domain Name Assignment Agreements. The current Novartis administrator of the domain names to be assigned thereunder shall be responsible for filing the requisite requests and any required Domain Name Assignment Agreement with the relevant domain name registrar at the sole costs and expenses of Novartis, including all filing costs, and external fees.

(c)

As soon as practicable after the Closing Date, Novartis will deliver to Purchaser a complete and accurate list of all actions that must be taken by Purchaser within [***] days of the Closing Date with respect to each Patent, Trademark and Registered Design included in the Transferred Intellectual Property. As soon as practicable after the Closing, but in no event later than [***] days after the Closing, Novartis shall deliver to Purchaser correct and complete copies (in the possession or form currently maintained by Novartis and/or its Affiliates (or their representatives)) of all prosecution and opposition files and dockets, registration certificates, litigation files and related opinions of counsel and correspondence relating thereto for the Patents, Trademarks and Registered Designs included in the Transferred Intellectual Property, provided that this sentence shall not be deemed to apply to documents or other items, the disclosure of which would jeopardize the attorney-client privilege.

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(a)	supplying, selling, distributing and invoicing customers for the Product in the Territory during [***];

(b)	supplying the Product to the Purchaser in accordance with the Supply Agreement;

(c)	providing Purchaser with all existing regulatory documentation concerning the Product in the Territory, in the form currently maintained in the Books and Records of Novartis and/or its Affiliates, and that is owned or controlled by Novartis and reasonable general assistance for (but not to undertake) the transfer of the Marketing Authorizations;

(d)	providing Purchaser with all existing documentation owned or controlled by Novartis in the Field, in the form currently maintained in the Books and Records of Novartis and/or its Affiliates, describing manufacturing processes for Product or Drug Substance in detail and reasonable general technical advice for the transfer of the manufacturing process of the Product and the Drug Substance;

(e)	for all work deemed over and above that is described in subparagraph (c) above, upon reasonable written request from Purchaser, and at Purchaser’s expense, providing regulatory assistance to facilitate the transfer of the Marketing Authorizations from Novartis and/or its Affiliates; and

(f)	for all work deemed over and above that described in subparagraph (d) above, upon reasonable written request from Purchaser and subject to the agreement of Novartis (such agreement not to be unreasonably withheld, delayed or conditioned), and at Purchaser’s

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(a)	Novartis shall use its commercially reasonable efforts to maintain the Marketing Authorizations;

(b)	Novartis shall be free to continue to pursue those on‑going variations, amendments and renewals which are pending at the Closing Date, or withdraw them, in each case, if mutually agreed to by Novartis and Purchaser; and

(c)	Novartis shall not be required to initiate any additional variations or amendments, except in the event they are indispensable for the continuation of the Business and required by Regulatory Authorities.

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(a)	$110,000,000 (one hundred and ten million United States Dollars) of the Purchase Price on the Closing Date (less the [***] payments of [***] made to Novartis) (the “Closing Payment”); and

(b)	$89,000,000 (eighty nine million United States Dollars) on the first anniversary of the Closing Date (the “Anniversary Payment”). $75,000,000 of the Anniversary Payment shall be covered by an irrevocable bank guarantee in favour of Novartis issued on the Closing Date [***].

(c)	Milestone #1: If no generic has been launched in the USA market by [***] then a [***] milestone is payable within five (5) Business Days of [***];

(d)	Milestone #2: If the cumulative [***], from the Closing Date, Product US Net Sales in the USA are equal or greater than [***] then a [***] milestone is payable within five (5) Business Days of the end of the [***] of the Closing;

(e)	Milestone #3: If the cumulative [***], from the Closing Date, Product US Net Sales in the USA are equal or greater than [***] then a [***] milestone is payable within five (5) Business Days of the end of the [***] of the Closing in addition to Milestone #2; and

(f)	Milestone #4: If no generic product containing aliskiren has been launched in the USA market by [***] then a [***] milestone is payable within five (5) Business Days of [***].

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(a)	Transfer Taxes. Purchaser shall bear any Transfer Tax imposed in the Territory in connection with the transactions contemplated in this Agreement and shall make any corresponding tax declarations in the Territory that may be required.

(b)	Tax Obligations. Each Party shall be responsible for any tax obligations of its own due to this Agreement (including income tax and capital gains tax). Neither Party shall have any obligation towards the other Party in case the other Party fails to fully comply with its tax obligations.

(c)	Reporting. For all tax purposes, both Parties agree to report the transactions contemplated by this Agreement in a manner consistent with its terms and to not take any position inconsistent therewith in any Tax Return, refund claim, litigation, or otherwise.

(a)	Any applicable waiting period (and any extension thereof) or consent required under any applicable antitrust Law relating to the transactions contemplated by this Agreement shall have expired or been terminated or obtained, as applicable.

(b)	No Governmental Entity shall have enacted, issued, promulgated, enforced or entered any Law or order that is in effect and would (i) make the Closing illegal or (ii) otherwise prevent or enjoin the transactions contemplated by this Agreement.

(c)	Since the date of this Agreement, no Material Adverse Effect shall have occurred and be continuing as of the Closing Date.

(d)	The Parties shall have delivered all of the deliverables set forth in this Article 10, in the case of the deliverables set forth in Clause 10.6(c), in the form currently maintained in the Books and Records of Novartis and/or its Affiliates, if applicable.

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(a)	agree with the Purchaser how and when to transfer to Purchaser or its Affiliates or designates:

(i)	Marketing Authorization Data which are in Novartis’ or its Affiliates’ possession; and

(ii)	the Marketing Authorizations (by way of an appropriate submission to the relevant Regulatory Authorities); and

(b)	otherwise co-operate with the Purchaser to facilitate the smooth implementation of this Agreement.

(a)	an amount equal to the Closing Payment, by wire transfer of immediately available funds to an account of Novartis designated in writing by Novartis to Purchaser at least three (3) Business Days prior to the Closing Date;

(b)	a certificate duly executed by an authorized officer of Purchaser, dated as of the Closing Date, certifying that:

i.	Purchaser has performed in all material respects all of the covenants and agreements required to be performed by it pursuant to this Agreement prior to the Closing; and

ii.

(1) each of the representations and warranties of Purchaser contained herein (other than those representations and warranties contained in Clauses 13.1(c) and 13.1(e)) shall be true and correct in all material respects on and as of the date of this Agreement and on and as of the Closing Date and (2) each of the representations and warranties of Purchaser contained herein that are qualified by materiality, Material Adverse Effect, or similar phrases and those representations and warranties contained in Clauses 13.1(c) and 13.1(e) shall be true and correct in all respects on and as of the date of this Agreement and on and as of the Closing Date (except, in each case, to the extent such representations and warranties address matters as of particular dates, in which case, such representations and warranties shall be true and correct in all material respects or in all respects, as the case may be on and as of such dates);

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(c)	a counterpart of each Ancillary Agreement to which Purchaser or any of its Affiliates is a party, duly executed on behalf of Purchaser or such Affiliates;

(d)	the irrevocable bank guarantee for $75,000,000 of the Anniversary Payment as required by Clause 9.2(b);

(e)	an irrevocable guarantee for $14,000,000 of the Anniversary Payment by PDL as required by Clause 9.2(b); and

(f)	such other documents or instruments Novartis reasonably request and are reasonably necessary or advisable to consummate the transactions contemplated by this Agreement.

(a)	a certificate duly executed by an authorized officer of each of NAG and NPAG, dated as of the Closing Date, certifying that:

(i)	Novartis has performed and complied with in all respects all of the covenants and agreements required to be performed by it pursuant to this Agreement prior to the Closing; and

(ii)

(1) each of the representations and warranties of Novartis set forth in Clauses 12.1(a), (b), (e), (h), (i) and (j) shall be true and correct in all material respects on and as of the date of this Agreement and on and as of the Closing Date and (2) each of the other representations and warranties of Novartis shall be true and correct (without regard to any qualification as to materiality or Material Adverse Effect included therein) as of the date of this Agreement and on and as of the Closing Date (except, in each case, to the extent such representations and warranties address matters as of particular dates, in which case, such representations and warranties shall be true and correct in all material respects or in all respects, as the case may be, on and as of such dates);

(b)	a counterpart of each Ancillary Agreement to which Novartis is a party, duly executed on behalf of Novartis;

(c)	within [***] of the Closing, a complete copy of the files provided to Purchaser in the dataroom (excluding those agreements with Third Parties subject to confidentiality restrictions) and Novartis shall maintain the dataroom in its current form, which shall be accessible to Purchaser [***] days following the Closing; and

(d)	as soon as reasonably practicable following the Closing, all Transferred Commercial Property and Books and Records; provided that, in the event that prior to such delivery, if Purchaser makes a specific request for an item of Commercial Property or Books and Records, Novartis will reasonably cooperate with Purchaser to provide such item promptly.

(a)	Novartis shall use its commercially reasonable efforts to cooperate with the Purchaser and provide its independent auditor (the “Independent Auditor”) with the relevant

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(b)	Notwithstanding the foregoing, nothing in this Clause 10.7 shall require such information, cooperation or assistance to the extent it would have a Material Adverse Effect on the Business or the other businesses or operations of Novartis or its Affiliates.

(c)	The Purchaser shall support Novartis to identify the scope of work and to allow Novartis to provide the required statements and information to the Independent Auditor in a timely manner.

(d)	[***]

(a)	Organization of Novartis. Each of NAG, NPAG and Speedel is duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization;

(b)	Authorization. Each of NAG, NPAG and Speedel have the capacity to enter into this Agreement and the Ancillary Agreements, have obtained all required internal approvals from its board of directors, management committee or any other internal committee, and

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(c)

Consents and Approvals. Except as would not reasonably be expected to be material to the Business, (a) no notice to, declaration, filing or registration with, or authorization, consent or approval of, any Person, and (b) no consent under any contract from any other Person, is, in each case, required to be made or obtained by NAG, NPAG and Speedel or any of their respective Affiliates in connection with the transfer of such contract to Purchaser hereunder or the execution, delivery and performance of this Agreement and the Ancillary Agreements to which NAG, NPAG or Speedel is a party and the consummation of the transactions contemplated hereby and thereby.

(d)

No Conflict or Violation. Neither the execution, delivery or performance of this Agreement or the Ancillary Agreements, nor the consummation of the transactions contemplated hereby or thereby, nor compliance by NAG, NPAG and Speedel with any of the provisions hereof or thereof, will (i) violate or conflict with the organizational documents of NAG, NPAG and Speedel or, to the Knowledge of Novartis and except as would not reasonably be expected to be material to the Business, (ii) violate, conflict with, or result in or constitute a default under, or result in the termination of, or accelerate the performance required by, or result in a right of termination or acceleration, or result in the creation of any Encumbrance, restriction or limitation on use upon or with respect to any of the Transferred Assets (other than Permitted Encumbrances) under any of the terms, conditions or provisions of any contract (i) to which NAG, NPAG or Speedel is a party or (ii) by which any Transferred Assets of NAG, NPAG or Speedel are bound, (iii) violate any Law or order, or (iv) contravene, conflict with, or result in a violation of any of the terms or requirements of, or give any Governmental Entity the right to revoke, withdraw, suspend, cancel, terminate or modify any Permits which constitute Transferred Assets.

(e)	Title to and Sufficiency of Assets.

(i)	Novartis and/or its Affiliates (as applicable) are the legal and beneficial owners of the Transferred Assets and upon the consummation of the transactions contemplated hereby, Purchaser and/or its Affiliates will acquire good and valid title to all of the Transferred Assets, free and clear of any Encumbrances, restrictions or limitations on use, other than Permitted Encumbrances.

(i)	The Transferred Assets constitute all of the material assets of Novartis (other than assets the access to which is provided under the Transition Services Agreement in accordance with the express terms and the Licensed IP) necessary and sufficient for the operation of the Business by Novartis in the Field as the same is operated on the Closing Date.

(f)	Litigation. There is and has been no suit, action, investigation or proceeding pending or threatened in writing by or against Novartis within the last [***] that (i) except as set

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(g)	Compliance with Laws.

(i)

To the Knowledge of Novartis, in conjunction with the manufacture, marketing, distribution and sale of the Product in the Field by Novartis, Novartis is in compliance in all material respects with all applicable Laws and has all required Permits. To the Knowledge of Novartis on the Closing Date, Novartis, has not received any written notice of any asserted material violation of any applicable Laws in connection with the manufacture, marketing, distribution and sale of the Product in the Field by Novartis.

(ii)	To the Knowledge of Novartis, the Marketing Authorizations are in force to the extent required by Law.

(h)	Intellectual Property.

(i)	Registered Intellectual Property. Annex 1 sets forth an accurate and complete list of the registered and applied-for internet domain names, Patents, Trademarks and Registered Designs owned and/or controlled (whether solely or jointly with others) by Novartis and/or its Affiliates as of the Closing that are included in the Transferred Intellectual Property.

(ii)

Title to Intellectual Property. Novartis exclusively owns all right, title and interest in and to all Transferred Intellectual Property and the Transferred Know‑How, free and clear of all Encumbrances, and none of the Transferred Intellectual Property is subject to any license agreement, covenant not to sue, settlement agreement or any other similar agreement. All maintenance and renewal fees have been paid with respect to all registered Transferred Intellectual Property, and, to the Knowledge of Novartis, all registered Transferred Intellectual Property is enforceable. For the avoidance of doubt, the Patents included in the Transferred Intellectual Property shall include all related Priority Patents.

(iii)	Development and Assignment of Intellectual Property. Novartis and its Affiliates have taken reasonable precautions to preserve the confidentiality of the Transferred Know-How.

(iv)

Sufficiency of Intellectual Property. The Transferred Intellectual Property, the Transferred Know-How and the Licensed IP constitute all of the Intellectual Property and Know-How that is necessary and sufficient to conduct the Business in the Field as it is currently conducted by Novartis. As of the Closing Date, Purchaser will own all of the tangible embodiments of the Transferred Intellectual Property, Transferred Know-How and all other documentation Novartis currently uses to conduct the Business.

(v)	Transferability of Intellectual Property. The Transferred Intellectual Property and the Transferred Know-How are, and following the Closing Date will be, fully transferable, alienable and licensable without restriction and without payment of any kind to any Person other than fees in relation to the assignment of the

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(vi)

No Infringement. To the Knowledge of Novartis, the development, manufacture, use, sale, import, export, distribution, marketing, licensing or other disposal, exploitation or commercialization of the Product or the Drug Substance in the Field does not infringe upon, misappropriate or violate, and has not infringed upon, misappropriated or violated, any Intellectual Property or Know-How of any Person (directly or indirectly, including by contribution or inducement), nor does it constitute or has constituted unfair competition or trade practices under the Laws of any jurisdiction, and Novartis has not received, in connection with the Business in the Field, any notice of infringement, misappropriation or violation of the Intellectual Property or Know-How of any Person or unfair competition or trade practices (including cease and desist letters, indemnification claims or invitations to license). To the Knowledge of Novartis, no Person is infringing, misappropriating or otherwise violating any Transferred Intellectual Property or Transferred Know-How.

(vii)

Actions Brought By Third Parties. No claim, action, suit, litigation or proceeding is pending or, to the Knowledge of Novartis, threatened, against Novartis by any Person, (a) alleging that the development, manufacture, use, sale, import, export, distribution, marketing, licensing or other disposal, exploitation or commercialization of the Product or the Drug Substance in the Field as currently conducted or as had been conducted during the past [***] infringes, misappropriates or otherwise violates, or has infringed, misappropriated or otherwise violated, any Intellectual Property or Know-How of any Person or seeking indemnification for any of the foregoing, (b) claiming that the Business in the Field has been conducted in a manner constituting unfair competition or an unfair trade practice or (c) seeking cancellation of, objecting to, opposing or challenging the ownership, validity, registerability or enforceability of any item of Transferred Intellectual Property.

(viii)

Actions Against Third Parties. No claim, action, suit, litigation or proceeding is pending or threatened by Novartis against any Person alleging (a) infringement, misappropriation or other violation of any of the Transferred Intellectual Property or Transferred Know‑How or (b) breach of any license, sublicense or other agreement authorizing such Person to use any of the Transferred Intellectual Property or Transferred Know‑How.

(i)

Transferred Third Party Agreements. Each of the Transferred Third Party Agreements constitutes a legal, valid and binding obligation of Novartis in accordance with its terms and, to the Knowledge of Novartis, constitutes a legal, valid and binding obligation of the other parties thereto in accordance with its terms, and is enforceable against Novartis and the other parties thereto, in accordance with its terms. Novartis is [***] and no condition, event or fact exists which, with notice, lapse of time or both, would reasonably be expected to [***]. Novartis has not received any written notice alleging any violation, breach or default by Novartis under any Transferred Third Party Agreement.

(j)	Taxes.

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(i)	Payment, Claims and Returns. Except for taxes that are not yet due or payable, there are no liens for taxes with respect to the Transferred Assets.

(ii)	Real Property. None of the Transferred Assets include any “United States real property interest” within the meaning of Section 897(c)(1) of the Internal Revenue Code of 1986, as amended.

(iii)

Residency. Novartis is beneficially entitled to the Purchase Price payable to it under this Agreement, and it is (i) a body corporate which is, by virtue of the laws of Switzerland, resident for the purposes of tax in Switzerland, and Switzerland imposes a tax that generally applies to royalties receivable in that territory by companies from sources outside that territory; (ii) not resident in Ireland for tax purposes; and (iii) the Purchase Price is not received by it in connection with a trade or business which is carried on in Ireland through a branch or agency in Ireland. Novartis shall promptly inform the Purchaser in the event that this representation ceases to be correct prior to the payment of the final installment of the Purchase Price.

(a)	Business Operations.

(i)	Purchaser is a pharmaceutical company which, together with its Affiliates and distributors, has the necessary technical and commercial resources and expertise to take over from Novartis the Business in each country of the Territory under the terms, conditions and timelines contained in this Agreement and the Supply Agreement; and

(ii)	Purchaser has or will have, as of the date of the filing for the transfer of a Marketing Authorization in the applicable country, Affiliates or distributors in each country of the Territory that meet all requisites mentioned in subparagraph (i) above, under the terms, conditions and timelines contained in this Agreement and the Ancillary Agreements.

(b)	Litigation.

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(i)	Purchaser is not and has not been (and has no Affiliates that are or have been) subject to any litigation by customers or investigation by local and/or Regulatory Authorities which would negatively impact a smooth transfer of the Business to Purchaser and its Affiliates; and

(ii)	There is no suit, action, investigation or legal proceeding pending or threatened in writing against the Purchaser that challenges or seeks to prevent or enjoin the transactions contemplated by this Agreement.

(c)	Knowledge.

(i)	There is no information concerning the Business which Novartis has provided prior to the date hereof that, to the Knowledge of Purchaser, is untrue or incorrect; and

(ii)	Purchaser is not aware of any grounds for a valid basis for bringing a Warranty Claim against Novartis under this Agreement.

(d)	Organization of Purchaser. Purchaser is a valid legal entity duly constituted, organised and existing under the laws of the jurisdiction of its formation.

(e)

Authorization. Purchaser has the capacity to enter into this Agreement and the Ancillary Agreements, has obtained all required internal approvals from its board of directors, management committee and/or any other internal committee and has taken all action necessary to execute and deliver this Agreement and the Ancillary Agreements to which it is a party, to consummate the transactions contemplated hereby and thereby and to perform its obligations hereunder and thereunder. This Agreement has been duly executed and delivered by Purchaser and is, and upon execution and delivery of the Ancillary Agreements to which it is a party, each of such Ancillary Agreements will be, legal, valid and binding obligations of Purchaser enforceable against Purchaser in accordance with their terms.

(f)

Commercialization. To the Knowledge of Purchaser, (i) Purchaser has not been debarred under Subsection (a) or (b) of Section 306 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 335a); (ii) no Person who, to the Knowledge of Purchaser, has been debarred under Subsection (a) or (b) of Section 306 of said Act will be employed by the Purchaser in the performance of any activities hereunder; and (iii) to the Knowledge of Purchaser, no Person on any of the FDA clinical investigator enforcement lists (including, but not limited to, the (1) Disqualified/Totally Restricted List, (2) Restricted List and (3) Adequate Assurances List) will be employed by Purchaser in the performance of any activities hereunder.

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(a)

Each of the representations and warranties set forth in this Agreement or any certificate or other instrument, delivered by or on behalf of a Party pursuant to this Agreement, shall survive the Closing until the [***] of the Closing Date; provided, however, that the representations and warranties set forth in (i) Clauses 12.1(a), (b) and (e)(i), as well as Clauses 13.1(d) and 13.1(e), shall survive (together with any right to assert a Claim under Clause 15.1(a)) [***] and (ii) Clauses 12.1(j) shall survive (together with any right to assert a Claim under Clause 15.1(a)) until [***] (the representations and warranties specified in clauses (i) and (ii) of this Clause 14.2(a) the “Specified Representations”).

(b)	Each of the covenants and other agreements contained in this Agreement or any certificate or other instrument delivered by or on behalf of a Party pursuant to this Agreement shall survive (together with any right to assert a Claim under Clause 15.1(b) or Clause 15.2(b)) the Closing and the consummation of the transactions contemplated hereby until the expiration of its term.

(c)	Notwithstanding anything to the contrary herein, any Claim that is properly asserted in good faith pursuant to Clause 15.3 prior to the expiration of the applicable survival period set forth in Clause 14.2(a) or Clause 14.2(b) shall survive, and the applicable survival period shall be extended, until such Claim is fully and finally resolved.

(a)	The aggregate Liability of Novartis for all Claims of Purchaser Indemnitees under Clause 15.1(a) (other than those based upon, resulting from, arising out of or relating to Clause 12.1(j)) shall be limited to [***]

(b)

Novartis shall not be liable for any Claim of Purchaser Indemnitees under Clause 15.1(a) unless and until the aggregate amount of all Losses in respect of indemnification under Clause 15.1(a) (other than those based upon, resulting from, arising out of or relating to the Specified Representations) exceeds [***] (the “Seller Indemnification Threshold”), and only the Losses in excess of the Seller Indemnification Threshold shall be recoverable hereunder.

(c)	The aggregate Liability of Purchaser for all Claims of Seller Indemnitees under Clause 15.2(a) shall be limited to [***].

(d)	Purchaser shall not be liable for any Claim of Seller Indemnitees under Clause 15.2(a), unless and until the aggregate amount of all Losses in respect of indemnification under Clause 15.2(a) exceeds [***] (the “Purchaser Indemnification Threshold”), and only the Losses in excess of the Purchaser Indemnification Threshold shall be recoverable hereunder.

(e)	In no event shall Purchaser or Novartis be liable in connection with this Agreement or the transactions contemplated hereby for any Losses that are punitive, incidental, consequential, special or indirect, including breaches of the confidentiality provisions in Clause 17.

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(a)	any inaccuracy in or breach of any representation or warranty of Novartis contained in this Agreement or in any certificate or other instrument delivered by or on behalf of Novartis pursuant to this Agreement;

(b)	any breach of any covenant, agreement or obligation to be performed by Novartis and/or any of its Affiliates pursuant to this Agreement or any Ancillary Agreement;

(c)	any Excluded Asset or Excluded Liability; and

(d)

any Losses attributable to (i) Pre-Closing Taxes and (ii) all taxes imposed on Novartis (other than taxes with respect to Transferred Assets attributable to a taxable period or portion thereof beginning after the Closing Date), including income, franchise, net gain or similar taxes imposed on Novartis as a result of the sale, conveyance, assignment, transfer or delivery of the Transferred Assets and Assumed Liabilities pursuant to this Agreement.

(a)	any Transferred Asset or Assumed Liability, except to the extent subject to an indemnification obligation of Novartis;

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(b)	any inaccuracy in or breach of any representation or warranty of Purchaser contained in this Agreement or in any other certificate or instrument delivered by or on behalf of Purchaser pursuant to this Agreement; and

(c)	any breach of any covenant, agreement or obligation to be performed by Purchaser pursuant to this Agreement or any Ancillary Agreement.

(a)	All claims pursuant to this Article 15 (a “Claim”) shall be made in accordance with the procedures set forth in this Clause 15.3. The indemnified party submitting a Claim pursuant to Article 14 and 15 (an “Indemnified Party”) shall:

(i)	promptly notify the indemnifying party (the “Indemnifying Party”) of any action, suit or proceeding, or threatened claim, action or proceeding, which could lead to a Loss;

(ii)

with respect to any Claim in connection with any claim, action, suit or proceeding by a Third-Party (a “Third-Party Claim”), upon request by the Indemnifying Party, permit the Indemnifying Party to take full care and control of the conduct, defence and settlement of such claim, action or proceeding at the Indemnifying Party’s expense with counsel of its choosing that is reasonably satisfactory to the Indemnified Party, and the Indemnified Party shall cooperate in good faith in such defense; provided, however, that the Indemnifying Party shall not compromise or otherwise settle any such claim, action or proceeding without the prior written consent of the Indemnified Party, which consent shall not be unreasonably withheld, delayed or conditioned;

(iii)	reasonably assist, at the cost of the Indemnifying Party, in the investigation and defence of such claim, action or proceeding;

(iv)	not compromise or otherwise settle any such claim, action or proceeding without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld, delayed or conditioned; and

(v)	take all reasonable steps to mitigate any Loss in respect of any such claim, action or proceeding.

(b)	The Indemnified Party or Indemnifying Party, as the case may be, that is not controlling such defense shall have the right, at its own cost and expense, to participate in the defense of any Third‑Party Claim.

(a)	The amount of Loss for which indemnification is provided under Articles 14 and 15 shall be net of any amounts actually recovered by the Indemnified Party under insurance policies or from other Third Parties with respect to such Loss.

(b)	The Parties agree to treat any indemnification payments pursuant to Articles 14 and 15 as an adjustment to the Purchase Price solely for tax purposes, unless otherwise required by applicable Law.

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(a)	in case the other Party has committed a material breach and has failed to remedy such breach within [***] days from having received a written request to remedy such breach from the non-breaching Party;

(b)	by mutual written consent of Novartis and Purchaser; or

(c)

upon written notice to the other Party, if the transactions contemplated by this Agreement have not been consummated solely due to continued review by a Governmental Entity in respect of applicable antitrust Laws on or prior to 11:59 p.m., New York, New York time, on August 22, 2016 or such later date, if any, as Novartis and Purchaser agree upon in writing; provided that no Party may terminate the Agreement pursuant to this Clause 16.1(c) if such Party’s breach of the Agreement causes or results in the failure of the transactions contemplated by this Agreement; or

(d)	upon written notice to the other Party, if a Governmental Entity of competent jurisdiction has issued an order or any other action permanently enjoining or otherwise prohibiting the consummation of the transactions contemplated by this Agreement.

(a)	The Confidentiality Agreement shall be deemed incorporated herein by reference as if set forth herein and shall continue in full force and effect until the Closing, unless this Agreement is terminated prior to the Closing, in which case the Confidentiality Agreement shall nonetheless continue in full force and effect in accordance with its terms.

(b)

From and after the Closing, Novartis shall keep confidential and not disclose any non-public information to any Third Party concerning the Transferred Assets and Purchaser shall keep confidential and not disclose any non-public information to any Third Party concerning the Licensed IP, and each Party agrees to not disclose other non-public information of the other Party as it has received or will receive pursuant to this Agreement; provided that either Party may disclose any non-public information concerning the Transferred Assets, in the case of Novartis, or the Licensed IP, in the case of Purchaser, or such other non-public information that it has or will receive pursuant to

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(i)	required to protect such Party’s or its Affiliates interest in any legal proceedings;

(ii)	required to a Tax Authority in connection with the tax affairs of such Party or any of its Affiliates;

(iii)	disclosure is made to such Party or its Affiliates professional advisers on a need-to-know basis; provided that such professional advisers are subject to professional confidentiality obligations;

(iv)	the information is or becomes publicly available (other than by breach of this Agreement),

(v)	the use or disclosure of the relevant information to a competent Regulatory Authority, Governmental Entity or Third Party is required by applicable Law, court order or order of such Regulatory Authority or Governmental Entity or in connection with such Party’s or its Affiliates’ obligations under this Agreement or any Ancillary Agreement;

(vi)	the information is disclosed to such Party or any of its Affiliates by a Third Party who is entitled to disclose it without breaching a confidentiality obligation to the other Party or its Affiliates; or

(vii)	is disclosed with the express written consent of the Party owning such non-public information.

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(a)

Neither Party may assign its rights and obligations under this Agreement without the other Party’s prior written consent (such consent not to be unreasonably withheld, delayed or conditioned), except that either Party may (a) assign its rights and obligations under this Agreement or any part hereof to one or more of its Affiliates without the consent of the other Party; provided, that (i) all applicable terms and provisions of this Agreement shall apply to any such Affiliate to the same extent as such terms and provisions apply to the respective Party to this Agreement, (ii) each Party shall remain primarily liable for any acts or omissions of its Affiliates and (iii) any breach by an Affiliate of a Party shall be deemed to be a breach by such Party; and (b) assign this Agreement in its entirety to a successor to all or substantially all of its business or assets to which this Agreement relates. Any permitted assignee shall assume all obligations of its assignor under this Agreement (or related to the assigned portion in case of a partial assignment to an Affiliate), and no permitted assignment shall relieve the assignor of Liability hereunder. Any attempted assignment in contravention of the foregoing shall be void.

(b)	Purchaser may grant a security interest in respect of this Agreement or any Ancillary Agreement in its entirety or any part thereof in favor of a debt financing source, without the prior written consent of Novartis. Purchaser shall provide ten (10) days’ prior written notice to Novartis in the case of any such assignment.

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Email:	rlincer@cgsh.com

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Email:	rlincer@cgsh.com

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