AMENDED AND RESTATED WORLDWIDE AGREEMENT

 

NOW, THEREFORE, in consideration of the premises and the mutual promises and covenants set forth below, PDL and Roche mutually agree to amend and restate the 1999 Agreements in this single Amended and Restated Worldwide Agreement as follows:

 

I.  DEFINITIONS

 

For the purposes of this Amended and Restated Worldwide Agreement, the following terms, when written with an initial capital letter, shall have the meaning ascribed to them below.  All references to particular Appendices, Articles and Sections shall mean the Appendices to, and Articles and Sections of, this Amended and Restated Worldwide Agreement, unless otherwise specified.

 

1.1                                 “AAGS” shall mean the average annualized Roche Adjusted Gross Sales of Daclizumab calculated according to the following:

 

[*]

 

where [*] is the [*] for the period from [*] through the most recent [*] ended [*] the [*] of (i) the date of [*] that [*] the [*]; or (ii) the date of [*] that [*] the [*];

 

[*] is that portion of [*] that [*], to [*] reasonable satisfaction, to be [*] to [*] for [*] in [*] or [*]; and

 

[*] is the [*] of [*] from (and including) [*] through the end of the [*] ended [*] to the [*] of (i) the date of [*] that [*] the [*]; or (ii) the date of [*] that [*] the [*].

 

By way of illustration and without limitation, [*]

 

1.2                                 “Acting Party” has the meaning set forth in Section 12.1(c).

 

1.3                                 “Affiliates” means any corporation or other business entity controlled by, controlling, or under common control with another entity, with “control” meaning direct or indirect beneficial ownership of more than fifty percent (50%) of the voting stock of, or more than a fifty percent (50%) interest in the income of, such corporation or other business entity.  Anything to the contrary in this paragraph notwithstanding, [*]

 

1.4                                 “AI Trademarks” means all trademarks used in connection with the marketing, promotion, and sale of Daclizumab by PDL or its sublicensee(s) and all trademark registrations and applications therefor, and all goodwill associated therewith.

 

1.5                                 “Application” means a new application, or a supplement or an amendment to an existing application, for marketing approval for an Autoimmune Indication in the Territory.

 

1.6                                 “Autoimmune Indications” or “AI” means all indications that involve pathogenic consequences, including tissue injury, produced by autoantibodies or autoreactive T lymphocytes interacting with self epitopes, i.e., autoantigens.  Autoimmune Indications shall

 

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include, without limitation, asthma, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, juvenile rheumatoid arthritis, polymytosis, Type I diabetes, sarcoidosis, Sjogrens syndrome, chronic active non-pathogenic hepatitis, non-infectious uveitis (Behcets), aplastic anemia, regional non-pathogenic enteritis (including ulcerative colitis, Crohn’s Disease and inflammatory bowel disease), Kawasaki’s disease, post-infectious encephalitis, multiple sclerosis, and tropic spastic paraparesis.

 

1.7                                 “Change of Control” means a transaction in which Roche either (a) sells, conveys or otherwise disposes of all or substantially all of its property or business; or (b) either (i) merges or consolidates with any other entity (other than a wholly-owned subsidiary of Roche); or (ii) effects any other transaction or series of transactions, in each case of clause (i) or (ii), such that the voting stockholders of Roche immediately prior thereto, in the aggregate, no longer own, directly or indirectly, beneficially or legally, at least fifty percent (50%) of the outstanding voting securities or capital stock of the surviving entity following the closing of such merger, consolidation, other transaction or series of transactions.

 

1.8                                 “Combination Product” means any product containing both an ingredient that causes it to be considered a Licensed Product and one or more other therapeutically active ingredients.

 

1.9                                 “Commercialization Term” means the period commencing on the Effective Date and ending on the earliest of (a) the Reversion Effective Date; (b) the Put Right Effective Date; and (c) if Roche does not exercise the Roche Put Right and the Exercise Period ends without PDL exercising the Transplant Reversion, the date Roche ceases to sell Daclizumab in every country in the Roche Territory, as permitted under this Amended and Restated Worldwide Agreement.

 

1.10                           “Controlled” means, with respect to any intellectual property right, that the party has a license to such intellectual property right and has the ability to grant to the other party a sublicense to such intellectual property right as provided for herein without violating the terms of any agreement or other arrangements with any Third Party existing at the time such party would be first required hereunder to grant the other party such sublicense.

 

1.11                           “Cost of Goods” means the manufacturing cost of either (a) unformulated bulk Daclizumab, or (b) finished Daclizumab product made from unformulated bulk, as the case may be, calculated in accordance with internal cost accounting methods consistently applied by a party for its other biologics pharmaceutical products, provided that such methods comply with [*].  Cost of Goods shall include [*]. As used in this Amended and Restated Worldwide Agreement, the Cost of Goods shall not exceed [*]

 

1.12                           “Cover” (including variations thereof such as “Covering” or “Covered”), means that the manufacture, use, sale, offer for sale, or importation of a particular product would infringe a Valid Claim of a patent in the absence of rights under such patent.  The determination of whether a particular product is Covered by particular Valid Claims shall be made on a country-by-country basis.

 

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1.13                           “Daclizumab” means any product that contains humanized anti-Tac (as defined under “Field”).

 

1.14                           “Daclizumab Assets” means all assets owned by Roche or its Affiliates and relevant solely to the development or commercialization of Daclizumab, other than the Trademarks and the Roche Owned Patents.  Daclizumab Assets include, without limitation:

 

(a)                                  domain names used in connection with the sale or promotion of Daclizumab;

 

(b)                                 all then current promotional materials, including brochures, leave-behind materials, product fact sheets, advertisements in all media;

 

(c)                                  all then current packaging art copy, and all trade dress rights thereto;

 

(d)                                 rights to any “look and feel” of any materials referenced in (a) through (c) above and used in connection with the marketing, sale or promotion of Daclizumab and any and all copyrights or other intellectual property rights appurtenant thereto;

 

(e)                                  all then current sales training materials and medical education materials;

 

(f)                                    copies of market research surveys, analyses, and reports;

 

(g)                                 then current customer lists, sales records, lists of distributors;

 

(h)                                 regulatory filings, INDs, agreements related to physician sponsored INDs (to the extent assignable), CTXs, BLAs, and foreign equivalents of the foregoing, and all associated communications with regulatory authorities in the Roche Territory (excluding manufacturing approvals); and

 

(i)                                     then current contracts with managed care groups, hospitals, transplant centers, pharmaceutical benefit managers, distributors and other similar Third Parties.

 

1.15                           “Excluded Field” means [*] that (a) [*] to the [*] of [*], (b) [*] the [*] of [*], and (c) may also [*].  The Parties agree that Daclizumab is not in the Excluded Field.

 

1.16                           “Excluded Product” means any product in the Excluded Field, including any Combination Product, that contains an [*] that was [*] by [*] on behalf of [*] pursuant to the [*]. [*] shall be deemed to be an Excluded Product.

 

1.17                           “Exercise Period” has the meaning set forth in Section 5.2(a).

 

1.18                           “FDA” means the United States Food and Drug Administration and any successor agency thereto, and/or any equivalent foreign governmental agency, depending on the context.

 

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1.19                           “Field” means any humanized or chimeric antibody that binds to IL-2R, where “humanized” means a genetically engineered combination of a substantially human framework region and constant region, and complementarity determining regions from non-human antibodies, and where “chimeric” means a genetically engineered combination of human constant region and non-human variable region.  “Antibodies in the Field” means humanized and chimeric antibodies that bind to IL-2R.  It is believed that these Antibodies in the Field may be useful for therapeutic, diagnostic, imaging and similar purposes.  It is understood that the Field includes, but is not limited to, that certain humanized murine monoclonal antibody prepared against the p55 component of IL-2R (“humanized anti-Tac”). Furthermore, the Field includes, but is not limited to, all improvements relating to humanized anti-Tac, including without limitation modifications in structure introduced by genetic engineering, or by chemical or enzymatic cleavage.  Also included within the Field shall be alternate hosts for producing humanized anti-Tac, methods for purification, formulations incorporating humanized anti-Tac, and uses and methods of use for humanized anti-Tac in human medicine.

 

1.20                           “Joint Inventions” means any inventions in the Field, whether patented or not, that are jointly made during the period beginning on January 31, 1989 and continuing until the end of the Commercialization Term by at least one (1) PDL employee or person contractually required to assign or license patent rights covering such inventions to PDL and at least one (1) Roche-Nutley or F. Roche employee or person contractually required to assign or license patent rights covering such inventions to Roche-Nutley or F. Roche.

 

1.21                           “Licensed Product” means any product, other than an Excluded Product, in the Field, including any Combination Product, the making, importation, use, offer for sale, or sale of which utilizes Roche Know-How, Roche Patents, or Joint Inventions or would, in the absence of this Amended and Restated Worldwide Agreement, infringe a Valid Claim of a Roche Patent.  Daclizumab shall be deemed to be a Licensed Product.

 

1.22                           “Major Country” means the United States, United Kingdom, France, Italy and Germany.

 

1.23                           “Other Indications” means all indications other than Transplant Indications and Autoimmune Indications.

 

1.24                           “Other Licensed Products” means all Licensed Products other than Daclizumab.

 

1.25                           “PDL Adjusted Gross Sales” means the gross invoice price of Daclizumab sold or otherwise disposed of for consideration in the Roche Territory by PDL, its Affiliates or sublicensees (other than Roche and its Affiliates hereunder) to independent Third Parties not an Affiliate of the seller, reduced by the following amounts: (a) the amounts actually allowed as volume or quantity discounts, rebates, price reductions, returns (including withdrawals and recalls); and (b) sales, excise and turnover taxes imposed directly on and actually paid by PDL, its Affiliates or sublicensees.

 

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When calculating the PDL Adjusted Gross Sales, the amount of such sales in foreign currencies shall be converted into U.S. dollars at the average rate of exchange at the time for the applicable calendar quarter in accordance with PDL’s then-current standard practices.

 

In the case of Combination Products for which Daclizumab and each of the other therapeutically active ingredients contained in the Combination Product have established market prices when sold separately, PDL Adjusted Gross Sales shall be determined by multiplying the PDL Adjusted Gross Sales for each such Combination Product by a fraction, the numerator of which shall be the established market price for the form and formulation of Daclizumab contained in the Combination Product, and the denominator of which shall be the sum of the established market prices for such form and formulation of Daclizumab plus the other active ingredients contained in the Combination Product.  When such separate market prices are not established, then the parties shall negotiate in good faith to determine the method of calculating PDL Adjusted Gross Sales for Combination Products.

 

If PDL or its Affiliates or sublicensees receive non-cash consideration for Daclizumab sold or otherwise transferred to an independent Third Party not an Affiliate of the seller or transferor, the fair market value of such non-cash consideration on the date of the transfer as known to PDL, or as reasonably estimated by PDL if unknown, shall be deemed the PDL Adjusted Gross Sales for such Daclizumab sold or otherwise transferred.

 

1.26                           PDL Know-How” means, except as otherwise set forth in this Section 1.26, all inventions, discoveries, trade secrets, information, experience, data, formulas, procedures and results in the Field, and improvements thereon, including any information regarding the physical, chemical, biological, toxicological, pharmacological, clinical, and veterinary data, dosage regimens, control assays and specifications of Daclizumab (collectively, “Know-How in the Field”), that is owned or Controlled by PDL or its Affiliates as of the Effective Date or that is developed or Controlled by PDL or its Affiliates during the term of this Amended and Restated Worldwide Agreement, and which Know-How in the Field is reasonably required or useful for manufacturing, using or selling Daclizumab; provided, however, that PDL Know-How excludes any Know-How in the Field of any kind concerning generic methods of manufacturing, designing, developing or preparing antibodies including, but not limited to, methods of humanizing antibodies, methods of reducing the immunogenicity of antibodies, and methods of increasing the affinity of antibodies.

 

1.27                           “PDL Net Sales” means the amount determined by deducting [*] from PDL Adjusted Gross Sales to cover all other expenses or discounts, including but not limited to cash discounts, custom duties, transportation and insurance charges and other direct expenses, to the extent not already deducted from the amount invoiced.

 

1.28                           “PDL Patents” means all patent applications owned or Controlled by PDL alone or with a Third Party (“Sole PDL Patents”) and all patent applications resulting from Joint Inventions (“Joint Roche-PDL Patents”) Covering Daclizumab, which are filed prior to or during the term of the 1989 Agreements, the 1999 Agreements or this Amended and Restated Worldwide Agreement in the United States or any foreign jurisdiction, including any addition,

 

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continuation, continuation-in-part or division thereof or any substitute application therefor; any patent issued with respect to such patent application, any reissue, extension or patent term extension of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent; and any other United States or foreign patent or inventor’s certificate covering products in the Field.

 

1.29                           “PDL Sole Territory” means all countries of the world, as listed in Appendix C (which the parties may agree to update from time to time), with respect to which Roche has granted an exclusive license to PDL, in connection with the previous return or reversion of Roche’s rights under the 1999 Agreements.

 

1.30                           “Product Operating Committee” or “POC” has the meaning set forth in Section 6.2(a).

 

1.31                           “Put Exercise Fee” has the meaning set forth in Section 5.3(b).

 

1.32                           “Put Right Effective Date” has the meaning set forth in Section 5.3(a).

 

1.33                           “Queen et al. Patents” means those Sole PDL Patents in the Territory claiming priority under 35 USC 120 to U.S. Patent Application Serial No. 290,975, filed December 28, 1988.

 

1.34                           “Reasonable Diligence” means the same level of effort used by Roche in developing, registering, marketing and selling its own protein-based products that must be approved by the FDA before they can be sold in the Roche Territory.  The parties acknowledge that Roche does not develop, register, market and sell its own protein-based products in every country within the Roche Territory, and it is understood that the exercise by Roche of reasonable diligence shall be determined by judging its efforts in the Roche Territory taken as a whole.

 

1.35                           “Regulatory Approval” means the granting of all governmental regulatory approvals required, if any, for the sale of a Licensed Product in a given country or jurisdiction within the Territory.

 

1.36                           “Reversion Effective Date” has the meaning set forth in Section 5.2(b).

 

1.37                           “Reversion Exercise Fee” has the meaning set forth in Section 5.2(c).

 

1.38                           “Roche Adjusted Gross Sales” means the gross invoice price of Daclizumab sold or otherwise disposed of for consideration by Roche, its Affiliates or sublicensees (other than PDL and its Affiliates hereunder) to independent Third Parties not an Affiliate of the seller, reduced by the following amounts: (a) the amounts actually allowed as volume or quantity discounts, rebates, price reductions, returns (including withdrawals and recalls); and (b) sales, excise and turnover taxes imposed directly on and actually paid by Roche, its Affiliates or sublicensees.

 

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When calculating the Roche Adjusted Gross Sales, the amount of such sales in foreign currencies shall be converted into U.S. dollars at the average rate of exchange at the time for the applicable calendar quarter in accordance with Roche’s then-current standard practices.

 

In the case of Combination Products for which Daclizumab and each of the other therapeutically active ingredients contained in the Combination Product have established market prices when sold separately, Roche Adjusted Gross Sales shall be determined by multiplying the Roche Adjusted Gross Sales for each such Combination Product by a fraction, the numerator of which shall be the established market price for the form and formulation of Daclizumab contained in the Combination Product, and the denominator of which shall be the sum of the established market prices for such form and formulation of Daclizumab plus the other active ingredients contained in the Combination Product.  When such separate market prices are not established, then the parties shall negotiate in good faith to determine the method of calculating Roche Adjusted Gross Sales for Combination Products.

 

If Roche or its Affiliates or sublicensees receive non-cash consideration for Daclizumab sold or otherwise transferred to an independent Third Party not an Affiliate of the seller or transferor, the fair market value of such non-cash consideration on the date of the transfer as known to Roche, or as reasonably estimated by Roche if unknown, shall be deemed the Roche Adjusted Gross Sales for such Daclizumab sold or otherwise transferred.

 

1.39                           “Roche Commercialization Activities” has the meaning set forth in Section 4.1(a).

 

1.40                           “Roche Controlled Patents” means all patent applications Controlled by Roche or its Affiliates and not Controlled by PDL or its Affiliates Covering inventions in the Field that are filed prior to or during the term of this Amended and Restated Worldwide Agreement in the United States or any foreign jurisdiction, including any addition, continuation, continuation-in-part or division thereof or any substitute application therefor; any patent issued with respect to such patent application, any reissue, extension or patent term extension of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent; and any other United States or foreign patent or inventor’s certificate covering inventions in the Field.  Roche Controlled Patents are, specifically, those listed on Schedule 2.8(b).

 

1.41                           “Roche Inventions” means any inventions in the Field that are made prior to or during the term of this Amended and Restated Worldwide Agreement by employees of Roche or persons contractually required to assign or license patent rights covering such inventions to Roche.

 

1.42                           “Roche Know-How” means all Know-How in the Field that is owned or Controlled by Roche or its Affiliates as of the Effective Date, or that is developed or Controlled by Roche or its Affiliates during the Commercialization Term and which Know-How in the Field is reasonably required or useful for seeking registration of, manufacturing, using or selling Daclizumab, as the case may be, provided, however, that this portion of Roche Know-How excludes any Know-How in the Field of any kind concerning generic methods of manufacturing,

 

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designing, developing or preparing antibodies including, but not limited to, methods of humanizing antibodies, methods of reducing the immunogenicity of antibodies, and methods of increasing the affinity of antibodies.  For clarity, Roche Know-How includes all Know-How in the Field provided to PDL by Roche or its Affiliates under the 1989 Agreements and 1999 Agreements.

 

1.43                           “Roche Licensed Know-How” means that portion of Roche Know-How that is reasonably required or useful for seeking registration of, manufacturing, using or selling Daclizumab for Autoimmune Indications or any Other Indication, but shall not include [*].

 

1.44                           “Roche Licensed Patents” means those Roche Patents that Cover in whole or in part the manufacture, importation, offer for sale or sale of Daclizumab or any Other Licensed Products, or the use of Daclizumab or any Other Licensed Products in Autoimmune Indications or Other Indications.

 

1.45                           “Roche Net Sales” means the amount determined by deducting [*] from Roche Adjusted Gross Sales to cover all other expenses or discounts, including but not limited to cash discounts, custom duties, transportation and insurance charges and other direct expenses, to the extent not already deducted from the amount invoiced.  Notwithstanding the foregoing, “Roche Net Sales of Excluded Products” shall be calculated in the same manner as Roche Net Sales, except that for the purpose of such calculation, Roche Adjusted Gross Sales shall be based on the gross invoice price of Excluded Products.

 

1.46                           “Roche Owned Patents” means all patent applications owned by Roche or its Affiliates (“Sole Roche Patents”) alone or with a Third Party, and all patent applications resulting from Joint Inventions (“Joint Roche-PDL Patents”) covering inventions in the Field that are filed prior to or during the term of this Amended and Restated Worldwide Agreement in the United States or any foreign jurisdiction, including any addition, continuation, continuation-in-part or division thereof or any substitute application therefor; any patent issued with respect to such patent application, any reissue, extension or patent term extension of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent; and any other United States or foreign patent or inventor’s certificate covering inventions in the Field.  Roche Owned Patents as of the Effective Date are, specifically, those listed on Schedule 2.8(a).

 

1.47                           “Roche Patents” means both the Roche Owned Patents and the Roche Controlled Patents.

 

1.48                           “Roche Products” means Daclizumab and any Excluded Products.

 

1.49                           “Roche Put Right” has the meaning set forth in Section 5.3(a).

 

1.50                           “Roche Territory” means, collectively, (a) the United States of America (“U.S.” or “U.S.A.” or “United States”) and its territories and possessions where the patent laws of the

 

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United States are in force and (b) all other countries in the Territory, excluding the PDL Sole Territory (the “Roche ROW Territory”).

 

1.51                           “Territory” means all the countries of the world.

 

1.52                           “Third Party” means any person or entity other than PDL, Roche, and their respective Affiliates.

 

1.53                           “Third Party License” means (a) any of the license agreements set forth on Appendix B that were entered into by either party, prior to the Effective Date, in order for Roche or PDL to manufacture, use, import, offer for sale or sell Daclizumab or (b) any license agreement entered into with a Third Party by either party in accordance with Section 7.4(b).

 

1.54                           “Trademarks” means the trademark “Zenapax®,” and all trademark registrations and applications therefor, and all goodwill associated therewith, and all other trademarks owned by Roche (except for any Roche housemarks or trade names) and used in connection with the sale or promotion of Daclizumab in the Roche Territory.

 

1.55                           “Transplant Foreign Filing Expenses” means ex parte out-of-pocket expenses (a) incurred by PDL after January 31, 1989, but prior to the Effective Date, in connection with the prosecution and maintenance in the Roche ROW Territory of patent applications and patents included within the PDL Patents or Joint Roche-PDL Patents and (b) reimbursed by Roche pursuant to Section 7.2(a) of the 1999 PDL/Roche Agreement or Section 5.3(a) of the F. Roche Agreement.

 

1.56                           “Transplant Indications” means all indications that involve the suppression of rejection of transplanted organs, bone marrow or other tissue, including, without limitation, solid organ transplantation (including tolerance induction and xenotransplantation), bone marrow transplantation, graft versus host disease and cell transplantation.  In any event, if a given indication satisfies the criteria for both an Autoimmune Indication and a Transplant Indication, such indication shall be deemed a Transplant Indication and not an Autoimmune Indication, provided that an Autoimmune Indication shall not be deemed a Transplant Indication merely because it may cause the need for a transplant (e.g., Type I diabetes, even if it causes the need for an organ transplant).

 

1.57                           “Transplant Reversion” has the meaning set forth in Section 5.2(a).

 

1.58                           “Valid Claim” means a claim in any issued patent that has not been disclaimed or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction by a decision beyond right of review.

 

II.  LICENSE GRANTS

 

2.1                                 License Grant to PDL On Effective Date.

 

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(a)                                  Subject to the terms and conditions of this Amended and Restated Worldwide Agreement, Roche grants to PDL and to PDL’s Affiliates the worldwide right and license under the Roche Licensed Know-How and Roche Licensed Patents, to (i) develop, use, market, promote, and detail Daclizumab in the Territory solely for use in Autoimmune Indications and/or the Other Indications, and (ii) sell and offer for sale Daclizumab in the Territory, under the AI Trademarks.

 

(b)                                 The licenses set forth in Sections 2.1(a)(i) and 2.1(a)(ii) shall be exclusive (even as to Roche) with respect to the Roche Licensed Know-How and Roche Licensed Patents that Roche or its Affiliate solely owns or has an exclusive license.  With respect to the Roche Licensed Know-How and Roche Licensed Patents to which Roche or its Affiliate has a non-exclusive license, such licenses shall be sole, non-exclusive licenses.  With respect to the Roche Licensed Know-How and Roche Licensed Patents that Roche or its Affiliate jointly owns, such licenses shall be sole licenses under Roche’s interest in such Roche Licensed Know-How and Roche Licensed Patents.  As used in this Section 2.1(b) a “sole” license means that the Roche will not grant to any Third Party a license that overlaps with the scope of the licenses granted to PDL under Section 2.1(a).

 

(c)                                  Roche grants to PDL and to PDL’s Affiliates, the nonexclusive right under the Roche Licensed Know-How and Roche Licensed Patents to make, have made, and import Daclizumab.

 

(d)                                 PDL and its Affiliates may sublicense the rights and licenses granted to them under Sections 2.1(a) and (c) to any Affiliate or Third Party, with the right to further sublicense; provided, however, that without Roche’s written consent, PDL shall not have the right to sublicense, during the Commercialization Term, any of the [*] rights or licenses in Section 2.1(a) to any other entity, that is, as of the time of such sublicensing, [*] in the [*] (in at least one [*] with [*]), or [*] in the [*] any [*] for the [*] of [*] in any [*].  It is expressly understood and agreed by Roche that PDL shall have the right to sublicense its rights under Sections 2.1(a) and (c) to [*].  Notwithstanding the preceding limitation on sublicensing, PDL and its Affiliates may use Third Party distributors in accordance with their customary practices.

 

(e)                                  Subject to the terms and conditions of this Amended and Restated Worldwide Agreement, Roche grants to PDL and to PDL’s Affiliates a worldwide right and license (or sublicense, as the case may be) under the Roche Licensed Know-How received by PDL pursuant to the 1989 Agreements, 1999 Agreements or Section 2.4 hereof, the Roche Controlled Patents and only those Roche Owned Patents listed in Schedule 2.8(a), to (i) develop, use, market, promote, and detail Other Licensed Products in the Territory solely for use in Autoimmune Indications and/or the Other Indications; (ii) sell and offer for sale Other Licensed Products in the Territory; and (iii) to make, have made, and import Other Licensed Products in the Territory.

 

(f)                                    The license set forth in Section 2.1(e) shall be exclusive (even as to Roche) with respect to the Roche Controlled Patents that Roche or its Affiliate solely owns or has an exclusive license.  With respect to the Roche Controlled Patents to which Roche or its Affiliate has a non-exclusive license, such license shall be a sole, non-exclusive license.  With respect to

 

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the Roche Owned Patents that Roche or its Affiliate jointly owns, such license shall be a sole license under Roche’s interest in such Roche Owned Patents.  PDL and its Affiliates shall have the right freely to sublicense, through multiple tiers, the rights and licenses granted to them under Section 2.1(e).  Notwithstanding anything to the contrary in Section 2.1(e), the license to Roche Licensed Know-How shall be non-exclusive.  Roche hereby covenants that, until the termination, pursuant to Section 2.2(a), of the license set forth in Section 2.1(e), it will not grant to any Third Party any right or license under the (i) Roche Controlled Patents to which Roche or its Affiliate has a non-exclusive license or (ii) Roche Owned Patents that Roche or its Affiliate jointly owns, to (A) develop, use, market, promote, and detail Other Licensed Products in the Territory for use in Autoimmune Indications and/or the Other Indications; (B) sell and offer for sale Other Licensed Products in the Territory; and (C) make, have made, and import Other Licensed Products in the Territory.

 

(g)                                 If PDL wishes to receive a license with respect to Other Licensed Products in Autoimmune Indications and/or Other Indication, under any Roche Owned Patents that are not listed in Schedule 2.8(a), it shall [*] and Roche shall [*].

 

2.2                                 License Grant to PDL On Reversion Effective Date or Put Right Effective Date.

 

(a)                                  Effective only on the Reversion Effective Date or the Put Right Effective Date, Roche hereby grants the following license to PDL: subject to the terms and conditions of this Amended and Restated Worldwide Agreement, Roche grants to PDL and to PDL’s Affiliates a worldwide right and license under the Roche Know-How and Roche Patents, to develop, use, manufacture, have manufactured, market, promote, import, offer for sale, sell and have sold Daclizumab and all Other Licensed Products in the Field and in the Territory.  On the effectiveness of the license set forth in this Section 2.2(a), the licenses granted in Section 2.1(a), (c) and (e) shall terminate.  PDL and its Affiliates shall have the right freely to sublicense, with the right to further sublicense, the right and license granted to them under this Section 2.2(a).

 

(b)                                 For Daclizumab, the license set forth in Section 2.2(a) shall be exclusive (even as to Roche) with respect to the Roche Know-How and Roche Patents that Roche or its Affiliate solely owns or has an exclusive license.  With respect to the Roche Know-How and Roche Patents to which Roche or its Affiliate has a non-exclusive license, the license set forth in Section 2.2(a) shall be a sole, non-exclusive license.  With respect to the Roche Know-How and Roche Patents that Roche or its Affiliate jointly owns, the license set forth in Section 2.2(a) shall be a sole license under Roche’s interest in such Roche Know-How and Roche Patents.  Roche hereby covenants that it will not grant to any Third Party any right or license, under (i) the Roche Know-How and Roche Patents to which Roche or its Affiliate has a non-exclusive license or (ii) the Roche Know-How and Roche Patents that Roche or its Affiliate jointly owns, to develop, use, manufacture, have manufactured, market, promote, import, offer for sale and sell Daclizumab in the Field and in the Territory.

 

(c)                                  For Other Licensed Products, the license set forth in Section 2.2(a) shall be non-exclusive.  Notwithstanding the preceding sentence, Roche hereby covenants that it will not

 

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grant licenses to any Third Party under the Roche Patents to make, have made, use, sell, offer for sale or import any Other Licensed Product.

 

2.3                                 Certain [*] To PDL of [*] Intellectual Property.  PDL acknowledges and understands that [*] are [*] as to [*] (a) Roche has received, prior to the Effective Date, a [*] license under certain [*] of [*] that [*] cover the manufacture, use, importation, offer for sale or sale of humanized antibodies against IL-2R, including Daclizumab and any Other Licensed Products, and/or (b) [*] Roche has the right to [*] such licensed [*], to the extent granted to Roche.   In the event that the parties agree that Roche is [*] such license [*], PDL shall be deemed to have been [*] pursuant to the [*], as applicable, and such [*] will be deemed part of the [*] licensed thereunder.  In the event that the parties agree that Roche [*] such rights, and/or that Roche [*] such rights to PDL as part of the [*], Roche agrees to use diligent efforts to itself secure or assist PDL