1.28
"GENERIC PRODUCT" MEANS ANY PHARMACEUTICAL PRODUCT THAT
(A) CONTAINS A LICENSED COMPOUND; (B) IS SOLD BY A THIRD PARTY THAT IS NOT A
LICENSEE OR SUBLICENSEE OF LILLY OR ITS AFFILIATES, UNDER A MARKETING
AUTHORIZATION GRANTED BY A REGULATORY AUTHORITY TO SUCH THIRD PARTY; ***.
1.29
"HEMATOLOGY FIELD" MEANS THE TREATMENT, CONTROL, MITIGATION,
PREVENTION, CURE, OR DIAGNOSIS OF ALL HEMATOLOGIC INDICATIONS AS DEFINED IN
SUBSECTIONS 280 - 289 (DISEASES OF THE BLOOD AND BLOOD-FORMING ORGANS) OF THE
INTERNATIONAL CLASSIFICATION OF DISEASES, NINTH REVISION, CLINICAL MODIFICATION
(ICD-9-CM), AS SET FORTH IN EXHIBIT E.
1.30
"HSR ACT" MEANS THE HART-SCOTT-RODINO ANTITRUST IMPROVEMENTS ACT OF
1976, AS AMENDED (15 U.S.C. §18A), AND THE RULES AND REGULATIONS PROMULGATED
THEREUNDER.
1.31
"INCYTE IP" MEANS INCYTE KNOW-HOW AND INCYTE PATENT RIGHTS.
1.32
"INCYTE KNOW-HOW" MEANS ALL KNOW-HOW THAT (A) IS CONTROLLED BY
INCYTE OR ANY OF ITS AFFILIATES AS OF THE EFFECTIVE DATE OR DURING THE TERM; AND
(B) IS NECESSARY OR USEFUL TO DEVELOP, MANUFACTURE OR COMMERCIALIZE ANY LICENSED
COMPOUNDS OR LICENSED PRODUCTS.
1.33
"INCYTE PATENT RIGHTS" MEANS ALL PATENT RIGHTS THAT (A) ARE
CONTROLLED BY INCYTE OR ANY OF ITS AFFILIATES AS OF THE EFFECTIVE DATE OR DURING
THE TERM; AND (B) (I) COVERS A LICENSED COMPOUND OR LICENSED PRODUCT, A
COMPOSITION CONTAINING LICENSED COMPOUND, A FORMULATION CONTAINING A LICENSED
PRODUCT OR (II) ARE OTHERWISE NECESSARY TO DEVELOP, MANUFACTURE OR COMMERCIALIZE
ANY LICENSED COMPOUNDS OR LICENSED PRODUCTS.
THE INCYTE PATENT RIGHTS THAT
EXIST AS OF THE EFFECTIVE DATE ARE SET FORTH IN EXHIBIT A (A-1 AND A-2).
1.34
"IND" MEANS AN INVESTIGATIONAL NEW DRUG APPLICATION FILED WITH THE
FDA UNDER 21 C.F.R. PART 312 OR SIMILAR NON-UNITED STATES APPLICATION OR
SUBMISSION IN ANY COUNTRY OR GROUP OF COUNTRIES FOR PERMISSION TO CONDUCT HUMAN
CLINICAL INVESTIGATIONS.
1.35
"INDICATION" MEANS ANY DISEASE, CONDITION OR SYNDROME.
1.36
"INFLAMMATORY DISEASE" MEANS ANY INFLAMMATORY DISEASE, INCLUDING
THE FOLLOWING INDICATIONS: RHEUMATOID ARTHRITIS (AND OTHER ARTHRITIDES INCLUDING
JUVENILE RA, ANKYLOSING SPONDYLITIS, SERO-NEGATIVE SPONDYLOARTHROPATHIES AND
PSORIATIC ARTHRITIS), INFLAMMATORY BOWEL DISEASE (ULCERATIVE COLITIS AND CROHN'S
DISEASE), ASTHMA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, MULTIPLE SCLEROSIS,
SYSTEMIC LUPUS ERYTHMATOSUS AND PSORIASIS.
NOTWITHSTANDING THE FOREGOING,
INFLAMMATORY DISEASE SPECIFICALLY EXCLUDES ANY INDICATION INCLUDED IN THE
EXCLUDED FIELD.
5
*** Confidential material redacted and filed separately with the Commission.
1.37
"INTELLECTUAL PROPERTY RIGHTS" MEANS PATENT RIGHTS, TRADE SECRETS,
COPYRIGHTS AND OTHER FORMS OF PROPRIETARY OR INDUSTRIAL RIGHTS PERTAINING TO
INVENTIONS, KNOW-HOW, ORIGINAL WORKS, AND OTHER FORMS OF INTELLECTUAL PROPERTY.
1.38
"INVENTIONS" MEANS ALL PATENTABLE INVENTIONS, DISCOVERIES,
IMPROVEMENTS AND OTHER TECHNOLOGY AND ANY PATENT RIGHTS BASED THEREON, THAT ARE
DISCOVERED, MADE OR CONCEIVED DURING AND IN CONNECTION WITH THE RESEARCH,
DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION OF LICENSED COMPOUNDS OR LICENSED
PRODUCTS.
1.39
"JAK" MEANS HUMAN JAK TYROSINE KINASE.
1.40
"JAK1" MEANS JAK1 TYROSINE KINASE.
1.41
"JAK2" MEANS JAK2 TYROSINE KINASE.
1.42
"JAK EXCLUDED COMPOUND" MEANS ***.
1.43
"JAK2 INHIBITOR COMPOUND" MEANS *** IN SCHEDULE 1.43.
1.44
"KNOW-HOW" MEANS ANY INFORMATION, IDEAS, DATA, INVENTIONS, WORKS OF
AUTHORSHIP, TRADE SECRETS, TECHNOLOGY, OR MATERIALS, INCLUDING FORMULATIONS,
MOLECULES, ASSAYS, REAGENTS, COMPOUNDS, COMPOSITIONS, HUMAN